Clinical Trials

The PreSERVE Study: On-Going Phase 2 Clinical Trial

Summary of PreSERVE Study
Design Randomized (1:1), Phase 2, double blind, placebo controlled trial for post-AMI (STEMI) patients
Primary endpoints and Key secondary endpoint Change in cardiac perfusion from baseline to 6 months (exploratory) Incidence rates of SAEs and MACE (regulatory – AMI)LVEF change from baseline to 6 months (regulatory – heart failure)
Key Inclusion Criteria Confirmation of ST Elevation MI; ejection fraction < 48% at day 4 by CMR; state of the art care post stenting
Study Size 161 patients, 60 centers in United States
Treatment Single dose via infarct related artery with minimum dose for release ≥10M (million) ±20% CD34+ cells
Control Matching infusion with placebo

PreSERVE 6-month interim analysis conclusions:

  • No correlation between experimental endpoint of perfusion and treatment
  • CD34 cell dose-dependent reduction in SAEs incidence
  • CD34 cell dose-dependent reduction in MACE incidence
    • Associated with reduced 1-year mortality rate
  • Clinical and regulatory “hard” endpoints provide compelling results for continued development
  • Results provide key insights regarding important design parameters of next clinical development step

While all 6 month data has been collected, it is subject to ongoing analysis, and results reported at this time, although promising, are preliminary. There can be no assurance that further analysis may not reveal negative, or less promising, results.

NBS10 –  Phase 1 Clinical Trial Summary

The Company reported results of a Phase 1 study of NBS10 treating 31 patients with damaged heart muscle following AMI In December 2010. The completed Phase 1 study of NBS10 showed a statistically significant dose-related improvement in myocardial perfusion (the flow of blood to the heart muscle). 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 size (dead tissue caused by shutting off the blood supply).

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NeoStem - Cell Therapy Development - Clinical