Texas Governor undergoes surgery using adult stem cells

Connie

New member
http://www.texastribune.org/texas-people/rick-perry/perrys-surgery-included-experimental-stem-cell-the/

Perry's Surgery Included Experimental Stem Cell Therapy

When Gov. Rick Perry emerged from back surgery on July 1, he tweeted that his “little procedure” — a spinal fusion and nerve decompression designed to treat a recurring injury — had gone “as advertised.”

The possible presidential contender didn’t reveal that he’d undergone an experimental injection of his own stem cells, a therapy that isn’t FDA approved, has mixed evidence of success and can cost upwards of tens of thousands of dollars.

The governor’s procedure did not involve embryonic stem cells, which he and many other conservatives ardently oppose using for medical research on both religious and moral grounds. His treatment involved removing his own adult stem cells from healthy tissue and injecting them back into his body at the time of surgery, with the belief that the cells would assist tissue regeneration and speed recovery.

In a statement on Wednesday, Perry spokesman Mark Miner called the procedure “successful” and confirmed that it included “the innovative use of his own adult stem cells.”

While some doctors and biomedical engineers swear by the benefits of this relatively new science and offer the therapy to patients with everything from slipped discs to cardiac disease, stem cell experts say there’s still little clinical evidence — aside from research on animals and small-scale human studies — that it’s effective.

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The FDA, which is in litigation over its authority to regulate new stem cell clinics, has not approved the use of adult stem cells for anything other than bone marrow transplants, which have been used for decades to treat cancer and sickle cell anemia patients. This has largely kept doctors from openly advertising these stem cell injections, but not from capitalizing on them by offering the therapy to their patients.

It also hasn’t stopped Perry from pushing for adult stem cell research and industry in Texas. During the governor’s 2009 State of the State address, he called on state leaders to invest in adult stem cell companies. Later that year, his Emerging Technology Fund awarded a $5 million grant to the Texas A&M Health Science Center Institute of Regenerative Medicine and $2.5 million to Helotes-based America Stem Cell to develop new adult stem cell technology.

Last month, three weeks after his adult stem cell treatment, Perry wrote a letter to the Texas Medical Board, which is considering new rules regarding adult stem cells, saying that he hoped Texas would “become the world’s leader in the research and use of adult stem cells.” He asked board members to “recognize the revolutionary potential that adult stem cell research and therapies have on our nation’s health, quality of life and economy.”

In the weeks since the procedure, the governor has traded his cowboy boots for orthopedic shoes and donned a back brace, raising questions that his recovery may be slow-going. Still, he has traveled extensively; in an interview with The Associated Press last week, Perry said he felt 80 percent recovered and was swimming and using the treadmill.

As for the high cost of such stem cell injections, Miner said that whatever health insurance didn’t pay for, “Perry did.”

It’s unclear exactly how Perry’s procedure went; in many cases, doctors pull stem cells from the patient’s fatty tissue or blood, clean the cells in culture and then, several weeks later, inject the cells back into the patient, either into the blood stream or at the site of the surgery. Houston orthopedic spine surgeon Stanley Jones, who performed Perry’s stem cell infusion, did not return phone messages left at his office on Wednesday.

In May 2010, Jones made a high-profile trip to Kyoto, Japan, to get infused with his own stem cells to treat autoimmune arthritis. A January press release from RNL BIO, the South Korea-based stem cell company that treated him, reported that he had a complete recovery within five months.

The infusion of adult stem cells to repair tissue and organ damage is highly controversial. For every Bartolo Colon, the New York Yankees pitcher whose near-miraculous comeback is being attributed to the procedure, researchers say there are botched jobs and patients who spend tens of thousands of dollars with no results.

The biomedical engineers and spinal clinics developing stem cell products and performing the procedure say they’re seeing terrific results.

“They have been outstanding given how new the field is,” said Kevin Dunworth, founder and CEO of Austin-based Celling Technologies and SpineSmith, which prepares the adult stem cells for about 450 procedures in the U.S. every month, a quarter of them in Texas. “The added value of stem cells is that they’re wonderful at mitigating pain on a long-term basis, and they do it quite rapidly, within three to five days.”

But researchers say that despite the great potential adult stem cells may have, so far they’ve seen nothing more definitive than the so-called “placebo effect” — patients who convince themselves they’re feeling better simply by nature of having had the procedure. In some lab tests, stem cells that have been effectively deprogrammed to help regenerate a particular organ have appeared to turn cancerous. In others, patients have traveled around the world, spending $10,000 to $50,000 for stem cells that simply die off, with no effect on health.

“Most of this stuff is pretty experimental at this point,” said Heather Rooke, the science director for the International Society for Stem Cell Research. “People are pushing these things into the clinic before there’s real evidence of safety or an indication that they’ll work.”
 

barbara

Pioneer Founding member
Interesting post Connie. On the one hand you have a doctor who is an orthopedic surgeon treating the Governor of the state of Texas, both proclaiming good results after the treatment and on the other hand you have the ISSCR still lamenting that there is no evidence that a procedure like this works. Never mind what the patient or his doctor says. Of course, it is all the placebo effect which I am sure Governor Perry is aware of as he works out on the treadmill and swims once again.
 

