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Category Archives: Stem Cell Therapy
CIRM Contracting: $1.3 Million for IT, $887,282 for Legal
Posted: February 19, 2012 at 4:57 pm
The California stem cell agency this week performed its semi-annual public disclosure of its contracts with outside firms, the second largest item in its operational budget of $18.5 million.
The contracts are scheduled to run about $3.3 million this fiscal year, according to the budget approved last May. That figure is up about 18 percent from the previous year.
According to the contract information posted this week, the two largest contracting expenditures this year are for information technology work, including the ongoing struggles with the grants management system – $1.3 million – and legal help – $887,282. The figures were compiled by the California Stem Cell Report. CIRM did not provide totals.
Outside contracts are second to the cost of salaries and benefits at the agency. One reason for the size of the contracting expense is the small size of the CIRM staff, which is now about 50.
The contracting information will be presented to the CIRM directors' Governance Subcommittee next Friday. The committee is being asked to approve an increase in the contract with Kutir Corp., from $250,000 to $470,000. By the end of 2011, CIRM had already paid out $219,680 to Kutir. The firm provides software development services.
Infonetica, which provides technology advice, would also see an increase from $236,060 to $300,000, under the staff proposal.
A staff memo to the board said,
"(Kutir's) services are key as CIRM continues to progress in automating its grants management systems to meet the requirements of both new RFAs as well as ongoing reporting obligations.""
The public can participate in the Governance meeting at locations in San Francisco, Sacramento, Irvine, Los Angeles, South San Francisco and La Jolla. Specific addresses can be found on the agenda.
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Stem Cell Agency on Bee Article and Voter Expectations
Posted: February 19, 2012 at 4:57 pm
The California stem cell agency today said the seven-year-old "audacious vision" of voters when they created the $3 billion research effort "is still possible."
The comment was made in an item on the agency's blog by Amy Adams, the agency's communications manager.
Her entry point was an opinion piece in The Sacramento Bee on Sunday exploring some of the ins and outs of the agency. Among other things, CIRM President Alan Trounson was quoted by writer David Lesher as "optimistically" predicting successful California stem cell treatments in five years.
Adams wrote,
"Lesher makes clear that there are many challenges ahead in bringing new therapies to patients: he said of the voters who created CIRM, 'It was pretty audacious of them in 2004 to try to create another economic driver like Silicon Valley and save lives at the same time.'
"And while the vote was audacious, we agree with his conclusion that despite risks and challenges that vision is still possible."
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Blue-Ribbon Panel Seeks Public Comment on California Stem Cell Agency
Posted: February 19, 2012 at 4:57 pm
The California public is being given a chance to weigh in with anonymous comments about what they think of the performance of the $3 billion California stem cell agency.
Their opinions are being sought by a blue-ribbon, Institute of Medicine panel. The IOM is being paid $700,000 by the agency to examine its operations.
The questions include the importance of stem cell research and CIRM's role, its openness and transparency, an assessment of its grant programs and how it should share information with the public, suggestions for improvements and more.
The online form was posted recently on the IOM web site and can be found here. The deadline for submissions is March 19.
The IOM also has survey forms for academic and non-profit CIRM grant recipients, CIRM grant recipients that are businesses(which the IOM calls "industry partners") and "leadership of CIRM-funded institutions." The deadline for those is March 19 as well.
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World Stem Cells, LLC. Stem Cell Treatments In Cancun at Advanced Cellular Medicine Clinic
Posted: February 17, 2012 at 8:16 am
World Stem Cells, LLC Stem Cell Therapy at a state of the art clinic in beautiful Cancun. The clinic is staffed by top specialist in the field of stem cell implants and a new laboratory to support the stem cell treatments given.
