Currently Active Clinical Trials
In January 2012, we enrolled the first patient in our PreSERVE Phase 2 trial, a multicenter, randomized, double-blind, placebo-controlled U.S. clinical trial to evaluate the efficacy and safety of a single intra-coronary infusion of at least 10 million cells of AMR-001, post STEMI, in subjects with ejection fractions of 48% or less as measured by cardiac magnetic resonance imaging (“CMR”). We expect to complete enrollment for this study in 2013 with the first data readout available six to eight months thereafter.
You can learn more about the inclusion criteria and participating centers for the clinical trial at clinicaltrials.gov. Please note that subjects must be treated within a narrow window of time following the heart attack.
Upcoming Clinical Trials
Please join our mailing list to learn more about NeoStem’s upcoming clinical trials as information becomes available, such as a planned Phase 1 clinical trial to evaluate AMR-001 for congestive heart failure and a planned Phase 3 clinical trial to evaluate AMR-001 for AMI.
Past Clinical Trials
The completed Phase 1 study of AMR-001 in 31 patients with damaged heart muscle following AMI showed a statistically significant dose-related improvement in myocardial perfusion. Patients who received 10 million cells (n=5) or 15 million cells (n=4) showed statistically significant improvement in resting perfusion rates at six months as compared to patients who received 5 million cells (n=6) or the control groups (n=15), as measured by Single-photon emission computerized tomography (SPECT). The study data also showed a dose-related trend towards improvement in ejection fraction (the percentage of blood pumped out of the ventricles with each heart beat), end systolic volume (the blood volume remaining in a ventricle at the end of contraction and the beginning of filling, which can be used clinically as a measurement of the adequacy of cardiac emptying), and reduction in infarct (death of tissue caused by shutting off the blood supply) size.