Kaye

New member
Connie

Great post. Adult stem cells need all the publicity they can get. Here's a little info on Governor Perry's doctor, orthopedic spine surgeon Stanley Jones, who also had stem cell treatment using adult cells. It seems to be getting more and more difficult for the ISSCR to continue to call these treatments "the placebo effect" when doctors are using them to heal themselves. Reminds me of the neurosurgeon that Dr. Centeno treated that ran the Ironman Hawaii and then called for more research. The ISSCR's argument is no longer credible. OR, we can go to our physicians and tell them we WANT THE PLACEBO EFFECT! NOW! Stop wasting my tax dollars. The country is broke and I hope your job just left town with the last budget agreement! Wishful thinking???????


http://www.redorbit.com/news/health/1985805/american_orthopedic_spine_surgeon_successfully_treated_for_autoimmune_arthritis_with/
American Orthopedic Spine Surgeon Successfully Treated for Autoimmune Arthritis with His Own Stem Cells
Posted on: Wednesday, 26 January 2011, 15:41 CST

GERMANTOWN, Md., Jan. 26, 2011 /PRNewswire/ -- RNL BIO CO., LTD, a leading biopharmaceutical company specialized in adult stem cell therapeutics, announced on January 21, 2011 another successful patient report utilizing stem cell therapy on a leading US orthopedic spine surgeon who suffered from Autoimmune Arthritis.


Dr. Stanley Jones, the surgeon and patient, reports that he had a sudden onset of acute pain in his wrist in September 2009; shortly thereafter the patient experiences pain in his knees as well. Dr. Jones saw a rheumatologist who diagnosed him with Autoimmune Arthritis. He was placed on Cortisone, a steroid hormone, to suppress immune response and alleviate pain. Unfortunately Dr. Jones suffered complications from the Cortisone including chest pain and Candidiasis which were unbearable. His condition deteriorated and his ability to perform routine activities of daily living or his profession was impacted.


After visiting many physicians and talking with experts in the field, Dr. Jones was introduced to RNL Bio's stem cell therapy. After a workup, he received stem cell infusions in Kyoto, Japan in May 2010. Post infusion, he began to notice improvement and by the 5 month, he had a complete recovery and was able to resume sports as well as operating! In addition, he no longer needed any medications including Cortisone or Methotrexate. Dr. Jones' rheumatologist in Houston saw Dr. Jones post infusion and said, "It is amazing that Dr. Jones was able to experience improvement from cutting-edge medical technology."

Other patients treated by the company have had very successful results as reported by RNL BIO Co., Ltd in 2009, an American artist, John Cullison's stem cell treatment for Rheumatoid Arthritis, and in September 2010, Japanese Yosida's treatment for psoriasis.


About RNL BIO CO., LTD.


RNL BIO is a premier biotechnology company focused on the research and development of adult derived stem cell therapies. RNL has two therapies in Phase II clinical trials for Buerger's Disease as well as Osteoarthritis and one phase I trial for spinal cord injury. RNL is a publicly traded company on the Korean Stock Exchange (Code 003190) and is expanding its operations throughout the world.


SOURCE RNL BIO CO., LTD.

Source: PR Newswire
 

Everett

New member
Governor Rick Perry of the great state of TEXAS

I read this info on his treatment with stem cells and I couldn't believe that he and the press are treating his treatment so positively and openly. I for one think that he would make our great nation a super fine president and would be a one up for stem cell treatment and research for our people. I won't state my opinion of the current politicos in government but I think the good ol' U.S. of A. deserves better. God bless Her.
 

Kaye

New member
Everett

Story just keeps getting better. Possible MS human trial in Texas? Looks like Texas is moving ahead!

http://www.star-telegram.com/2011/08/04/3270713/perry-had-injection-of-stem-cells.html

Perry had injection of stem cells during surgery
Posted Friday, Aug. 05, 2011 2 Comments Print Reprints
Share Topics: Health, Food Safety, Food and Drug Administration, Texas Colleges & Universities, U.S. Leaders

The Texas Tribune

When Gov. Rick Perry emerged from back surgery July 1, he tweeted that his "little procedure" -- a spinal fusion and nerve decompression designed to treat a recurring injury -- had gone "as advertised."

The possible presidential contender didn't reveal that he had undergone an experimental injection of his own stem cells, a therapy that isn't FDA approved, has mixed evidence of success and can cost tens of thousands of dollars.

The governor's procedure did not involve embryonic stem cells, which he and many other conservatives ardently oppose using for medical research on both religious and moral grounds. His treatment involved removing his own adult stem cells from healthy tissue and injecting them back into his body at the time of surgery, in the belief that the cells would assist tissue regeneration and speed recovery.

The doctor who performed the procedure said this week that he had never done it before he did it for the governor, who could announce a run for the presidency any day.

Texas stem cell bank


Now comes word that over the last two months, Perry, a state representative with multiple sclerosis and the spine surgeon who performed the governor's adult stem cell transfusion have been laying the foundation for the commercialization of the controversial procedure in Texas.


In the month before Dr. Stanley Jones injected Perry during a spinal fusion -- designed to speed recovery of the governor's back injury -- lawmakers passed a healthcare bill that quietly authorized creation of a state adult stem cell bank.

That amendment was added, with input from the governor's office, by Rep. Rick Hardcastle, R-Vernon, who has MS and says he is about to start receiving stem cell infusions from Jones as part of a new human trial.

And in the weeks since Perry's stem cell infusion, the Texas Medical Board has held a stakeholder meeting -- largely at the governor's and Jones' direction -- to discuss how to regulate the procedure in Texas.

It's pretty clear where Perry stands: Two days before last week's Medical Board meeting, Perry sent a letter to the board chairman espousing the economic and life-altering potential of adult stem cells and asking members to recognize "the sound science and good work that is already being done" as they consider new regulations.

Firm also clones dogs


Injecting patients with their own stem cells is a hotly debated practice: While some physicians swear by the procedure's restorative properties, others argue that it has little clinical evidence of success.

The procedure has sparked a national debate over where doctors' medical autonomy ends and FDA regulation begins.