(PRWEB) February 16, 2012
World Stem Cells, LLC. contract laboratory Advanced Cellular Engineering Lab (Ingenieria Celular Advanzada S.A. de C.V.) a new adult stem cell laboratory being built in Cancun, Mexico to support Stem Cell research, stem cell clinical trials and stem cell treatments. This was accomplished by private funding in conjunction with World Stem Cells, LLC worldstemcells.com a US patient management company, Medicina Biocelular Avanzada , S.E. de C.V. a Mexican patient management company and Advanced Cellular Medicine Clinic of Cancun, a Stem Cell treatment Clinic owned and operated by Dr. Sylvia M. Abblitt a well known board certified hematologist and oncologist, in Cancun.
Uniquely, Dr. Abblitt is one of a limited number of physicians licensed to perform autologous and allogeneic stem cell transplants. Dr. Abblitt has been utilizing stem cell therapies with successes for many years.
She is the president and lab director of Advanced Cellular Engineering Lab (Ingenieria Celular Advanzada S.A. de C.V.). Her extensive background includes having been the laboratory director and head of hematology for Hospital Fernando Quiroz for 11 years. As a pioneer in the stem cell transplant field, she brings a vast array of knowledge to the lab. Her memberships include the american association of blood banks (aabb), Mexican society of transfusional medicine, interamerica society of transfusional medicine, Mexican association) for studies of hematologyandicms and ICMS (international cellular medical society and all patients are monitored by ICMS an independent agency for a period of between 2-20 years on a quarterly basis. Dr. abblitt has had a 26-year clinical practice history.
The laboratory construction is complete and operations were transferred to our new facility. This facility provides Cancun, and patient around the world, a state of the art GLP laboratory to support their stem cell treatments in a beautiful, and positive environment. The lab was designed and constructed to provide one ISO7 lab, one wet lab along with a treatment area. This will allow stem cell retrieval, testing, culturing, selection, counting, analyses and sorting along with cryopreservation, without removal from the lab. This all in house capability reduces the possibility of contamination and errors. Dr. M. Abblitt will operate the Lab under cGMP/cGLP guidelines and use the state of the art facility to provide quality care to her stem cell transplant patients.
Working under the guidelines set forth by ICMS world stem cells, LLC ( http://worldstemcells.com/ ) provides stem cell treatment for ankylosing spondylitis, autism, cerebral palsy, charcot-marie-tooth disease (cmt), crohn’s diseases, copd, fuch’s disease, guillain-barre’ syndrome, hashimoto’s thryroiditis, itp, kidney diseases, macular degeneration, lupus (sle), multiple sclerosis, pad, parkinson’s disease, rheumatoid arthritis, scleroderma, stroke, ulcerative colitis
The laboratory will be engaged in private clinical trials, IRB’s and joint studies with US companies, Mexican Educational Institutes, US universities and doctors to better understand the benefits and precaution to be taken in the stem cell treatment process.
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World Stem Cells, LLC. Stem Cell Treatments In Cancun at Advanced Cellular Medicine Clinic
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Stem cell study in mice offers hope for treating heart attack patients
Posted: February 16, 2012 at 4:21 am
ScienceDaily (Feb. 15, 2012) — A UCSF stem cell study conducted in mice suggests a novel strategy for treating damaged cardiac tissue in patients following a heart attack. The approach potentially could improve cardiac function, minimize scar size, lead to the development of new blood vessels -- and avoid the risk of tissue rejection.
In the investigation, reported online in the journal PLoS ONE, the researchers isolated and characterized a novel type of cardiac stem cell from the heart tissue of middle-aged mice following a heart attack.
Then, in one experiment, they placed the cells in the culture dish and showed they had the ability to differentiate into cardiomyocytes, or "beating heart cells," as well as endothelial cells and smooth muscle cells, all of which make up the heart.
In another, they made copies, or "clones," of the cells and engrafted them in the tissue of other mice of the same genetic background who also had experienced heart attacks. The cells induced angiogenesis, or blood vessel growth, or differentiated, or specialized, into endothelial and smooth muscle cells, improving cardiac function.
