Public release date: 6-Nov-2012 [ | E-mail | Share ]

Contact: Steve Goodyear sgoodyear@mhif.org 952-807-8365 Minneapolis Heart Institute Foundation

MINNEAPOLIS, MN November 6, 2012 Administering autologous stem cells obtained from bone marrow either 3 or 7 days following a heart attack did not improve heart function six months later, reports a new clinical trial supported by the National Institutes of Health. The results of this trial, called TIME (Transplantation In Myocardial Infarction Evaluation), were presented by Jay Traverse, MD of the Minneapolis Heart Institute Foundation Tuesday, Nov. 6, at the 2012 Scientific Sessions of the American Heart Association in Los Angeles.

The results of this trial mirror a previous, related study (LateTIME) which found that autologous bone marrow stem cell therapy given 2-3 weeks after a heart attack did not improve cardiac recovery. Both TIME and LateTIME were carried out by the Cardiovascular Cell Therapy Research Network (CCTRN), sponsored by the NIH's National Heart, Lung, and Blood Institute.

"The data presented by TIME do much to advance stem cell therapy research," said Jay Traverse, MD of the Minneapolis Heart Institute Foundation and Principal Investigator of this study. "While this study did not provide a demonstrated cardiac benefit after six months, we still learned a great deal. Together, TIME and Late TIME have shown that stem cell therapy is safe, and they have set a baseline in terms of quantity of stem cells, type of stem cells, and severity of heart attack."

TIME enrolled 120 volunteers (avg. age 57) between July 2008 and February 2011; the participants all had moderate to severe impairment in their left ventricle and had undergone coronary stent placement as treatment for the heart attack. The participants were randomly assigned to one of four groups: day 3 stem cell, day 3 placebo (inactive cells), day 7 stem cell, or day 7 placebo. The CCTRN researchers developed a method of processing and purifying the stem cells from the bone marrow of each volunteer to ensure everyone received a uniform dose (150 million stem cells).

Heart improvement was assessed six months after stem cell therapy by measuring the percentage of blood that gets pumped out of the left ventricle during each contraction (left-ventricular ejection fraction, or LVEF). The study found no significant differences between the change in LVEF readings at the six month follow-up in either the Day 3 or Day 7 stem cell groups compared with placebo or with each other; every group showed about a 3 percent improvement in LVEF. However, the researchers found that younger patients randomized to Day 7 had greater improvement in their LVEF compared to their placebo counterparts

"The lack of six-month improvement seen for TIME and, prior to that, LateTIME, does not mean stem cell therapy is not a viable post-heart attack strategy," said Traverse. "Because we have this data we can start to address some parameters; for example this therapy may work better in younger people, or maybe we need to use cells from healthy volunteers (allogeneic) since their cells may provide greater therapeutic benefit. There will also be upcoming studies using novel cell types which we look forward to using in future clinical trials."

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Stem cell therapy using patient's own cells after heart attack does not enhance cardiac recovery

MANILA, Philippines -- The Department of Health (DOH) has announced its plan to regulate stem cell therapy in the country.

Stem cell treatment involves the use of adult stem cells to treat a range of diseases.

The Health Department believes that because of the complex preparation and invasive procedure involved, there needs to be a regulatory framework to protect Filipino citizens.

The regulation of laboratories and practitioners involves five key points.

First is a check on the credentials of people involved in the service, as stem cell treatment is a specialized field. The supply of raw materials will also have to be monitored, making sure especially that they do not come from aborted fetuses.

Laboratories will be scrutinized for their procedures, sanitation and safety. Therapeutic claims, on the other hand, are also up for strict assessment, to make sure that these are based on solid scientific evidence.

Finally, the DOH also wants a report on the possible failure of treatments, to find out if there are negative outcomes to stem cell therapy.

"Those who are going to other countries for stem cell treatment should also check if their destination allows stem cell tourism," clarified FDA Acting Director Dr. Kenneth Hartigan-Go.

The DOH said consultations with stakeholders are still ongoing, but it expects a set of guidelines to be released by next month.

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Stem cell therapy to be regulated in PH

Washington, November 7 (ANI): Stem cell therapy improves heart function in patients who had previous heart attacks, according to researchers from the University of Louisville and Brigham and Women's Hospital.

In a Late-Breaking Clinical Trial session at the American Heart Association Scientific Sessions 2012 meeting, Roberto Bolli, M.D., of the University of Louisville and Piero Anversa, M.D., of Brigham and Women's Hospital, Boston, presented data from their groundbreaking research in the use of autologous adult stem cells with patients who had previous heart attacks.

They report that after two years, all patients receiving the stem cell therapy show improvement in heart function, with an overall 12.9 absolute unit increase in left ventricular ejection fraction (LVEF), a standard measure of heart function that shows the amount of blood ejected from the left ventricle during a heartbeat.