Central to the debate in Texas is Jones, a Houston orthopedic surgeon and a friend of Perry's and Hardcastle's who believes that he was cured of debilitating arthritis by having an infusion of his own stem cells in Japan.

Jones is working, along with a Korean company best known for cloning dogs and marketing "stem cell cosmetics," to launch the adult stem cell business in Texas. Jones said he has no financial stake in the Korean company but would like to have a business relationship with it someday.

A first step could be a stem cell bank. The amendment Hardcastle stuck onto an omnibus healthcare bill during June's special session authorizes the state's health and human services commissioner to establish an "autologous" adult stem cell bank -- a place for patients to store their own stem cells for future use.

Hardcastle said the governor's office didn't ask him to carry it -- as the only member of the Legislature with MS, he said, it has been on his mind for "a long time" -- but one of the governor's staffers did advise him on it.

Somewhat involved, Hardcastle said, was Jones, who has already removed some of Hardcastle's stem cells to prepare them for re-injection.

Next breakthrough?


Jones has been a staunch advocate for the healing properties of adult stem cells since last year, when he says he was effectively cured of arthritis. Like the governor, Jones, who is an associate professor at the University of Texas Medical School at Houston and the founder a Houston medical day spa, staunchly opposes research into embryonic stem cells.

Reached by cellphone in Vail, Colo., late Wednesday, Jones said that Perry believes adult stem cell therapy is the next big breakthrough in medicine, and that the governor had done so much research that he had no qualms about the procedure.

"He said, 'You know I don't mind being the first. I like it,'" Jones said.

Perry's office confirmed Wednesday that the governor had the stem cell procedure during a July 1 spinal fusion to treat a recurring back injury. Reached Thursday morning, Perry spokesman Mark Miner said the governor "has full confidence in his medical staff, in those who provided his care."

No FDA approval yet


The adult stem cell procedure Jones performed is the subject of fierce debate, largely because it isn't FDA-approved, has had mixed success and can cost tens of thousands of dollars. (Insurance doesn't cover it.)

Some doctors are firmly convinced that the therapy has near-miraculous effects and can regenerate muscle and tissue in sick or injured patients.

Others say that there's scant clinical evidence that it's effective and that the success stories are largely anecdotal.

Jones is completely convinced.

Last year, he and his wife traveled to South Korea's RNL BIO, a biotechnology firm that prepares adult stem cells for infusion, Jones with arthritis so severe he couldn't operate, his wife with a vascular condition. They had their stem cells re-injected in Japan -- it's illegal in South Korea -- and within months had seen life-changing results.
 

barbara

Pioneer Founding member
Hooray for Texas. Dr. Jones' involvement with stem cells is on a more in depth level than this article states from what I have heard. I am confident that an announcement will be forthcoming and that Texas will open the door for what is lacking for the most part in the U.S. today - clinically relevant, legal stem cell therapy.
In order to make therapy more than a shot in the dark, studies really are needed and very few clinics really want to take the time and money involved to do them. Dr Centeno is an exception to this and look how he has been pursued by the FDA! Simply treating patients and sending them home with little or no follow up except to tell them to call to schedule another appointment, is the norm at a very high percentage of clinics.
Having Governor Perry be the recipient of stem cell therapy himself, is the shot in the arm perhaps that will finally get the ball rolling. Having a wealthy doctor to give him the therapy who has also had the therapy is just icing on the cake. More power to these guys!
 

barbara

Pioneer Founding member
I am not sure what this prayer day has to do with Governor Perry's stance on stem cell therapy and treatment? Do you know of a tie in Danny? I couldn't find one in the article, but maybe I missed something.

Here's more news:

Gov. Rick Perry's Controversial Surgery Sparks Debate

By Emily P. Walker, Washington Correspondent, MedPage Today
Published: August 05, 2011


Texas Gov. Rick Perry received an injection of his own stem cells during spinal fusion surgery last month and wants his state to be a leader in the use of adult stem cells in medical treatment.

But using a concentrated mixture of adult stem cells to fuse bone hasn't been tested in any major U.S. trials, raising questions of whether a governor (and reportedly a potential Republican presidential candidate) should be advocating an unproven medical procedure.

Perry and a state representative who has multiple sclerosis championed a healthcare bill that created an adult stem cell bank in Texas. A month after Perry signed that bill into law, his friend, Stanley Jones, MD, a Houston-based orthopedist, performed spinal fusion surgery on the governor using Perry's own stem cells to treat a recurring spinal injury, according to an article in the Texas Tribune.

The Tribune also said that Jones is a major advocate for adult stem cell therapy: Jones says he was cured of his debilitating arthritis after receiving injections of his own stem cells in Japan.

Experts contacted by ABC News/MedPage Today, who weren't familiar with the specifics of Perry's surgery, guessed that the governor had mesenchymal stem cells cultured from a biopsy of his own marrow or fat, that those cells were concentrated in a lab, and then were reinjected onto a scaffold-like device implanted in the spine.

Following the surgery, according to the Texas Tribune, Perry and Jones reportedly urged the Texas Medical Board to hold a meeting to explore ways to regulate the procedure in Texas.

The procedure is similar to spinal fusion surgery using a piece of bone harvested from the patient's own iliac crest to fuse two or more vertebrae. However, mesenchymal stem cells have a higher stem cell concentration than what is found in the iliac crest, and after the cells are spun in a centrifuge, the stem cells become even more concentrated.

Mesenchymal stem cells differ from iliac bone cells because they are multipotent, meaning they can turn into bone, fat, cartilage, muscle, and skin.

There have not been any phase III clinical trials that tested the utility and safety of stem cell spinal fusion procedures, nor have there been any published trials of the procedure in the U.S.

