Spain's pionering work

[carmen868]

For all those who may not have seen this:
SPAIN, IGNORING USELESS EMBRYONICS, LEADS THE WORLD IN STEM CELL ORGAN TRANSPLANTS
Working with Minnesota?s Dr. Doris Taylor, the western world?s only true stem cell pioneer, it is now possible to rescue organs from the trash heap and make them suitable for transplant.


Madrid---Nov 1, 2010 Twelve years ago, Dr. Doris Taylor proved to a disbelieving world, through a landmark animal study at Duke University, that Adult Stem Cells (ASC) could repair the hearts of dying patients. Within an astonishing four years, clinical trials around the world proved her right for humans.

But then Pharma, in 2003, realized how much ASC could destroy its strangle-hold on western medicine, and created the ?Embryonic Hoax? as a vehicle to keep ASC away from the millions who could use them today. Controlling with its purse-strings the majority of stem cell scientists, almost every academic institution, and certainly most of the West?s major media, the hoax became ?true? as the Big Lie of the 21st century, and North America became a hopeless cause for stem cells which actually help people.

But that did not deter Spain?s Dr. Fern?ndez Avil?s from his goal, which only Dr. Taylor could make possible in such a short time; and today the collaboration is ready to begin working its magic:
Take a donor organ which cannot help the patient.
?Empty? that organ of its original stem cells.
Replace those with the patient?s ASC, and
In a few months it is ready for transplant without cancer-causing immune-suppressing drugs which every transplant demands today.

Not bad for a heart or a liver or a kidney otherwise destined for the hazardous waste heap of the hospital!

Spain, a world leader in human organ transplants, is now also THE pioneer in the creation of bioartificial organs with stem cells implanted into patients after the opening on Tuesday in Madrid of the first laboratory in the world dedicated to the growth of artificial organs for human transplant. The laboratory will "empty" human hearts or other human organs unsuitable for transplantation and recolonize their cell content with the patient's stem cells, allowing the organs to grow anew, ready for transplant back into the new body, said its developer,Dr. Francisco Fern?ndez Avil?s, head of the Gregorio Maranon hospital cardiology wing, where the center is based. The lab, opened this Tuesday, is the "world's first laboratory for bioartificial organs to produce adult stem cell transplants," said the Minister of Science and Innovation, Cristina Garmendia. The creation of artificial organs is a "third way" that is added to human organ transplantation and implantation of artificial organs, said Rafael Matesanz, director of the National Transplant Organization (ONT).

Transplantation of such organs could become a daily reality in "between five and ten years" according to Dr Fern?ndez Avil?s, "and is the solution to two problems." One is the lack of suitable organ donors and the other the "rejection" of the transplanted organ by the patient, because the freshly "grown" organs are inert and "have no immune response capability with less than 5% of original DNA" he said.

The aim of the laboratory is "to create a parent bank, in which organs can be stored for months, on which new bodies can be built to suit individual patients.? The bodies or "matrixes" which are emptied cannot be directly used for transplants because the deceased donor "either died from a cardiac arrest or old age" according Matesanz and this is a way of using organs that would otherwise not be used.

The opening of the laboratory has been possible thanks to the work of the Gregorio Mara??n in transplantation and regenerative medicine and its collaboration with the ONT and the University of Minnesota (USA) and director of cardiac repair, Dr. Doris Taylor, who has investigated the procedure using the hearts of mice.

So far, the cardiology unit of the Gregorio Mara??n has "applied the elimination of cells" to eight hearts that have successfully become viable organs using the patient's stem cells.

And by late 2010 they want to install a heart from a donor using regenerated cells. Moreover, "as it advances, the arrays could arise not only from humans but using animal organs" said Dr. Fern?ndez Avil?s.

The implementation of the laboratory- in which the hospital has invested 600,000 euros and where ten people will work, is also based on Spain's leadership in organ donation and transplantation.

Spain is a world leader in organ donation for transplants since 1991 and has "the best model for transplant in the world", according to Fern?ndez Avil?s. In 2009, Spain made 4,028 donor transplants, a new record for the country.

Furthermore, Spain is part of the so called 'G-4' of regenerative medicine, along with the United States, Canada and the United Kingdom and is "among the ten powers higher quality biomedical world," according to the Minister for Science and Innovation.

Except the United States, Canada, and the United Kingdom are fully controlled by Big Pharma and wasting billions on something which is not needed and which will never work to improve human lives before 2050. Sort of like spending billions researching propeller-driven aircraft and ignoring jet engine science.