"These findings are very exciting," said first author Jianqin Ye, PhD, MD, senior scientist at UCSF's Translational Cardiac Stem Cell Program. First, "we showed that we can isolate these cells from the heart of middle-aged animals, even after a heart attack." Second, he said, "we determined that we can return these cells to the animals to induce repair."
Importantly, the stem cells were identified and isolated in all four chambers of the heart, potentially making it possible to isolate them from patients' hearts by doing right ventricular biopsies, said Ye. This procedure is "the safest way of obtaining cells from the heart of live patients, and is relatively easy to perform," he said.
"The finding extends the current knowledge in the field of native cardiac progenitor cell therapy," said senior author Yerem Yeghiazarians, MD, director of UCSF's Translational Cardiac Stem Cell Program and an associate professor at the UCSF Division of Cardiology. "Most of the previous research has focused on a different subset of cardiac progenitor cells. These novel cardiac precursor cells appear to have great therapeutic potential."
The hope, he said, is that patients who have severe heart failure after a heart attack or have cardiomyopathy would be able to be treated with their own cardiac stem cells to improve the overall health and function of the heart. Because the cells would have come from the patients, themselves, there would be no concern of cell rejection after therapy.
The cells, known as Sca-1+ stem enriched in Islet (Isl-1) expressing cardiac precursors, play a major role in cardiac development. Until now, most of the research has focused on a different subset of cardiac progenitor, or early stage, cells known as, c-kit cells.
The Sca-1+ cells, like the c-kit cells, are located within a larger clump of cells called cardiospheres.
The UCSF researchers used special culture techniques and isolated Sca-1+ cells enriched in the Isl-1expressing cells, which are believed to be instrumental in the heart's development. Since Isl-1 is expressed in the cell nucleus, it has been difficult to isolate them but the new technique enriches for this cell population.
The findings suggest a potential treatment strategy, said Yeghiazarians. "Heart disease, including heart attack and heart failure, is the number one killer in advanced countries. It would be a huge advance if we could decrease repeat hospitalizations, improve the quality of life and increase survival." More studies are being planned to address these issues in the future.
An estimated 785,000 Americans will have a new heart attack this year, and 470,000 who will have a recurrent attack. Heart disease remains the number one killer in the United States, accounting for one out of every three deaths, according to the American Heart Association.
Medical costs of cardiovascular disease are projected to triple from $272.5 billion to $818.1 billion between now and 2030, according to a report published in the journal Circulation.
First author Ye, Henry Shih, Richard E. Sievers, Yan Zhang, and Megha Prasad are with the UCSF Division of Cardiology; Yeghiazarians and Andrew Boyle are with the UCSF Division of Cardiology and the UCSF Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research; William Grossman is with the UCSF Division of Cardiology and the UCSF Cardiovascular Research Institute; Harold S. Bernstein is with the UCSF Cardiovascular Research Institute, the UCSF Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research, and the UCSF Department of Pediatrics; Hua Su is with UCSF Department of Anesthesia and Perioperative Care; and Yan Zhou with the UCSF Department of Cell and Tissue Biology.
The study was supported by funds from the Wayne and Gladys Valley Foundation, the UCSF Cardiac Stem Cell Fund and the Harold Castle Foundation.
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The above story is reprinted from materials provided by University of California, San Francisco (UCSF), via Newswise. The original article was written by Leland Kim.
Note: Materials may be edited for content and length. For further information, please contact the source cited above.
Journal Reference:
Jianqin Ye, Andrew Boyle, Henry Shih, Richard E. Sievers, Yan Zhang, Megha Prasad, Hua Su, Yan Zhou, William Grossman, Harold S. Bernstein, Yerem Yeghiazarians. Sca-1 Cardiosphere-Derived Cells Are Enriched for Isl1-Expressing Cardiac Precursors and Improve Cardiac Function after Myocardial Injury. PLoS ONE, 2012; 7 (1): e30329 DOI: 10.1371/journal.pone.0030329
Note: If no author is given, the source is cited instead.
Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.
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Stem cell study in mice offers hope for treating heart attack patients
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Stem Cell Stocks: Mending Scarred Hearts
Posted: February 16, 2012 at 4:21 am
A new study at Johns Hopkins University has shown that stem cells from patients' own cardiac tissue can be used to heal scarred tissue after a heart attack. This is certainly exciting news considering heart failure is still the No. 1 cause of death in men and women.
The study included 25 heart attack victims, 17 of whom got the stem cell treatment. Those patients saw a 50% reduction in cardiac scar tissue after one year, while the eight control patients saw no improvement.
The procedure involves removing a tiny portion of heart tissue through a needle, cultivating the stem cells from that tissue, and reinserting them in a second minimally invasive procedure, according to Bloomberg.
"If we can regenerate the whole heart, then the patient would be completely normal," said Eduardo Marban, director of Cedars-Sinai Heart Institute who was the study's lead author. "We haven't fulfilled that yet, but we've gotten rid of half of the injury, and that's a good start."
Business section: Investing ideas
Interested in investing in the promise that stem cell therapy holds? For a look at the investing landscape, we compiled a list of the 10 largest companies involved in stem cell therapy.
Do you think this industry will see growth from stem cell research? (Click here to access free, interactive tools to analyze these ideas.)
1. BioTime (NYSE: BTX ) : Focuses on regenerative medicine and blood plasma volume expanders. Market cap at $291.95M. The company develops and markets research products in the field of stem cells and regenerative medicine. It develops therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases; cardiovascular and blood diseases; therapeutic applications of stem cells to treat orthopedic diseases, injuries, and cancer; and retinal cell product for use in the treatment of age-related macular degeneration.
2. Cleveland BioLabs (Nasdaq: CBLI ) : Market cap at $111.50M. Its products include Protectan CBLB502, a radioprotectant molecule with multiple medical and defense applications for reducing injury from acute stresses, such as radiation and chemotherapy by mobilizing various natural cell protecting mechanisms, including inhibition of apoptosis, reduction of oxidative damage, and induction of factors that induce protection and regeneration of stem cells in bone marrow and the intestines, and Protectan CBLB612, a modified lipopeptide mycoplasma that acts as a stimulator and mobilizer of hematopoietic stem cells to peripheral blood, providing hematopoietic recovery during chemotherapy and during donor preparation for bone marrow transplantation.
3. Gentium: Focuses on the development and manufacture of its primary product candidate, defibrotide, an investigational drug based on a mixture of single-stranded and double-stranded DNA extracted from pig intestines. Market cap at $128.29M. The company develops defibrotide for the treatment and prevention of hepatic veno-occlusive disease (VOD), a condition that occurs when veins in the liver are blocked as a result of cancer treatments, such as chemotherapy or radiation, that are administered prior to stem cell transplantation.
4. Geron (Nasdaq: GERN ) : Develops biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure, and diabetes. Market cap at $265.57M. The company has licensing agreement with the University Campus Suffolk to develop human embryonic stem cell-derived chondrocytes for the treatment of cartilage damage and joint disease.
5. Harvard Bioscience: Develops, manufactures, and markets apparatus and scientific instruments used in life science research in pharmaceutical and biotechnology companies, universities, and government laboratories in the United States and internationally. Market cap at $118.28M. Develops devices used by clinicians and researchers in the field of regenerative medicine, including bioreactors for growing tissue and organs outside the body, and injectors for stem cell therapy.
6. Lydall (NYSE: LDL ) : Designs and manufactures specialty engineered products for thermal/acoustical, filtration/separation, and bio/medical applications in the United States. Market cap at $163.44M. In addition, it offers Cell-Freeze, a medical device used for cryogenic storage of peripheral blood stem cells.