A Chinese study randomized 56 patients with degenerative disc disorder, lumbar instability, or spinal stenosis to receive either their own iliac crest bone, or enriched mesenchymal stem cells from bone marrow. The mesenchymal stem cells were enriched and spun, which researchers found greatly increased the concentration of stem cells. They concluded the enriched mesenchymal stem cells are "a good bone substitute in posterior spinal fusion."

Nick Shamie, MD, president of the American College of Spine Surgery and an associate professor at UCLA, said he used a similar method in patients and has had "numerous" examples of success. In one case, Shamie treated a young woman who was suffering from painful vertebra slippage for 12 years. He used her own stem cells to fuse her spine, and two-and-a-half months after surgery she is pain-free, he told MedPage Today.

However, there is some concern about what happens to cells when they are concentrated.

Bryon Petersen, PhD, a stem cell researcher at Wake Forest Baptist Medical Center, in Winston-Salem, N.C., said that culturing cells in a lab for a long period of time could potentially have a "deleterious" effect on the cells and transform them into potentially cancer-causing cells. Those cells must be carefully weeded out before being injected into a patient, he said in an email to MedPage Today and ABC News.

However, he added that the idea of using one's own stem cells to cure an ailment -- "self healing self" as he phrased it -- is a "very real possibility" and a "technology that the United States should actively be pursuing."

While Shamie and Peterson expressed excitement about stem cell spinal fusion, other experts contacted by ABC News/MedPage Today said the procedure is untested and not ready to be marketed to the American public.

George Daley, MD, PhD, a professor of biological chemistry and molecular pharmacology at Harvard Medical School, pointed to the dearth of evidence on the value of injecting mesenchymal stem cells, and said he worries that the procedure is being done based on anecdotes or observational trials.

"I suspect that what is going on here is part of the world-wide rush to commercialize stem cells prematurely, to capitalize on the hype and [make] a buck, long before the treatments have been proven safe and effective," Daley said in an email.

Richard Fessler, MD, professor of neurological surgery at Northwestern University's Feinberg School of Medicine, echoed Daley's sentiments.

"Although this is a promising technology for the future, at this point there is minimal evidence that it is effective in humans," he said in an email.

Jonathan Moreno, MD, professor of biomedical ethics at the University of Pennsylvania, was harsher in his assessment:

"The medical claims being made for this 'treatment' are nonsense," he said, also in an email.

Moreno dismissed the science of the procedure, but said the political ramifications of the Perry situation are especially interesting: "Namely, how talk of a stem cell industry in Texas would cause anxiety among cultural conservatives that such an effort could involve more controversial forms of research, like embryonic stem cells," he said.

Adult stem cells are not the same as embryonic stem cells. Perry -- and many conservatives -- oppose using cells from human embryos for research.

Daley pointed to another political issue: A governor using his power to promote a procedure that hasn't been proven.

"It's sad when someone in such a powerful position like the governor of a major state can act without the benefit of evidence-based medicine," he said.

Still, others like Peterson are waiting to see how the new technology evolves.

"It will be interesting to see just what happens in this case and hopefully many more cases to come," he said.

This article was developed in collaboration with ABC News.
 

Connie

New member
another article

I love all the press this is getting. It is going to get harder and harder to keep these treatments from "we the people" when our leaders are getting and benefiting from them. In the past Perry has not had my support in part because of he appeared to be in bed with big pharma when he tried to make the HPV vaccine mandatory for all teenaged girls. But I am quite pleased with him for standing up for Adult Stem Cells. Here is yet another article.

http://officechairsdetails.info/perry-allies-lay-groundwork-for-tx-stem-cell-industry-texas-tribune/


Over the last 2 months, Rick Perry, a state representative with numerous sclerosis and the spinal column surgery doctor who carried out the governor’s July One mature stem cell infusion have been laying the foundation for the commercialization of the disputable practice in Texas.

In the month before Dr. Stanley Jones injected Perry with his personal laboratory-grown stem cells in a spinal fusion — created to speed recovery of the probable presidential hopeful’s back trauma — lawmakers passed a medical care bill that calmly approved making of a state mature stem cell bank. That alteration was added, with input from the governor’s office, by Rep. Rick Hardcastle, R-Vernon, who has MS and states he’s about to start getting stem cell infusions from Jones as part of a new human being trial.

And in the weeks since Perry’s stem cell infusion, the Texas Medical Board has held a stakeholder meeting — mainly at the governor’s and Jones’ direction — to talk about how to control the practice in Texas. It’s pretty clear where Perry stands: 2 days before last seven days’s Medical Board meeting, Perry sent a letter to the board chair espousing the economic and life-changing potential of mature stem cells and asking members to understand “the sound science and great work that is already being done” as they consider new regulations.

Injecting patients with their personal stem cells is a hotly debated practice: While some doctors promise by the practice’s healing properties, other ones contend it has little medical indication of success. The practice has sparked a nationwide dispute over where physicians’ medical autonomy ends and FDA regulation commences.

Central to the dispute in Texas is Jones, a Houston orthopedic surgery doctor and individual companion of both Perry’s and Hardcastle’s who believes he was healed of exhausting arthritis by having an infusion of his personal stem cells in Japan. Jones is working, together with a Korean corporation supreme recognized for cloning puppies and promotion “stem cell cosmetics,” to start the mature stem cell business in Texas.

A commencing point can be a stem cell bank. The alteration Hardcastle stuck onto an omnibus medical care bill in June’s specific session approves the state’s healthiness and human being services commissioner to set up an “autologous” mature stem cell bank — meaning a place for patients to shop their personal stem cells for future use.