No adverse effects resulting from the therapy were seen. Moreover, MRIs performed on nine patients in the trial showed evidence of myocardial regeneration - new heart tissue replacing former dead tissue killed by heart attack.

"The trial shows the feasibility of isolating and expanding autologous stem cells from virtually every patient," said Bolli, who is the Jewish Hospital Heart and Lung Institute Distinguished Chair in Cardiology and director of the Institute for Molecular Cardiology in the Department of Medicine at UofL.

"The results suggest that this therapy has a potent, beneficial effect on cardiac function that warrants further study," he stated.

The trial - called SCIPIO for Stem Cell Infusion in Patients with Ischemic CardiOmyopathy - was a randomized open-label trial of cardiac stem cells (CSCs) in patients who were diagnosed with heart failure following a myocardial infarction and had a LVEF of 40 percent or lower; the normal LVEF is 50 percent or higher.

The investigators harvested the CSCs, referred to as "c-kit positive" cells because they express the c-kit protein on their surface, from 33 patients during coronary artery bypass surgery. The stem cells were purified and processed in Anversa's lab in Boston so that they could multiply. Once an adequate number of stem cells was produced - about one million for each patient - Bolli's team in Louisville reintroduced them into the region of the patient's heart that had been scarred by the heart attack.

The researchers reported that in the 20 patients receiving CSCs, LVEF increased from 29 percent to 36 percent at four months following infusion. None of the 13 control patients in the trial received CSCs and this group showed, on average, no improvement.

The beneficial effect of the CSCs persisted and became progressively greater at the one- and two-year mark following infusion. At the one-year mark following infusion, LVEF increased by 8.1 percent, and at the two-year mark, by 12.9 percent.

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Stem cell therapy improves heart function 2 years after heart attack

April Flowers for redOrbit.com Your Universe Online

Conflicting studies were highlighted at this years American Heart Association Scientific Sessions meeting concerning stem cell therapy for heart attack patients.

The first study, from the University of Louisville and Brigham and Womens Hospital, reported holy grail results for a Phase I clinical trial: marked sustained improvement in all patients with zero adverse effects.

Roberto Bolli, M.D., of the University of Louisville and Piero Anversa, M.D., of Brigham and Womens Hospital presented data from their groundbreaking research in the use of autologous adult stem cells with patients who had previous heart attacks in a Late-Breaking Clinical Trial session.

The researchers report that all patients receiving the stem cell therapy showed improved heart function after two years, with an overall 12.9 absolute unit increase in left ventricular ejection fraction (LVEF). LVEF is a standard measure of heart function that shows the amount of blood ejected from the left ventricle during a heartbeat. They saw no adverse effects from the therapy. In fact, nine patients showed evidence of myocardial regeneration new tissue replacing formerly dead tissue killed by heart attack in MRI scans.

The trial shows the feasibility of isolating and expanding autologous stem cells from virtually every patient, said Bolli, who is the Jewish Hospital Heart and Lung Institute Distinguished Chair in Cardiology and director of the Institute for Molecular Cardiology in the Department of Medicine at UofL. The results suggest that this therapy has a potent, beneficial effect on cardiac function that warrants further study.

In all patients, cells with high regenerative reserve were obtained and employed therapeutically, said Anversa, professor of Anesthesia and Medicine at Brigham and Womens Hospital and Harvard Medical School. Our efforts to carefully characterize the phenotype and growth properties of the cardiac stem cells may have contributed to these initial positive results.

The Stem Cell Infusion in Patients with Ischemic CardiOmyopathy, or SCIPIO, trial was a randomized open-label trial of cardiac stem cells (CSCs) in patients who were diagnosed with heart failure following a myocardial infarction and had a LVEF of 40 percent or lower. A normal LVEF reading is 50 percent or higher.

The CSCs, referred to as c-kit positive cells because they express the c-kit protein on their surface, were harvested from 33 patients during coronary artery bypass surgery. The stem cells were then purified and processed so that they could multiply, and once an adequate number was produced about one million for each patient they were reintroduced into the region of the patients heart that suffered scarring during the heart attack.

At four months after infusion, the researchers report that LVEF increased from 29 percent to 36 percent for 200 patients. On average, the 13 control patients who did not receive a CSC infusion showed any improvement.

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Studies On Stem Cell Therapy After Heart Attack Show Mixed Results

UPDATE on Stem Cell Therapy

7 November 2012

The Department of Health (DOH) saw the necessity to cover regulations for Stem Cell therapy. Stem Cell therapy belongs to the category of Advanced Cell therapy which includes biologics and blood. Many countries around the world apply a risk-based approach to assess the quality, efficacy and safety of advanced cell therapy. In many countries, Stem Cell is considered an investigational intervention.

Stem Cell research employs both autologous (from same person) or allogenic (from another organism like animal or another human cell or tissue sample) method. Because there are many steps in the preparation of this lab and invasive procedure, there is therefore need to have a regulatory framework to protect Filipino citizens.

