Costa Rica shuts stem cell clinic (CellMedicine)

danny

New member
http://news.yahoo.com/s/nm/20100602/sc_nm/us_costarica_stemcells_1



MEXICO CITY (Reuters) ? Costa Rica has ordered the country's largest stem cell clinic to stop offering treatment, saying there is no proof that it is effective, the country's health minister said on Wednesday.

About 400 patients, mostly foreigners from the United States, have been treated at the Institute of Cellular Medicine in San Jose for multiple sclerosis, arthritis, spinal injuries and other illnesses.

"This isn't allowed in any serious country in the world," Health Minister Maria Luisa Avila said in a telephone interview.

The Health Ministry several weeks ago ordered the clinic, owned by Arizona entrepreneur Neil Riordan, to stop performing the treatment, in which stem cells extracted from the patients are reinjected into their bodies.

The ministry said the clinic has a permit to store the stem cells extracted from patients' own fat tissue, bone marrow and donated umbilical cords but is not authorized to perform the treatment.

Sylvia Molina, an assistant at the clinic, said it would shut its doors on Friday.

Neither Riordan nor the clinic's medical director, Fabio Solano, were immediately available for comment.

Riordan's team uses adult stem cells, which can be found throughout the body.

These master cells of the body give rise to many different tissues and blood cells and are standard treatments for leukemia and a few other genetic diseases.

They are different from embryonic stem cells, taken from human embryos. But Riordan's treatment approach is considered experimental by most experts and the International Society of Stem Cell research has warned against so-called stem cell tourism.

Doctors at Riordan's clinic have said that they have seen excellent results from the procedure, but ministry officials said that there is no proof that the treatments work.

The stem cell treatments at the Costa Rica institute cost between $5,000 and $30,000.

China, Thailand and Mexico also offer stem cell treatments, but Costa Rica's stability, modern tourism infrastructure and proximity to the United States had made it a preferred destination for many patients.

Riordan has a U.S. company called Aidan Products that sells, among other things, a nutritional supplement that his team says can stimulate the body's production of blood stem cells.

He also operates a stem cell clinic in Panama and is chairman of Arizona-based Medistem Inc.
 

barbara

Pioneer Founding member
I learned of this last week. It is another good reason for doctors to start doing more clinicals to back up their claims of efficacy. Dr. Riordan has published some of his work in peer reviewed journals, but obviously it wasn't enough to convince the new administration. He will continue to treat patients in Panama.
Costa Rica has a new President and we will just have to see how much this will affect the country's medical tourism. My concerns are that this is once again a control and power issue, not one that has a lot to do with patients and treatment efficacy. The ISSCR is hell bent to have a global FDA. They have Big Pharma ties and that makes for a whole different ballgame.
 

Kaye

New member
Entest and Medistem

Barbara and Danny,

I ran across this article this week. Wonder if the closure will make a difference to Entest regarding contemplated acquition? I was hoping that they would go forward with the plans that involved the low level laser treatment for COPD. I think I read they planned to use a drug already approved by FDA (Mozobil) that mobilizes stem cells from the bone marrow to the blood stream and then can intice them to the lungs with the laser? Anybody know anything? I'm still so hopeful that the amount of information coming out now about treatment will help us - not hurt us. I was really disappointed that Bioheart chose Jordon and Turkey but not surprised.

SOURCE: Entest BioMedical, Inc.

May 12, 2010 08:00 ETEntest BioMedical Updates Status of Proposed Medistem Transaction, Discusses Potential Revenue Streams
Entest CEO States Due Diligence Process in Full Swing on Potential Medistem Inc. Transaction; Contemplated Acquisition May Provide Near Term Revenue
SAN DIEGO, CA--(Marketwire - May 12, 2010) - Entest BioMedical, Inc. (OTCBB: ENTB) announced commencement of due diligence in preparation of the proposed acquisition of Medistem, Inc. The due diligence process includes examination of Medistem's intellectual properties, company financials and key business relationships. On April 5, 2010, Entest Biomedical entered into a Letter of Intent ("LOI") regarding the contemplated acquisition of approximately 61% of Medistem.

Medistem has a portfolio of products in various stages of development covered by 15 families of patent applications and has filed an Investigational New Drug (IND) Application with the FDA for use of its Endometrial Regenerative Cells for the treatment of critical limb ischemia, a form of peripheral artery disease. Medistem's Endometrial Regenerative Cell (ERC) is a "universal donor" stem cell that is capable of differentiating into heart, bone, muscle, blood vessel, lung, brain, liver, and islet cells.

David Koos, Chairman & CEO of Entest BioMedical, stated, "We are currently reviewing Medistem's operations as part of our due diligence. Both Dr. Thomas Ichim, CEO of Medistem, and myself have been studying how Medistem's intellectual properties may dovetail into Entest's treatment models and are both extremely excited about the prospects of a combined entity . We believe that Medistem's ERC stem cells could become an important component of Entest's therapeutic treatment for Chronic Obstructive Pulmonary Disease (COPD). The ERC appears to facilitate the regeneration of blood vessels, a critical factor in curing COPD. We look forward to working jointly towards cures for COPD, Critical Limb Ischemia and an Immunotherapeutic cancer vaccine for animals."