Hardcastle said the governor’s office didn’t ask him to take it — as the only member of the Legislature with MS, he said, it’s been on his mind for “a long time” — though one of the governor’s staffers did recommend him on it. Something implicated, Hardcastle said, was Jones, who has already eliminated several of Hardcastle’s stem cells to prepare them for re-injection.

A spokeswoman with the Healthiness and Human Being Services Commission said the organization is in the pretty early stages of considering if to make the stem cell bank. Several weeks ago, the organization obtained a letter from Houston Reps. Beverly Woolley, a Republican, and Senfronia Thompson, a Democrat, expressing their “serious concern” with the measure, for worry it could obstruct the work of community and personal academics.

Meantime, Texas Medical Board spokeswoman Leigh Hopper said the regulatory organization held a stem cell stakeholder meeting last seven days — “at the governor’s behest, through Dr. Jones” — to start dialogue about mature stem cell treatments in Texas. The question? If US Citizens are — like Jones — more and more flying all through the the planet to get promising stem cell treatments, shouldn’t Texas be a scientific and economic center for it?

Perry wrote as much in a letter he sent to Texas Medical Board president Irvin Zeitler Jr., 2 days before the stakeholder meeting, and 3 weeks after his personal infusion.

“It is my wish that Texas will end up being the planet’s leader in the study and use of mature stem cells,” he wrote.
 

Kaye

New member
Connie

"Meantime, Texas Medical Board spokeswoman Leigh Hopper said the regulatory organization held a stem cell stakeholder meeting last seven days — “at the governor’s behest, through Dr. Jones” — to start dialogue about mature stem cell treatments in Texas. The question? If US Citizens are — like Jones — more and more flying all through the the planet to get promising stem cell treatments, shouldn’t Texas be a scientific and economic center for it?"

That sounds promising. In case any Pioneer wants to contact them regarding their feelings on adult stem cell treatments in the US or on stem cell tourism, here's the contact info:


http://www.tmb.state.tx.us/

Customer Service E-mail verifcic@tmb.state.tx.us
Customer Service: (800) 248-4062 or (512) 305-7030 (outside Texas)
Customer Service Hours: Monday through Friday 8am-5pm
 

Teriss

New member
Thanks for posting that, I am going to do an article on it.

Can't stand his politics, but the idea that politicians are getting these treatments - is a good slant. I bet a lot of famous people are getting this done and we can spotlight that...the more support we get the better.

If you know of any other doctors, who are treating themselves or had ASC treatment please let me know....you can send a private message.
thanks very much,

Teri
 

barbara

Pioneer Founding member
Why the division?

It is very upsetting that this issue is so politicized. I am ecstatic that Governor Perry is moving forward and I would be just as ecstatic if embryonic research started producing dramatic results in humans rather than mice as well. It is almost as if many simply do not want those of us that are seriously and terminally ill or in pain to be able to try to do something to improve or extend our lives. I doubt that Governor Perry himself would have hopped on board to this extent if he hadn't have experienced stem cell therapy. Now that he has, I hope he goes full speed ahead with making stem cell therapy a reality for everyone that can potentially benefit from it.



Texas Gov. Perry supports adult stem cells after undergoing procedure
By Howard Lovy


Texas Gov. and possible GOP presidential contender Rick Perry got everybody talking about stem cells again when he announced that he received an injection of his own stem cells during spinal fusion surgery last month. He was quick to point out the obvious--that his own stem cells are not of the embryonic variety, which he vehemently opposes using on religious grounds. There are three main angles to this story: Political, economic and, of course, medical.

First, the political: Natasha Lennard puts it best in the last paragraph of her story in Salon: "Perry's adult stem cell success story will no doubt serve as a useful weapon in the highly politicized fight against" embryonic stem cell research. Those who oppose ESC research argue that breakthroughs in induced pluripotent stem cells, derived from adults, make ESC unnecessary. Most medical experts say that the two are not mutually exclusive and there are still many hurdles to overcome before iPS stem cells can make it to prime time. Then, the economic: Perry, along with his friend, Dr. Stanley Jones, who performed the governor's surgery, have been working with another lawmaker to create an adult stem cell bank in Texas. Perry's procedure gave the effort just the kind of public relations push it needed. Last month, Perry wrote a letter to the Texas Medical Board, which is considering new rules regarding adult stem cells, saying that he hoped the state would "become the world's leader in the research and use of adult stem cells," according to a report in the Texas Tribune.

Last, the medical: The procedure undergone by Perry is experimental, not approved by the FDA and, according to some medical experts, may only have a placebo effect. MedPage Today was one of the few publications covering the issue that at least hazarded a guess as to what exactly was done to the governor. Experts not involved in the procedure guessed that Perry had his own mesenchymal stem cells concentrated in a lab and then re-injected onto a scaffold device implanted in the spine. "The procedure is similar to spinal fusion surgery using a piece of bone harvested from the patient's own iliac crest to fuse two or more vertebrae," MedPage Today reports.
 

barbara

Pioneer Founding member
http://www.texastribune.org/texas-people/rick-perry/perrys-surgery-included-experimental-stem-cell-the/comments/

Perry's Surgery Included Experimental Stem Cell Therapy
by Emily Ramshaw 8/3/2011

When Gov. Rick Perry emerged from back surgery on July 1, he tweeted that his “little procedure” — a spinal fusion and nerve decompression designed to treat a recurring injury — had gone “as advertised.”

The possible presidential contender didn’t reveal that he’d undergone an experimental injection of his own stem cells, a therapy that isn’t FDA approved, has mixed evidence of success and can cost upwards of tens of thousands of dollars.

The governor’s procedure did not involve embryonic stem cells, which he and many other conservatives ardently oppose using for medical research on both religious and moral grounds. His treatment involved removing his own adult stem cells from healthy tissue and injecting them back into his body at the time of surgery, with the belief that the cells would assist tissue regeneration and speed recovery.