 

[Jeannine]

Except the United States, Canada, and the United Kingdom are fully controlled by Big Pharma and wasting billions on something which is not needed and which will never work to improve human lives before 2050. Sort of like spending billions researching propeller-driven aircraft and ignoring jet engine science.

Ain't that the truth! I saw an ad yesterday from the makers of Advair that said they had reached their goal of 1 million new users. What does that tell you?

 

[barbara]

The aim of the laboratory is "to create a parent bank, in which organs can be stored for months, on which new bodies can be built to suit individual patients.? The bodies or "matrixes" which are emptied cannot be directly used for transplants because the deceased donor "either died from a cardiac arrest or old age" according Matesanz and this is a way of using organs that would otherwise not be used.


This is the key to success as there simply aren't enough good donor organs available otherwise.



There is more to the story however:


http://www.medcitynews.com/2010/01/can-miromatrix-regenerate-minnesotas-medical-industry-an-exclusive-interview-with-dr-doris-taylor-and-miromatrix-ceo-rob-cohen/

Can Miromatrix ?regenerate? Minnesota?s medical industry? An exclusive interview with Dr. Doris Taylor and Miromatrix CEO Rob Cohen

Miromatrix CEO Robert Cohen and founder Dr. Doris Taylor

MINNEAPOLIS, Minnesota ? Miromatrix Inc. has one official employee, zero money and nothing yet to develop, never mind sell. But make no mistake: everyone wants a piece of it.

?The buzz around town is that this is hot technology,? said Mark Kroll, a medical device investor and a former top executive at St. Jude Medical Inc. ?All the right people are excited about this.?

Miromatrix is close to signing a licensing agreement with the University of Minnesota to commercialize the regenerative tissue work of Dr. Doris Taylor. Two years ago, the star university scientist drew international attention for successfully growing ? and keeping alive ? a beating rat?s heart in a jar. Taylor?s work fueled hopes that scientists can one day grow replacement organs for patients who would typically wait for transplants.

?This is the future,? said Miromatrix CEO Robert Cohen.

Both Cohen and Taylor sat down with MedCity News for their first interviews since the university spun out the company in December. (Miromatrix takes its name from Taylor?s favorite artist, Joan Miro i Ferra, a Spanish surrealist painter and sculptor.)

?The prospect of doing something with Dr. Taylor was more exciting than anything I?ve ever seen,? said Cohen, a veteran medical device and pharmaceutical executive. ?It?s a technology that everyone at the table knows can do great things.?

Said Taylor: ?Certainly, my dream is to make a difference and we can?t do that unless we move the technology to products.?

It?s difficult to overstate Miromatrix?s importance to Minnesota. If successful, some say the company could spark a biotechnology boom in Minnesota the same way Earl Baaken?s homemade pacemaker 40-plus years ago launched the state?s dominance in implantable heart devices, a mighty comparison Taylor and university and industry officials do little to dispel.

State leaders that once paid little attention to home grown start-ups are now scrambling to craft a package of financial incentives to ensure the company stays local. The school, which has traditionally struggled at technology transfer, has moved cautiously, hoping to avoid past mistakes that allowed game-changing technologies to skip town.

?The university used to have trouble promoting its technologies,? Kroll said. ?Now people are saying that the school is going too slow. People are complaining they didn?t get the (Miromatrix CEO) job.?

But hype doesn?t always translate into reality. With a few exceptions, biotech companies have yet to meet the lofty expectations of investors and patients. The technology is notoriously tricky and requires considerable time and money to meet strict federal regulatory requirements. Growing full-scale organs like hearts will take years, if not decades, to master.

?It?s exciting to see this moving forward but it?s also a little scary,? Taylor said. ?There?s a lot of science yet to be done.?

Take stem cells, which have excited scientists because of their ability to morph into cells that perform specialized functions, like instruct the heart to beat or the pancreas to produce insulin. But delivering stem cells to the right locations in the body, coaxing them into replacement tissue and ensuring they survive has proved extraordinarily difficult.

But Taylor says her technology solves those problems. In 2008, Taylor and her team successfully grew a rat?s heart in a jar by stripping the cells off a dead rat?s heart and then injecting cells from a live rat into the organ. In addition, Taylor designed a bioreactor that could successfully nurture the nascent heart with blood and oxygen in a sterile environment. An artificial womb, if you will.

More importantly, the technology creates matrix structures that can deliver the right number of cells to the injury, attract new cells and keep the cells alive so they develop into tissue and eventually organs. The patient?s body will more readily accept the new organs because they?re made from the patient?s own cells.

?The cells itself are not the whole solution,? Taylor said. ?You need an architect to direct where the cells go and tell them what to do. This is a long-term fix. The cells have to survive.?