8. Osiris Therapeutics (Nasdaq: OSIR ) : Focuses on the development and marketing of therapeutic products to treat various medical conditions in the inflammatory, autoimmune, orthopedic, and cardiovascular areas. Market cap at $157.26M. A stem cell company, focuses on the development and marketing of therapeutic products to treat various medical conditions in the inflammatory, autoimmune, orthopedic, and cardiovascular areas.
7. Verastem: Market cap at $229.00M. Focuses on discovering and developing proprietary small molecule drugs targeting cancer stem cells (CSCs) in breast and other cancers.
Interactive Chart: Press Play to compare changes in analyst ratings over the last two years for the stocks mentioned above. Analyst ratings sourced from Zacks Investment Research.
Kapitall's Alexander Crawford does not own any of the shares mentioned above.
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Stem Cell Stocks: Mending Scarred Hearts
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First local dogs receive ‘amazing’ stem-cell therapy
Posted: February 15, 2012 at 1:05 pm
Just before 10 a.m. Tuesday, Jake — a hobbling, 12-year-old yellow Labrador retriever — went into surgery at the Stanley Veterinary Clinic in Overland Park with crippling arthritis, no longer able to run without pain or even walk down stairs.
He had already been on months of medications that seemed to turn the normally happy dog sad. And hip and joint replacements costing tens of thousands of dollars were not feasible, said owners Mike and Elizabeth LeBlanc of Leawood.Still, their 8-year-old daughter, Mia, had just one request at Christmas. “All I want is for Jake to feel better,” she wrote.So, on Tuesday morning, Jake became one of the first canines in the Kansas City area to undergo a somewhat new and controversial procedure in which stem cells were harvested from the fat of his own body and then injected into his joints. The expectation is that within a few weeks the cells will regenerate missing cartilage and turn his arthritic joints healthy again.“It’s amazing,” said veterinarian Les E. Pelfrey, who conducted the procedure. “A few weeks later, these guys are running up and down.”The stem-cell procedure, which has gained notice in recent years with anecdotal stories of success on YouTube and cable television, remains controversial not only for its quick adoption in veterinary clinics nationwide, but also because some researchers say it remains scientifically unproven and expensive, at $1,800 or more per treatment.“Let me tell you one thing,” said James L. Cook, a professor of orthopedics at the University of Missouri’s College of Veterinary Medicine. “I don’t want to write off stem cells. Stem cells may hold the key for truly restorative medicine.”In horses, stems cells have been shown to help rejuvenate damaged tendons and other problems. They are being tested for cardiac problems.“But in the joints for dogs with arthritis? No way,” Cook said. “I would never recommend anyone get this done.”Stem cells essentially are the equivalent of young and impressionable cells whose genetic gears have yet to determine their fate. Because they are so young, they theoretically can turn into any kind of cell, from cartilage to neurons. In humans, stem cells have long been held out as possible therapy for diseases such as Parkinson’s.The problem, Cook said, is that although a few studies have shown that the injection of stem cells into arthritic canine joints does reduce pain, compared with “control” dogs not injected with stems cells, no studies have convincingly shown that stems cells are any better at helping dogs than the current, and less expensive, standard of care. That typically involves a combination of weight loss, pain medications and, when necessary, injections of hyaluronic acid, a slippery substance that often goes missing in arthritis. Those injections, given a couple of times a year, cost less than $100 each.Moreover, even if the stem cells work, no one knows at this point how long the improvement will persist, although some vets have noted benefits lasting a year or more.