CLBS10

Phase 2 Product Candidate for ST-Elevation Myocardial Infarction (STEMI)

CLBS10 (formerly NBS10) is being developed to treat the damaged heart muscle following an acute myocardial infarction (“AMI” or heart attack).  CLBS10 is thought to work by increasing microvascular blood flow in the heart muscle via new blood vessel development and formation. These new vessels can reverse the restriction of blood supply caused by a heart attack and rescue the damaged tissue from eventual cell death. 

Results from the CLBS10 Phase 2 study (PreSERVE-AMI study) in patients with ST-elevation myocardial infarction (STEMI) and left ventricular dysfunction were presented at the 2014 American Heart Association meeting. Updates were also presented at the American College of Cardiology meeting in March of 2015.


PreSERVE 6- and 12-month Interim Conclusions*

  • CD34 cell dose-dependent trend in reduced major adverse cardiac events (MACE)
  • Reduced serious adverse events (SAEs) frequency trend in higher CD34 cell dose groups (12 month data)
  • No deaths in the CLBS10 treated group (12 month data)
  • CD34 cell dose-dependent trend in improved left ventricular ejection fraction (LVEF) and in reduced infarct size
  • No correlation between experimental endpoint of perfusion and treatment

* Based on data collected at 6 months except where noted

Taken together, these preliminary results suggest that CLBS10 positively impacts the preservation of myocardial function and the prevention of adverse events post-STEMI. The favorable clinical outcomes encourage continued development. For more details, please visit the trial's listing on clinicaltrials.gov.

PreSERVE Phase 2 Study Design

ClinicalTrials.gov: NCT01495364

•   Randomized (1:1), 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 ≥ 10 million ± 20% CD34+ cells

•   Dose determined by volume of cells aspirated and manufacturing

Control

•   Matching infusion with placebo