In a statement on Wednesday, Perry spokesman Mark Miner called the procedure “successful” and confirmed that it included “the innovative use of his own adult stem cells.”

While some doctors and biomedical engineers swear by the benefits of this relatively new science and offer the therapy to patients with everything from slipped discs to cardiac disease, stem cell experts say there’s still little clinical evidence — aside from research on animals and small-scale human studies — that it’s effective.


The FDA, which is in litigation over its authority to regulate new stem cell clinics, has not approved the use of adult stem cells for anything other than bone marrow transplants, which have been used for decades to treat cancer and sickle cell anemia patients. This has largely kept doctors from openly advertising these stem cell injections, but not from capitalizing on them by offering the therapy to their patients.

It also hasn’t stopped Perry from pushing for adult stem cell research and industry in Texas. During the governor’s 2009 State of the State address, he called on state leaders to invest in adult stem cell companies. Later that year, his Emerging Technology Fund awarded a $5 million grant to the Texas A&M Health Science Center Institute of Regenerative Medicine and $2.5 million to Helotes-based America Stem Cell to develop new adult stem cell technology.

Last month, three weeks after his adult stem cell treatment, Perry wrote a letter to the Texas Medical Board, which is considering new rules regarding adult stem cells, saying that he hoped Texas would “become the world’s leader in the research and use of adult stem cells.” He asked board members to “recognize the revolutionary potential that adult stem cell research and therapies have on our nation’s health, quality of life and economy.”

In the weeks since the procedure, the governor has traded his cowboy boots for orthopedic shoes and donned a back brace, raising questions that his recovery may be slow-going. Still, he has traveled extensively; in an interview with The Associated Press last week, Perry said he felt 80 percent recovered and was swimming and using the treadmill.

As for the high cost of such stem cell injections, Miner said that whatever state health insurance didn’t pay for, “Perry did.” By rule, the state's Employees Retirement System would not confirm or deny whether Perry is on the health plan. But officials said the state health plan does not cover experimental treatments like such stem cell therapy.

In Perry's procedure, his doctor, Houston orthopedic spine surgeon Stanley Jones, said he pulled stem cells from fatty tissue in the governor's hip, left the cells to expand in culture for several weeks at a Sugar Land lab, then injected the cells back into the governor during his back surgery, into the spine and into Perry's blood stream.

In May 2010, Jones made a high-profile trip to Kyoto, Japan, to get infused with his own stem cells to treat autoimmune arthritis. A January press release from RNL BIO, the South Korea-based stem cell company that treated him, reported that he had a complete recovery within five months.

The infusion of adult stem cells to repair tissue and organ damage is highly controversial. For every Bartolo Colon, the New York Yankees pitcher whose near-miraculous comeback is being attributed to the procedure, researchers say there are botched jobs and patients who spend tens of thousands of dollars with no results.

The biomedical engineers and spinal clinics developing stem cell products and performing the procedure say they’re seeing terrific results.

“They have been outstanding given how new the field is,” said Kevin Dunworth, founder and CEO of Austin-based Celling Technologies and SpineSmith, which prepares the adult stem cells for about 450 procedures in the U.S. every month, a quarter of them in Texas. “The added value of stem cells is that they’re wonderful at mitigating pain on a long-term basis, and they do it quite rapidly, within three to five days.”

But researchers say that despite the great potential adult stem cells may have, so far they’ve seen nothing more definitive than the so-called “placebo effect” — patients who convince themselves they’re feeling better simply by nature of having had the procedure. In some lab tests, stem cells that have been effectively deprogrammed to help regenerate a particular organ have appeared to turn cancerous. In others, patients have traveled around the world, spending $10,000 to $50,000 for stem cells that simply die off, with no effect on health.

“Most of this stuff is pretty experimental at this point,” said Heather Rooke, the science director for the International Society for Stem Cell Research. “People are pushing these things into the clinic before there’s real evidence of safety or an indication that they’ll work.”
 

Kaye

New member
The South Korean company

http://thecaucus.blogs.nytimes.com/2011/08/04/rick-perry-has-stem-cell-procedure-then-works-to-bring-it-to-texas/

August 4, 2011, 7:24 pm Rick Perry Has Stem Cell Procedure, Then Works to Bring it to Texas

By SARAH MASLIN NIR

Gov. Rick Perry of Texas, a potential Republican presidential candidate, has for the past two months been working toward laying the groundwork for the commercialization of adult stem cell therapy, a highly controversial treatment which Mr. Perry underwent a month ago.

According to the story first reported by the Texas Tribune, in the month before Mr. Perry’s procedure, which was performed by Dr. Stanley Jones, a Houston-based orthopedist and a personal friend of the governor, a healthcare bill that authorized the creation of an adult stem cell bank was passed by Texas lawmakers.

And in the weeks since Perry’s stem cell infusion, the Texas Medical Board has held a stakeholder meeting — largely at the governor’s and Jones’ direction — to discuss how to regulate the procedure in Texas.

In addition:

Two days before last week’s Medical Board meeting, Perry sent a letter to the board chair espousing the economic and life-altering potential of adult stem cells and asking members to recognize “the sound science and good work that is already being done” as they consider new regulations.

On July 1, after having undergone the back procedure, Mr. Perry posted on Twitter that it “went as advertised,” the Texas Tribune reported.

Little procedure went as advertised. Blessed to be married to the world’s best nurse. Thanks for all the prayers!!
Sat Jul 2 0:55:19 via Twitter for BlackBerry®
Rick Perry
GovernorPerry
But according to the Tribune,

The possible presidential contender didn’t reveal that he’d undergone an experimental injection of his own stem cells, a therapy that isn’t FDA approved, has mixed evidence of success and can cost upwards of tens of thousands of dollars.

