Renew (Aastrom-Ix-Cell)

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TRANSENDOCARDIAL INJECTION OF IXMYELOCEL-T IN SUBJECTS WITH HEART FAILURE DUE TO ISCHEMIC DILATED CARDIOMYOPATHY (IDCM).

Renew (Aastrom-Ix-Cell) [NCT01670981]

Description: This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.

 

Biological: ixmyelocel-T; Other: Vehicle Control

Primary Investigator: Chung

Drug/Device Information
To evaluate transendocardial myeloid cell & lymphoid cell injections in ischemic dilated cardiomyopathy
Randomized 1:1 to autologous Ixmyelocel-T (mixed) stem cells vs. placebo
Aastrom Biosciences
Major Inclusion and Exclusion
Age 30-86, LVEF ≤ 35% and CHF hospitalization within the last 6 months or BNP > 400 or 6MWT < 400m
Ischemic dilated cardiomyopathy (defined as a history of myocardial infarction or ≥ 70% narrowing of a major epicardial artery)
MUST have ICD and be CHF Class III or IV
No BMI ≥ 40, GFR <15, Hemaglobin < 9.0 or Platelets < 50,000