?We have the tools to put stem cells into the body and determine what they will grow up to be,? she said. ?The technology may be complex but the idea is simple and that?s the beauty of it. We are not inventing a new science. The science already exists.?

But first thing?s first. Growing or repairing organs may be the ultimate goal but Miromatrix still needs to generate sales. CEO Cohen said the company will operate two businesses: one to develop the core technology and the other to sub-license Taylor?s work to other companies.

A first product Miromatrix would launch itself is biological cardiac patches that can repair diseased heart tissue. After a patient suffers a heart attack, scar tissue forms, forcing the organ to pump harder to compensate for the lower amount of healthy tissue. The resulting stress can cause heart failure.

Companies like Synovis Life Technologies Inc. in St. Paul are developing scaffolding made from biomaterials like cow tissue that can attract the body?s cells and blood vessels, allowing the body to remodel the tissue type. But Miromatrix?s obvious advantage is to avoid animal tissue altogether by using the patient?s cells to build the patches.

As for sub-licensing, Taylor envisions other biotech companies using her technology to develop skin grafts for burn victims that can grow hair or even sweat. Another application would be cosmetic products like breast reconstruction for breast cancer survivors.

Cohen says it makes to sub-license because ?this is a platform technology that can apply to so many efforts. If we tried to keep it all inside, it would take too long to develop, which is foolish because there is much expertise in the world.?

A larger question is whether Miromatrix will or even should coax Minnesota away from its core expertise of mechanical heart devices, an increasingly stagnant market, toward faster growing industries like biologics. Medtronic Inc., Boston Scientific Corp. and St. Jude Medical, all depend on cardiac devices for the majority of their revenue but are aggressively moving into new technologies like neurostimulation, orthopedics and diabetes treatments.


Cohen, a former vice president of business and technology development at St. Jude Medical, thinks biologics is key to the region?s future. He spent several years in top positions at Pfizer Hospital Products Group Inc. and Sulzer Medica before moving to the Twin Cities 11 years ago. After leaving St. Jude, Cohen became CEO of Travanti Pharma, which specialized in drug-delivery platforms that would ease potential side effects in patients. Teikoku Pharma Inc. of Japan purchased Travanti last year for an undisclosed sum.

?Implant devices only treat the symptoms,? Cohen said. ?They target only the healthy parts of the body but they don?t solve the underlying problems.?

But Minnesota has struggled to develop biotech companies, though the state has made major investments recently, including money for a $300 million bioresearch medical park at the university?s Minneapolis campus and a planned Elk Run Biotechnology Center outside of Rochester in southeastern Minnesota.

A successful breakthrough like Miromatrix is a necessary but not sufficient ingredient to create a sustainable biotech industry in Minnesota, said Ross Meisner, managing partner of Dymedex Consulting in St. Paul, which advises medical technology firms.

Unlike Baaken?s pacemaker, which he created in the 1960s, the world today is fraught with regulatory, financial and competitive pressures that will challenge Miromatrix, he said.

For one thing, Taylor is hardly the only scientist researching this field. From California and Wisconsin to North Carolina and Pennsylvania, universities are pouring millions of dollars into Institutes for Regenerative Medicine. The U.S. military has also invested heavily in this area.

For example, the Army Institute of Surgical Medicine is working with the University of Pittsburgh to develop a powder that can regrow limbs, muscles and burned skin. The Wake Forest Institute for Regenerative Medicine is working on a ?soup? of cells and nutrients that researchers paint onto a scaffolding in the shape of an organ. The structure is placed into an incubator and after six weeks, a new organ emerges.

Cohen expects Miromatrix to ink a licensing agreement in about three weeks. The company will then raise seed money of less than $1 million to begin operations. Asked whether Miromatrix will remain in Minnesota, Cohen was noncommittal.

?The company will be located where it will best be located,? Cohen said. ?If the state can help us, we will stay here.?

The state is reportedly preparing ?an economic development package? that could include a mix of tax credits, loans or grants.

?I intend to make this technology work,? Taylor said. ?Too much time has already been spent on this for it not to work.?

 

[Kaye]

Barbara

Has everybody gone insane? What ever happened to helping patients? This is greed at its worst. If they can use a person's cells to "make" an organ, why can't I use my own cells for healing. Or, maybe our families can sell our organs to the highest bidder - if the FDA doesn't confiscate them first. Will there be anything left for a funeral? The "greed" monster rears its ugly head again! Another thing, I am not a lab rat and the "scientists" need to leave the "practice of medicine" to the "doctor." Won't the FDA have to approve each and EVERY one of the rebuilt organs? After all, they own the "drugs" used to make the organ. Makes me want to rethink organ donation!