Dr. Jones, the Tribune reported, had never before performed the procedure.

But last year, Dr. Jones and his wife traveled to South Korea and Japan to obtain the same treatment for their own ailments. Dr. Jones told the Tribune his recovery led him to contact Mr. Perry. “I told him, I’m in Korea seeing miracles, and something needs to be done for our fellow Americans.”

The South Korean company that cultured Dr. Jones’ stem cells has since opened an affiliated lab outside of Houston. Mr. Perry’s stem cells were cultured in that Texas-based lab.
 

barbara

Pioneer Founding member
Kaye, The article you just posted fails to take into consideration that the patient and the doctor both have experienced success with the therapy. Also, what is FDA approved?
The FDA may not need to "approve" this therapy. It depends on what it is. Here is some information on RNL/BIO from the ICMS website. There are risks to stem cell therapy as evidenced by the second patient's death that ICMS investigated. In this case, it is doubtful that it could have been something foreseen in any way. However, some companies are simply skating past safety concerns in their quest for the dollar and that is something to always be aware of. I have great hopes that Dr. Jones, Governor Perry, the Texas Medical Board and others will put safety at the forefront and do some serious clinicals and tracking of patients. If they follow guidelines for each and every patient, then it will minimize poor outcomes. Companies that don't do this are taking great risks with our lives. I hope that good news is forthcoming about Dr Jones' lab and his future plans for treating patients.


Here is the info from the ICMS website:
PORTLAND, OREGON, FEBRUARY 21, 2011 – Today, the International Cellular Medicine Society (ICMS) announced the conclusions from its investigation into the medical practices of RNLBio, and published the requirements for the South Korean company to come into compliance with ICMS Guidelines. The ICMS, a global nonprofit organization committed to advancing the field of cell based medicine through patient safety, physician education, and peer oversight, undertook this investigation after completing its adjudication of two patient deaths reported at clinics associated RNLBio in November, 2010.

The ICMS concluded its adjudication of the two deaths in December, 2010, and announced its findings at a press conference at the National Press Club in Seoul, South Korea. “In the course of the investigation,” said Dr Michael Freeman, PhD, MPH who led the adjudication for the ICMS, “The ICMS uncovered several issues about the practices of RNLBio. We felt it was essential that these issues be addressed.” Key concerns for the ICMS were the areas of informed consent and patient candidacy where RNLBio was significantly out of compliance with the ICMS’s published standards.

In response to these findings, the ICMS has developed a series of measures that will allow RNLBio to move back into compliance with the Society’s guidelines and international standards for the practice of medicine. The published report, available at the ICMS website, sets out a series of requirements for RNLBio. Among these requirements are that RNLBio immediately present itself for formal accreditation by the ICMS, the creation of an Ethics Oversight Group, the implantation of a patient management program for the collection and tracking of patient medical history and outcomes and submitting to a full audit by the ICMS within 90 days of the publication of these findings. “Our goal is to provide RNLBio with a pathway back to compliance,” said David Audley, executive director of the ICMS. “These conclusions require a significant alternation of RNLBio’s medical and business practices,” continued Audley, “But by putting patient safety first and embracing transparency and oversight, RNL has an opportunity to become an international leader in cell based medicine.”

Feb212011
Findings and Recommendations from the Investigation of RNLBio

In October of 2010, the International Cellular Medicine Society (ICMS) learned of the deaths of two patients who received medical treatments using adult autologous stem cells (A-ASCs) harvested and banked by RNLBio, a company focused on development and commercialization of adult stem cell therapeutics based in Seoul, Korea. The two patients had received intravenous stem cell infusions using the patients’ own fat- derived stem cells for generalized “anti-aging” therapy in Japan and China.

RNLBio participates in the ICMS Treatment Registry, a web-based database that tracks safety and outcomes of patients that have received A-ASCs. RNLBio offers cell based medical treatment for a number of indications, ranging from anti-aging to autoimmune hearing loss. The ICMS has contracted with RNLBio to provide proactive tracking of patient reported outcomes for three conditions that comply with the ICMS criteria for Registry participation (critical limb ischemia, osteoarthritis and Parkinson’s disease).

While the two patients above were not ICMS Patient Registry participants, the cell processing and other procedures involved are common to all RNLBio patients. When the ICMS was made aware of reports of the patient deaths the Society had an obligation to carry out an investigation into the cause of death of the patients and to examine RNLBio’s treatment practices. ICMS sought and obtained RNLBio’s cooperation in investigating the causes of the deaths and potential interrelationships between RNLBio practices and the patients’ deaths. ICMS initiated its investigation of RNL Bio on November 11, 2010. The resulting adjudication provided these findings:

The death of patient 1, which occurred nearly 2 months after his last stem cell infusion, was unlikely to have been caused by either the stem cells or the procedures used to administer the stem cells. The specific cause of Patient 1’s death is currently unknown as no documentation has been released with this information.

The death of patient 2, which occurred on the same day as the stem cell procedure, was likely to have been caused or triggered by the stem cell procedure. The cause of death was due to a pre-existing blood clot that traveled to the lungs, and may have been precipitated by the procedure used to infuse the stem cells, or less probably, from a clot formed by the cells.

The complete findings of the forensic and ethics investigations have been posted previously on the ICMS website and are available for review.