Important questions were asked: is there proof of concept in animal trials where stem cell can then be applied in humans? Is there a way to ensure quality and purity of the raw materials? How safe is the procedure? How many did not benefit from the procedure? If this were investigational procedure, how will human subjects be protected?

Sec. Enrique Ona convened a consultative working task force to provide recommendations on how to proceed in the early part of the year in response to queries and mushrooming of centers here and overseas. This led to the creation of a regulatory task force to oversee the appropriate steps that will ensure quality, efficacy and safety documentation of this intervention.

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UPDATE on Stem Cell Therapy 7 November 2012

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Washington, November 6 (ANI): Administering to patients stem cells derived from their own bone marrow either three or seven days after a heart attack is safe but does not improve heart function six months later, according to a clinical trial.

The results of the trial, called Transplantation In Myocardial Infarction Evaluation (TIME), mirror a previous, related study, LateTIME, which found that such cells (called autologous stem cells) given two to three weeks after a heart attack did not improve heart function.

Both TIME and LateTIME were conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), sponsored by the NIH's National Heart, Lung, and Blood Institute.

"This study was extremely valuable even though it did not provide a demonstrated health benefit after six months," said Sonia Skarlatos, Ph.D., deputy director of NHLBI's Division of Cardiovascular Sciences and member of the CCTRN.

"Heart stem cell therapy research is still in its infancy, and results from early trials have varied greatly due to differences in the numbers of stem cells injected, the delivery methods used, and the compositions of the study populations. With TIME and LateTIME, we have established both safety and baseline results in two large studies that followed the same procedures for growing and then administering stem cells. This standard will inform the next steps in research on the use of stem cells to repair damaged hearts," she stated.

Fellow CCTRN member Jay Travese, M.D., of the Minneapolis Heart Institute added, "With this baseline now set, we can start to adjust some of the components of the protocol to grow and administer stem cell to find cases where the procedure may improve function."

"For example, this therapy may work better in different population groups, or we might need to use new cell types or new methods of delivery," he noted.

Skarlatos said that another advantage of the TIME study is that CCTRN is storing samples of the stem cells taken from the participants. Investigators can examine the relationship between people who showed significant improvement during the study and the characteristics of their stem cells. Such a comparison may offer insights on the cell traits that are associated with clinical improvement.

The findings will be presented at the American Heart Association (AHA) 2012 Scientific Sessions in Los Angeles and will appear concurrently in the Journal of the American Medical Association. (ANI)

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Stem cell therapy may not improve recovery after heart attack

RIO DE JANEIRO--(BUSINESS WIRE)--

CryopraxisTM/CellPraxis aims to start patient recruitment for its Phase III Refractory Angina Cell Therapy Brazilian arm clinical trial by the end of 2012 or early 2013. The phase IIA/B clinical trial study was completed in December 2011. These trials involved the use of a proprietary autologous stem cell formulation (MonocellTM) indicated for neoangiogeneses.

Safety and efficacy of this product was evaluated in patients with refractory angina, a no option disease condition, characterized by severe chest pain for which there is no efficient treatment available, says the President of both Companies, Eduardo Cruz.

ReACT, MonocellTMs derived product, showed evidence of safety and efficacy in our initial clinical trials. All patients included in this trial were classified as Class IV Angina in CCSAC* (the most severe class of chest pain). In the first group of patients, whose data was published**, there was a progressive and sustained improvement in angina symptoms, with 87.5% of the patients completing the clinical trial with a CCSAC score of 0 or 1.

Angina symptom relief began as early as 3 months post procedure with continuing improvement through the 18th month, suggesting that angiogenesis began early, and that it kept evolving 18 months after the procedure. Objective evaluation of stress myocardium perfusion (scintigraphic analysis), after 1 year of follow-up, gave indications of complete myocardial reperfusion in 75% of the patients, says Dr. Nelson Hossne, Medical Director of CellPraxis. Our conclusion was ReACT's specific cell formulation, MonoCell, had a direct correlation to myocardial neoangiogeneses.

About CryopraxisTM (www.cryopraxis.com.br) and CellPraxis (www.cellpraxis.com)

Located at Bio-Rio Biotech Cluster (Rio de Janeiro, Brazil), CryopraxisTM is the pioneer and the largest bank of umbilical cord blood in Brazil and has been in operation since 2001, with approximately 25,000 customers. CellPraxis is a bioengineering company that invests in research projects involving stem cell therapy. Some of these projects are conducted in partnership with institutions like the Federal University of Rio de Janeiro, Federal University of So Paulo, the University of South Florida and Saneron CCEL Therapeutics, Inc. (a USA based biotechnology company dedicated to stem cell research).

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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Cardiac Cell Therapy Phase III Trial to Treat Refractory Angina

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