A spokesperson for Entest noted that the contemplated acquisition has the potential to generate a term revenue stream as a result of reagent sales of Medistem's ERC stem cell. Entest anticipates being able to market 2,000 units of the ERC stem cell reagents within 12 months of this transaction at $500 per unit.

The proposed acquisition contemplated by the LOI is subject to the parties entering into a definitive agreement and the satisfaction of the terms and conditions of that agreement.

About Entest BioMedical Inc.:

Entest BioMedical Inc. (OTCBB: ENTB) is involved with the development of stem cell therapy treatments for Chronic Obstructive Pulmonary Disease (COPD), immuno-cancer therapies, testing procedures for diabetes, stem cell research applications for diabetes and other illnesses. The Company also is involved with medical device development (including stem cell extraction instrumentation). ENT-576? is a proprietary laser device currently under development by Entest. The Company has filed 4 patent applications relating to the treatment of COPD. Entest BioMedical Inc. is a majority owned subsidiary of Bio-Matrix Scientific Group Inc. (OTCBB: BMSN). Recently Entest announced publication of its platform technology in the peer-reviewed Journal of Translational Medicine which is available at http://www.translational-medicine.com/content/8/1/16. For additional information on Entest, go to the Company's website: www.entestbio.com or its blog site: www.entestbioblog.com.
 

barbara

Pioneer Founding member
I contacted Tom Ichim, CEO of Medistem. He said that ICM was doing the majority of their work in Panama which I guess didn't set well with the new minister of health in Costa Rica. Ahhhhhhhhh, I love politics - NOT. Again, in my opinion, this really has nothing to do with the efficacy of stem cell therapy.

As I mentioned, Dr Riordan and Tom Ichim have a lot of published data. I can think of nothing worse than a global FDA to stifle medical innovation around the world, but that is what they are pushing. The ISSCR would prefer that most of us drop dead waiting for treatment to become FDA approved in the U.S. Of course this treatment would require some kind of lifetime drug that would need to be taken. Costa Rican officials evidently didn't bother to ask any patients or read Dr. Riordan's papers, but took it upon themselves to declare themselves some kind of experts in the field. They probably also were pressured by the ISSCR. Their loss.
 
Weller/Nepsis/Biogenesis Institute in Costa Rica

Looks like the alliance with Mr. Costa Rica may have had a set back unless he can pull some strings.
 

barbara

Pioneer Founding member
From what I gathered, ICM has no interest in working in Costa Rica again. Evidently, Panama is the new Costa Rica.
 

pink7

New member
Cellmedicine

I have some friends who went to CR and had good benefits with the stem cell treatment. They liked CR as well to visit. Pity they are now closed. Too much politics !!
 
Medical Tourism

The Health Insurance Companies push into international Medical Tourism for dental, specialized surgeries and other mainstream medical treatments but at a lower cost than the USA must be a big enough cash business for the Costa Rican Government to suddenly step in and declare SCT a no no. I would certainly consider Germany a very 'serious country' and they allow SCT. It makes no sense except when one follows the money.
 

barbara

Pioneer Founding member
The ISSCR would like to shut down offshore clinics. Costa Rican officials have no clue if patients are being helped. Patients, caregivers, etc. must start posting when improvements are made in their lives because of stem cell therapy. I rail on about ICMS, but it is a group that is making a great effort to combat the negativity that the ISSCR produces. The ISSCR offers nothing for patients.

If we do not become a lot more active, a lot more verbal and a lot more responsive to negative press, we may find ourselves with nowhere to go for stem cell therapy. This is really critical. Big Pharma has a lot of money. A lot of money buys politicians, scientists, doctors, media and evidently now whole countries! Don't let this happen. It will turn stem cell therapy into an underground business which is a scary thought.

You say this can't happen? Well think again. It just did happen in Costa Rica.
 
I read the article.

Thank you for posting it. If The health ministry is closing down an embryonic stem cell therapy clinic, I am all for closing it and applaud their action. The use of adult stem autologous and placental/umbilical cord blood derived stem cells will probably not be affected.
David Snow
 

barbara

Pioneer Founding member
I have asked Dr. Riordan and Thomas Ichim for a comment. Until we hear more, then I do not feel that it is safe to presume that the press got it right. It seems odd that the first story said that they were allowed to store stem cells, but not to treat with them. There are conflicting reports on all of this, so I don't think it is wise to make a rush to judgment.

If the use of umbilical cord, placental and autologous stem cells were still going to be allowed, I doubt if ICM would close the doors as they were doing this type of treatment and a lot of them at that. If they were also doing embryonic stem cell treatment, then surely they would just have been asked to discontinue that if Costa Rica was still allowing the other types of stem cell therapy. I don't applaud any of this without having the full details of all involved and that may be impossible.
 

barbara

Pioneer Founding member
And yet another article -

Costa Rica puts brakes on popular stem cell tourism
Leslie Josephs
SAN JOSE
Mon Jun 7, 2010

Costa Rica shuts stem cell clinic
Wed, Jun 2 2010

Costa Rica (Reuters) - Costa Rica is cracking down on an unauthorized stem cell clinic that has attracted hundreds of foreigners seeking relief from degenerative diseases and serious injuries.