“We know for sure that it (stem cell injections) does have some palliative effects. It can make symptoms better,” Cook said. “And we do know for sure that it does not regenerate cartilage in arthritic joints. The palliative effects are not as good, or no better, than hyaluronic acid injections.”That is far from the case being made by companies now promoting stem-cell therapy in dogs, or owners who believe in it.A number of stem-cell companies have emerged in recent years. Chief among them are Vet-Stem, based in Poway, Calif., and MediVet America, a division of MediVet, based in Sydney, Australia, which notes that it is currently conducting studies on canines, stem cells and cartilage regeneration.Both use largely similar technologies and methods. At the vet’s office, the dog undergoes a quick procedure in which a bolus of fat about the size of a golf ball is taken from above the shoulder.The fat is processed and treated with chemicals to extract millions of stem cells. Some of those cells are then injected into a dog’s damaged joints; the rest enter the body through an intravenous line into the bloodstream.One prime difference between the Vet-Stem and MediVet systems is that Vet-Stem costs about $3,000 or more.Vet-Stem requires the veterinarian to ship the fat sample to California, where it is processed and sent back for injection. Several dogs in the Kansas City area have been injected with stem cells from Vet-Stem.The MediVet system costs pet owners about $1,800. It provides veterinarians with a kit to process the stem cells in their own offices over about four hours. Dogs are injected with stems cells on the same day the fat is removed. The pet typically goes home the next day.In Topeka, the University Bird and Small Animal Clinic has used the MediVet kit and system with what it says are positive results on about 40 dogs since November 2010. A veterinarian there, Larry Snyder, helped train Pelfrey in Overland Park.Snyder came to the clinic two weeks ago to perform the procedure on another hobbled yellow Labrador retriever, Milo, owned by dentist Jon Finley and his wife, Sharon, in Leawood.“Dr. Pelfrey and Mrs. Finley didn’t tell me how much this procedure was going to cost,” Jon Finley said, “and I’d rather you not tell me. No matter what, he’s walking better, standing upright, feeling better. I can’t help but think he’s going to get better and better.”Jake’s owner said that, whatever the outcome, she knows that the procedure is not a cure.“I’m hoping this gives him a better quality of life,” Elizabeth LeBlanc said. “I got him when he was just 6 weeks old. He was such a blessing. It will be worth it, even if I can give him one more great summer.”
To reach Eric Adler, call 816-234-4431 or send email to eadler@kcstar.com.
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Bone gives 'some' heart healing
Posted: February 15, 2012 at 1:04 pm
14 February 2012 Last updated at 19:10 ET By James Gallagher Health and science reporter, BBC News
Bone marrow stem cell therapy offers "moderate improvement" to heart attack patients, according to a large UK review of clinical trials.
The analysis by the Cochrane Collaboration looked at 33 trials involving more than 1,700 patients.
It said longer-term studies were needed to see if the experimental therapy affected life expectancy.
The review comes a day after doctors reported the first case of using heart cells to heal heart attack damage.
If a patient survives a heart attack, dead heart muscle is replaced with scar tissue - leaving the patient weaker and possibly on a lifetime of medicine.
Researchers are beginning to show that taking cells from a heart, growing millions of new heart cells in the laboratory and pumping those back into the heart may reduce scar tissue and lead to new heart muscle.
Continue reading the main story “Start Quote
Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far”
End Quote Dr Enca Martin-Rendon Lead researcher
However, the trials are at a very early stage and in only a handful of patients. Using a similar technique with cells taken from the bone marrow, which is a prime source of stem cells, has a much longer pedigree.
The report by Cochrane pooled the data from all 33 bone marrow trials which had taken place up to 2011.
It concluded that bone marrow therapy "may lead to a moderate long-term improvement" in heart function which "might be clinically very important".
Longer life uncertain
It said there was still no evidence of "any significant effect on mortality" in comparison with standard treatment. However, this may be due to the size of the studies and that patients were followed for a short period of time.
Lead author Dr Enca Martin-Rendon, from NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, said: "This new treatment may lead to moderate improvement in heart function over standard treatments.
"Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."
Prof Anthony Mathur, from Barts and the London School of Medicine and Dentistry, is leading the largest ever trial of stem cells in heart attack patients.
It starts this year, however, he told the BBC that the results could come quite quickly. Three thousand patients across Europe will take part. They will be injected with stem cells five days after a heart attack and then followed for two years to see if the therapy affects life expectancy.
