Regenerative Medicine Center

Current Clinical Trials

Current clinical trials:

Efficacy and safety of targeted intramyocardial delivery of Auto CD34+ cells for the improvement in exercise capacity in subjects with refractory angina

Clinical Trials

Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. The primary objective of this study is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment.

Patients on this study will be randomized to one of three treatment arms:

  1. Treatment with their own autologous CD34+ stem cells
  2. Treatment with placebo (control)
  3. Standard of care treatment.

Patients on the first and second treatment arms will undergo stem cell mobilization and apheresis (collecting the cells from the body). They will then receive CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue.

For specific clinical trial information, go to clinicaltrials.gov study ID NCT01508910.

A prospective randomized double blind placebo controlled phase II trial of intra-coronary infusion of AMR-001, a bone marrow derived autologous CD34+ selected cell product, in patients with acute myocardial infarction

The study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of infarct-related artery infusion of AMR-001, an autologous bone marrow derived cell therapy enriched for CD34+ cells. AMR-001 is administered five to 11 days post-stent placement in patients diagnosed with an ST segment elevation myocardial infarction. Approximately 160 subjects, age 18 and older, will be randomized 1:1 between the treatment group and control group.

For specific clinical trial information, go to clinicaltrials.gov study ID NCT01508910.