Better known for its idyllic tropical beaches and lush cloud forests, Costa Rica's many hospitals and clinics have made medical tourism one of the fastest growing segments of its tourism sector, the motor of its economy.

They lure tens of thousands of foreigners seeking surgery, dental work, cancer treatment, cosmetic surgery, and dozens of other procedures at a fraction of their cost in the United States.

Until this week, one of those draws was stem cell treatment, using master cells gleaned from umbilical cords, fat and elsewhere.

The health ministry last month ordered the country's largest stem cell clinic to stop offering treatments, arguing there is no evidence that the treatments work or are safe.

"If (stem cell treatment's) efficiency and safety has not been proven, we don't believe it should be used," said Dr. Ileana Herrera, chief of the ministry's research council. "As a health ministry, we must always protect the human being.

The clinic's owner, Arizona entrepreneur Neil Riordan, told Reuters he closed the clinic and admitted the treatments, involving the removal and re-injection of stem cells, had not been approved by the U.S. Food and Drug Administration.

"I think her point was that it is not FDA approved," he said in a telephone interview from Panama.

The ministry said the clinic had a permit to store the adult stem cells, extracted from patients' own fat tissue, bone marrow and donated umbilical cords, but is not authorized to perform the treatment.

OUTRAGED PATIENTS

Some of his patients were outraged that the clinic was forced to close.

"I think it's ridiculous, in all honesty," said Cranston Rodgers, a 67-year-old former billing materials salesman from Las Vegas, who received treatment from the clinic three years ago for an aggressive case of multiple sclerosis.

"I know what it did for me. I haven't used a cane or a scooter since I used the first treatment."

Since Riordan's Institute of Cellular Medicine opened in 2006, about 400 foreigners, mostly from the United States, have undergone the experimental treatment unavailable in North America and Europe to treat multiple sclerosis, spinal injuries, diabetes and other ailments.

Raul Montejo, a 48-year-old South Florida neurologist who was paralyzed from the waist down in October when he crashed into a telephone pole while driving home, said he got some feeling back in his leg after treatments.

"I'm not getting up and running, but I'm making very good progress," Montejo said in an interview at the clinic in April.

But other experts note that without controlled clinical trials, there is no way to know if the treatment is making such differences or some other factor, and worry that the clinic exploits ill patients' desperation with an unproven remedy.

The International Society of Stem Cell research has cautioned against so-called stem cell tourism.

"The (U.S.) clinical trials are ambiguous at the moment," said Dr. David Scadden, co-director of the Harvard Stem Cell Institute in Boston.

"When these kinds of treatments are proposed, they're being essentially marketed by virtue of the anecdotal report. I feel the danger of exploitation is extremely high."

MASTER CELLS

Riordan's team uses adult stem cells, which can be found throughout the body. These master cells give rise to many different tissues and blood cells and are standard treatments for leukemias and a few other genetic diseases.

They are different from embryonic stem cells, taken from human embryos. Costa Rica is heavily Roman Catholic and the use of embryonic stem cells, taken from human embryos, is prohibited.

While still in the clinical trial phase in the United States, researchers are working to use stem cells to treat heart disease, Parkinson's disease and other disorders.

But Riordan has not followed the careful procedures more common in a clinical trial, which involve checking patients given the treatment against patients who have a sham therapy to rule out the placebo effect.

Riordan, who spent years developing cancer vaccines in Arizona, but has never treated a patient with stem cells, calls the treatment groundbreaking.

"I've seen more medical firsts in the past four years than probably most people ever see in their lives," Riordan, who operates a larger clinic he plans to expand in neighboring Panama, said in an interview. "For me it's very exciting."

Riordan has a U.S. company called Aidan Products that sells, among other things, a nutritional supplement that his team says can stimulate the body's production of blood stem cells.

He is also chairman of Arizona-based Medistem Inc. a company that seeks to commercialize stem cell therapies, particularly with cells extracted from menstrual blood.

Even patients who have seen positive results refuse to classify Riordan's therapy as a miracle treatment.

Holly Huber, a 37-year-old business old business developer from San Diego, who was diagnosed with secondary progressive multiple sclerosis, said she began feeling her feet for the first time in a year three weeks after she was injected with stem cells harvested from abdominal fat.

"I'm not going to say it's 100 percent. That's not reasonable. But can I function? Yes," she said.

Huber said she had spent $300,000 on drug and holistic treatments in the United States with little result, and turned to the $30,000 stem cell treatment in Costa Rica.

"I didn't have anything to lose." she said.

(Editing by Maggie Fox and Kieran Murray)
 

barbara

Pioneer Founding member
Probably so and for the countries that missed it, the ISSCR will soon have it available on DVD.
 
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