Upon review of these findings, the ICMS notes critical compliance issues and makes recommendations to RNL Bio:

I. Findings as to Compliance with ICMS Guidelines

The ICMS finds that RNLBio and/or its partners are engaged in practices that are not consistent with the Clinical Guidelines of ICMS. The specific ICMS guidelines relevant to this case are:

ICMS Clinical Guidelines, Chapter 2, Section A: A physician must conduct comprehensive assessment of the patient prior to donation which includes:
History and physical examination specific to the problem being considered for treatment
Assessment of general health status and ability of the patient to participate safely in the A-ASC therapy
Discussion with the patient concerning the risks and benefits of the planned A-ASC procedure
ICMS Clinical Guidelines, Chapter 2, Section C: The ICMS considers the following to be basic tenets of clinical translation:
All research protocols using investigational cell lines should be approved by an Institutional Review Board.
ICMS takes no position on how research is funded and due to the dire need for treatment options for patients approves the use of “pay for trial” type research.
A blinded standard is not necessary. However, there should be measurement of both clinical outcomes and objective imaging or other objective changes.
ICMS Clinical Guidelines, Chapter 2, Section J: The physician should use very effort to prospectively grade each A-ASC therapy candidate into candidate categories, such as Good, Fair, or Poor. While scientific data on candidacy grading may or may not be available, oftentimes pragmatic grading systems can be used until such data becomes available. This grading should therefore take into account:
Objective indications of disease severity: For example, a patient who has more severe disease may be less likely to respond than a patient with mild disease.
Co-morbid conditions: For example, a cardiac treatment may be less effective in a patient with significant co-morbidity such as COPD, type I diabetes mellitus, and PVD.
Patient history: For example, a patient with a history of severe osteoporosis may be less likely to respond to a fracture healing application.
Prior physician experience with response rates: For example, the physician may have experience that a cosmetic application is less likely to be effective in patients over 80 years of age.
Contraindications: For example, the patient may have a history of active malignancy.
Factors that may reduce outcome: For example, the patient may be taking medications that negatively impact A-ASC yields.
While RNLBio appears to be out of compliance with ICMS Guidelines referenced above, of greater concern is the question of whether RNLBio is practicing medicine or engaging in the processing, banking, and provision of cells to treatment clinics. Under Korean law, RNLBio cannot engage the implantation of stem cells unless done under the auspices of Korean Food and Drug Administration (KFDA)-approved clinical trials. With the exception of these clinical trials, RNLBio does not itself, and legally cannot provide infusion of cells in South Korea. To provide treatments, RNLBio instructs patients to arrange a visitation to affiliated medical organizations in China and in Japan. It is within these clinics that patients receive treatments of their own A-ASCs that have been obtained and processed by RNLBio. This interruption in the oversight of the cells and outsourcing of treatment to third party clinics appears to lie outside of the establish norms of the practice of medicine.

II. Compliance Requirements for RNLBio

The International Cellular Medicine Society formally demands that RNLBio implement the following compliance requirements for all patients receiving treatments with cells harvested, processed, banked and provided by RNL Bio in accordance with ICMS Standards and Guidelines:

Initiate the process of formal clinic accreditation established by the ICMS within 30 days.
Demonstrate compliance with the best practice guidelines established by the ICMS, including, but not limited to:
Development and universal use of an institutional review board approved informed consent for enrollment in any clinical trial or treatment using A-ASC’s.
Universal use of ICMS patient candidacy evaluation procedures,
Pre-operative evaluation of all patients seeking treatment.
Initiate comprehensive program for the management of patient records, including the collection and tracking of patient medical history and outcomes.
Develop an Ethics Oversight Group to assess the quality of informed consent given to patients.
Provide proof that RNLBio Patient Coordinators, ‘Codi’s, act solely in the capacity of patient coordinators, and thus engage with patients only within a system in which all potential patients who indicate that they seek to utilize their cells are examined by medical doctors prior to banking of any cells or extraction of any material for banking.
Provide Patient Coordinators with annual training and that such training should include bioethics as well as an examination as to competency.
Submit itself to a full and complete audit by the ICMS of its practices and the adoption of these recommendations within 90 days of the publication of these findings.
Institute a process to ensure that all procedures that utilize cells harvested and/or processed by RNLBio are delivered to patients in accordance with ICMS guidelines and establish an indemnification clause in RNLBio contracts to delineate the ethical and legal responsibility of each party in delivery of these cells in accordance with ICMS guidelines.
Come into compliance with international standards for the practice of medicine by maintaining the one-on-one relationship between physician and patient.
Over the next 90 days, the ICMS will evaluate the practices of RNLBio and provide RNLBio with guidance on how to enter into compliance with ICMS guidelines. Should RNLBio fail to comply with the above guidelines and recommendations within 90 days, the ICMS will be forced to terminate RNLBio’s participation in the ICMS Treatment Registry and suspend its membership within the Society.
 

Kaye

New member
Barbara,

Agree. Also, notice that Dr. Jones and his wife both had treatment. One of the other articles had mentioned her "vascular" condition.

I thought the last 2 paragraphs were the most important:

"But last year, Dr. Jones and his wife traveled to South Korea and Japan to obtain the same treatment for their own ailments. Dr. Jones told the Tribune his recovery led him to contact Mr. Perry. “I told him, I’m in Korea seeing miracles, and something needs to be done for our fellow Americans.”

The South Korean company that cultured Dr. Jones’ stem cells has since opened an affiliated lab outside of Houston. Mr. Perry’s stem cells were cultured in that Texas-based lab."
 

barbara

Pioneer Founding member
I have to say I like Dr. Jones' vision and thoughtfulness. It is also good news for America that he evidently has political connections and the funds to get something moving. We've been waiting too long.
 

rickwheeler

New member
Hi Barbara, i'm not sure i understand how this clinic is able to culture cells when Dr. Centeno has been forced to cease doing that. I had a consultation today with their office regarding some back ailments i have.Rick
 
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