View Full Version : Heart damage improves, reverses after stem cell injections in a preliminary human tri

03-17-2011, 04:15 PM

Heart damage improves, reverses after stem cell injections in a preliminary human trial

March 17, 2011
Researchers have shown for the first time that stem cells injected into enlarged hearts reduced heart size, reduced scar tissue and improved function to injured heart areas, according to a small trial published in Circulation Research: Journal of the American Heart Association.

Researchers said that while this research is in the early stages, the findings are promising for the more than five million Americans who have enlarged hearts due to damage sustained from heart attacks. These patients can suffer premature death, have major disability and experience frequent hospitalizations. Options for treatment are limited to lifelong medications and major medical interventions, such as heart transplantation, according to Joshua M. Hare, M.D., the study's senior author and professor of medicine and director of the Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, University of Miami in Miami, Fla.

Using catheters, researchers injected stem cells derived from the patient's own bone marrow into the hearts of eight men (average age 57) with chronically enlarged, low-functioning hearts.

"The injections first improved function in the damaged area of the heart and then led to a reduction in the size of the heart. This was associated with a reduction in scar size. The effects lasted for a year after the injections, which was the full duration of the study," Hare said.

Specifically, researchers found:

•Heart size decreased an average of 15 percent to 20 percent, which is about three times what is possible with current medical therapies.

•Scar tissue decreased by an average of 18.3 percent.

•And there was dramatic improvement in the function, or contraction, of specific heart areas that were damaged.
."This therapy improved even old cardiac injuries," Hare said. "Some of the patients had damage to their hearts from heart attacks as long as 11 years before treatment."

The researchers had used two different types of bone marrow stem cells in their study — mononuclear or mesenchymal stem cells. The study lacked the power to determine if one type of cell works better than the other. All patients in the study benefited from the therapy and tolerated the injections with no serious adverse events.

Hare's study assessed the effect of stem cell injections differently from other studies of post-heart attack stem cell treatment. His team measured contractility, scar size and structural changes of the heart.

"Studies of bone marrow cell therapy for ischemic heart disease in animals have shown improved ejection fraction (the amount of blood the heart can pump). However, this measurement has not reliably translated to early phase studies in humans," Hare said. "Ejection fraction may not be the best way to measure the success of stem cell therapy in the human heart."

Hare also said their findings suggest that patients' quality of life could improve as the result of this therapy because the heart is a more normal size and is better functioning. "But, we have yet to prove this clinical benefit – this is an experimental therapy in phase one studies. These findings support further clinical trials and give us hope that we can help people with enlarged hearts."

Provided by American Heart Association (news : web)

04-08-2011, 02:39 PM
C3BS Presents Stem Cell Trial DataDrug Discovery & Development - April 06, 2011


The Belgian biotechnology company, Cardio3 BioSciences, a leader in discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, presented detailed data from the Phase 2 clinical trial of C3BS-CQR-1 (C-Cure), its novel stem cell therapy for ischemic cardiomyopathy, at the 60th annual American College of Cardiology in New Orleans, USA.

The data were presented by Dr. Jozef Bartunek, Associate Director of the Cardiovascular Center in Aalst, Belgium and Co-Principal Investigator of the C3BS-CQR-1 (C-Cure) trial. The trial demonstrates that heart failure patients improved heart function and exercise capacity at 6 months following treatment of C-Cure, an innovative and proprietary stem cell therapy based on the company’s “Cardiopoiesis” technology.

The Cardiopoiesis platform is based on fundamental research conducted at Mayo Clinic and is designed to drive the differentiation of adult bone marrow-derived stem cells into cardiac progenitor cells which have the potential to promote heart regeneration when re-injected into the heart of patients suffering from ischemic heart failure.

Study summary
• 45 patients with heart failure secondary to ischemic heart disease were recruited in Belgium and Serbia, and randomized to optimal medical care or optimal medical care plus C-Cure treatment. Demographic and clinical baseline data were similar between 24 controls and 21 patients treated with C-Cure.
• The study showed that delivery of C-Cure is feasible without peri-procedural complications. No evidence of cell-induced systemic toxicity or pro-arrhythmogenicity was observed.
• Cardiac structural and functional parameters, assessed by echocardiography at six months versus baseline showed the benefit of C-Cure treatment.
• On average, left ventricular ejection fraction (LVEF) was significantly augmented over baseline in the C-Cure versus control cohort (5.2±0.6% versus 1±0.7%, p<0.01), translating into a 18.1±2.3% relative increase in systolic function afforded by cell therapy.
• Reduction of end-systolic volume was 3-times larger in the C-Cure group compared to the control group (from 171±9 to 150±9mL, and from 167±8 to 159±8mL, p=0.01, respectively).
• In contrast to the control cohort, which displayed inter-individual variance, C-Cure treatment invariably led to a pattern of improved left ventricular function in all individuals at 6 months follow-up.
• The beneficial effects on cardiac structure and function in the C-Cure group translated into meaningful improved fitness. The 6-min walk test, an index of overall performance, increased from 396±26 at baseline to 449±35 m at six months in C-Cure (+52±19 m) patients while it decreased from 412±19 to 391±25 m (-21±14 m) in the control group between the same time points (p<0.01). To summarize, at 6 months post-therapy, C-Cure treated heart failure patients walked 73 meters more than patients that received optimal standard of care.

Dr. Jozef Bartunek explained: “Data presented today strongly suggest that C-Cure is a promising treatment for heart failure, one of the world’s greatest unmet medical needs. A person living to the age of 40 has a one-in-five risk of developing heart failure and, once the disorder is apparent, a one-in-three chances of dying within a year of diagnosis. With the C-Cure trial, we show improved left ventricular and clinical performance consistent with a generalized therapeutic benefit. Moreover, we proved feasibility and safety of the C-Cure treatment regimen. The overall signs of efficacy in C-Cure treated patients are indeed encouraging and open a new chapter in cardiovascular regenerative medicine.”

Dr. Christian Homsy, CEO of Cardio3 BioSciences, said: “Heart failure affects 117 million people and cannot be cured today as current therapies only reduce the severity of disease symptoms. Regenerative therapies, such as C-Cure, may offer new hope to patients who currently have limited choices and potentially avoid the need for heart transplantation. The positive outcome of this study reiterates our belief that C-Cure can make a real difference to patients suffering from heart failure. Indeed, we are currently planning the next stages of C-Cure development and are committed to taking the steps needed to successfully bring this new and important treatment to patients. With C-Cure, we aim to become the first company with an approved regenerative product for ischemic heart failure.”

Date: April 5, 2011
Source: Cardio3 BioSciences