Monday, November 14, 2011

Stem Cell Research Starting to Pay Off

A total of 23 patients took part in the ''Scipio'' trial, all of whom had suffered heart failure due to a previous heart attack. Sixteen were assigned to the stem cell therapy while the other seven received standard care.

...The ground-breaking new treatment involved extracting cardiac stem cells (CSCs) - self-renewing cells that rebuild hearts and arteries - from patients during bypass surgery.
The cells were purified and grown in the laboratory before being injected back into damaged regions of the patients' hearts four months later.

A million CSCs were infused into each patient via a balloon catheter, an expandable device used to open up arteries.

Heart pumping efficiency is assessed by measuring the fraction of blood expelled or ''ejected'' from the left ventricle with each beat.

At the start of the study, the patients had an average left ventricular ejection fraction (LVEF) of 40% or lower. Normal LVEF is 50% or higher.

Over a period of four months patients who underwent the treatment saw an 8.5% improvement in LVEF. After one year, this increased to 12.3%. LVEF did not change in the seven ''control'' patients who did not receive the therapy.

The findings were published today in an online edition of The Lancet medical journal. They were also presented at the American Heart Association's Scientific Sessions meeting in Orlando, Florida.

Magnetic Resonance Imaging (MRI) scans conducted on a number of patients showed that scarring in their hearts had been reduced.

The small Phase I study was primarily designed to assess safety rather than effectiveness. _Telegraph
As noted, the study was a "Phase I" clinical study meant to determine the safety of the treatment. In later, Phase II studies, efficacy will be looked at more closely. The results from this trial are quite encouraging -- modest but significant -- allowing a greater range of activity for the treatment group, post trial.

More from Genetic Engineering News:
Stage A of the ongoing open-label Phase I SCIPIO (Stem Cell Infusion in Patients with Ischemic cardiOmyopathy) study, by investigators at the University of Louisville and Brigham and Women’s Hospital, is evaluating CSC transplantation in patients with severe heart failure secondary to ischemic cardiomyopathy. The target population includes patients who underwent coronary artery bypass grafting (CABG), had LV ejection fraction (EF) of less than or equal to 40%, and a previous myocardial infarction.

Treated patients were administered with about a million autologous CSCs by intracoronary infusion, at a mean of 113 days after CABG. To generate the cardiac stem cells, tissue from the right atrial appendage was harvested from the patients at the time of CABG, and CSCs were isolated and expanded at the Brigham and Women’s Hospital.

...The trial has been led by Roberto Bolli, M.D., at the University of Louisville and Piero Anversa, Ph.D., at Brigham and Women's Hospital/Harvard Medical School in Boston. "The results are striking," Dr. Bolli states. "While we do not yet know why the improvement occurs, we have no doubt now that ejection fraction increased and scarring decreased. If these results hold up in future studies, I believe this could be the biggest revolution in cardiovascular medicine in my lifetime."

The published paper in The Lancet is titled "Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised Phase I trial.” _GenEngNews
Heart muscle is relatively uncomplicated, as far as vital organs go, so it is not a great surprise that such a simple stem cell replacement therapy might work. Liver and pancreas may be similarly amenable to simple stem cell infusion. But other organs will require more clever designs for creating replacement tissue from stem cells and scaffolding.

In terms of numbers of persons potentially affected by this therapy for heart failure, the number will easily go into the millions in North America alone. Optimal therapy may require multiple infusions over time, to allow the heart to assimilate the new cells. More will be known as the research progresses into further stages.

This is just the beginning.



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