New published data is consistent with Amorcyte's trial results …
For years it was thought that most damage from a major heart attack was permanent. Dead tissue turns to scar tissue, leading to the heart muscle's gradual deterioration. But now, there is growing optimism that stem cell therapy may help patients with damaged hearts return to a fully functional life, based on results from early studies.
Of course, larger studies have to confirm the results and the devil is in the details. Those details were on display, Tuesday at the … American Heart Association (AHA) conference in Los Angeles.
New published data is consistent with Amorcyte's P1 trial results and supports the ongoing NeoStem sponsored national PreSERVE AMI P2 trial of intra-coronary infusion of AMR-001 (versus placebo) in patients after sustaining a large acute myocardial infarction intended to preserve heart muscle function and prevent adverse clinical events.
Published online on November 6th, 2012 in JAMA, results from the TIME randomized trial showed no effect on heart muscle function of intra-coronary infusion of autologous bone marrow derived mononuclear cells in patients suffering a large AMI regardless if the cells were administered at 3 or 7 days post AMI.
These findings were similar to a prior trial (Late Time) where no effect on heart muscle function was observed in patients who received cells on average 17 days after a large AMI. In these two Time trials the dose of the active cell type in bone marrow MNC, the CD34+ cell, was under 5 million CD34+ cells. Similarly in the Amorcyte P1 trial no effect was observed among patients receiving no cells or as in the Time trials a low dose of CD34+ cells (5 million). in striking contrast, patients in the Amorcyte phase 1 trial who received 10 or more million CD34+ cells did have an observed effect with a significant improvement in perfusion and a tend towards better heart muscle function.
The Bottom Line: Cell therapy may eventually become a therapeutic option for patients following acute myocardial infarction [AMI; heart attack], potentially preventing the transition to end-stage heart failure where cardiac transplantation is currently the only curative procedure available. In an ongoing NBS Amorcyte national "PreServe" AMI trial patients randomized to receive cells will receive no less than 10 million CD34+ cells, a minimum (threshold) dose that … now appears to have been confirmed to be required to observe an effect on heart muscle function. NBS had closed down -$0.01 or -1.52% to $0.65 - still a "BUY" as these findings set yet, another set of dominoes to fall in NBS' favor!
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.