Prof Peter Weissberg, medical director at the British Heart Foundation, said: "This review reflects the consensus of opinion about these trials - cell therapy has a modestly beneficial effect.
"Despite that, no-one knows why, or even if, cell therapies will translate into better survival or sustained improvement in damaged hearts. It's much too early to judge the likely long-term benefits."
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Bone gives 'some' heart healing
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Stem cell treatments improve heart function after heart attack
Posted: February 15, 2012 at 1:17 am
Public release date: 14-Feb-2012
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Contact: Jennifer Beal
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Wiley-Blackwell
Stem cell therapy moderately improves heart function after a heart attack, according to a systematic review published in The Cochrane Library. But the researchers behind the review say larger clinical trials are needed to establish whether this benefit translates to a longer life.
In a heart attack, the blood supply to parts of the heart is cut off by a blocked artery, causing damage to the heart tissue. The cells in the affected area start to die. This is called necrosis and in the days and weeks that follow, the necrotic area may grow, eventually leaving a large part of the heart unable to contract and increasing the risk of further heart problems. Stem cell therapy uses cells from the patient's own bone marrow to try to repair and reduce this damage. Currently, the treatment is only available in facilities with links to scientific research.
The authors of the review drew together all the available evidence to ask whether adult bone marrow stem cells can effectively prevent and repair the damage caused by a heart attack. In 2008, a Cochrane review of 13 stem cell therapy clinical trials addressed the same question, but the new review adds 20 more recent trials, drawing its conclusions from all 33. By incorporating longer follow up, the later trials provide a better indication of the effects of the therapy several years after treatment.
The total number of patients involved in trials was 1,765. All had already undergone angioplasty, a conventional treatment that uses a balloon to open the blocked artery and reintroduce the blood supply. The review's findings suggest that stem cell therapy using bone marrow-derived stem cells (BMSCs) can produce a moderate long-term improvement in heart function, which is sustained for up to five years. However, there was not enough data to reach firm conclusions about improvements in survival rates.
"This new treatment may lead to moderate improvement in heart function over standard treatments," said lead author of the study, Enca Martin-Rendon, of the Stem Cell Research laboratory, NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, UK. "Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."
It is still too early to formulate guidelines for standard practice, according to the review. The authors say further work is required to establish standard methods, including cell dosage, timing of cell transplantation and methods to measure heart function. "The studies were hard to compare because they used so many different methods," said Martin-Rendon. "Larger trials with standardised treatment procedures would help us to know whether this treatment is really effective.
Recently, the task force of the European Society of Cardiology for Stem Cells and Cardiac Repair received funding from the European Union Seventh Framework Programme for Research and Innovation (EU FP7-BAMI) to start such a trial. Principal Investigator for the BAMI trial, and co-author of this Cochrane review, Anthony Mathur, said, ''The BAMI trial will be the largest stem cell therapy trial in patients who have suffered heart attacks and will test whether this treatment prolongs the life of these patients."
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Stem cell treatments improve heart function after heart attack
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Scarred Hearts Can Be Mended With Stem Cell Therapy
Posted: February 15, 2012 at 1:17 am
February 14, 2012, 3:17 PM EST
By Ryan Flinn
(Adds comment from researcher in 13th paragraph.)
Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.
In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.
“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”
The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.
“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”
Minimally Invasive
The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.
A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.
While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.
Heart Regeneration
“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”
While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.
“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.
The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Linda Marban, is also a founder and chief executive officer.
“We’d like to study patients who are much sicker and see if we can actually spare them early death, or the need for a heart transplant, or a device,” Eduardo Marban said.
--Editors: Angela Zimm, Andrew Pollack
#<184845.409373.2.1.99.7.25># -0- Feb/14/2012 17:13 GMT
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Posted in Cell Therapy, Stem Cell Therapy
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