Autologous G-CSF mobilized CD34 for angina

Chicago, IL -

The use of stem cells for myocardial repair was originally proposed after mouse studies demonstrated what appeared to be human bone marrow derived stem cells differentiating into myocardium. Subsequently, these experiments were translated into clinical studies, which utilized autologous bone marrow cells as sources of stem cells. Statistically significant increases in some efficacy parameters were seen in a double blind study study as well as another major randomized trial.

Patients eager to attain stem cell therapy without waiting for clinical trials have been treated at ex-US venues with reports of positive results.

In a recent study (Losordo et al. Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Circulation. 2007 Jun 26;115(25):3165-72) 24 patients with angina that were not eligible for revascularization were selected, of which 18 were randomized to receive escalating doses of autologous stem cell therapy and 4 placebo control. The stem cell therapy consisted of G-CSF mobilized Isolex-isolated CD34 cells. The cells were administered using electromechanical mapping of the myocardium using a NOGA system. Of the 18 patients in the treated group, subgroups of 4 patients received 5 × 10(4), 1 × 10(5), and 5 × 10(5) cells per kilogram. Cells were administered in a total volume of 2 ml, divided into 10 intramyocardial, transendocardial injections into areas identified as viable but ischemic. No dose dependent efficacy or adverse effects were observed. Although the study was not powered for efficacy determination, trends towards lower angina frequency, decreased nitroglycerine usage, increased exercise time, and decreased Canadian Cardiovascular Society class were observed in the patients receiving CD34 cells compared to placebo controls. The lead author, Dr Douglas W. Losordo from Feinberg Cardiovascular Research Institute and Program in Cardiovascular Regenerative Medicine, Division of Cardiovascular Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital, Chicago, Ill is planning to expand the study to a multi-center 150 patient trial.