Combined delivery of bone marrow-derived mononuclear cells in chronic ischemic heart disease: rationale and study design

Clin Cardiol. 2013 Aug;36(8):435-41. doi: 10.1002/clc.22148. Epub 2013 May 29.


Background: Treatment with bone marrow-derived mononuclear cells (BM-MNC) may improve left ventricular (LV) function in patients with chronic ischemic heart disease (IHD). Delivery method of the cell product may be crucial for efficacy.

Hypothesis: We aimed to demonstrate that the combination of intramyocardial and intracoronary injection of BM-MNC is safe and improves LV function in patients with chronic IHD.

Methods: After a safety/feasibility phase of 10 patients, 54 patients will be randomly assigned in a 1:1:1 pattern to 1 control and 2 BM-MNC treatment groups. The control group will be treated with state-of-the-art medical management. The treatment groups will receive either exclusively intramyocardial injection or a combination of intramyocardial and intracoronary injection of autologous BM-MNC. Left ventricular function as well as scar size, transmural extension, and regional wall-motion score will be assessed by cardiac magnetic resonance imaging studies at baseline and after 6 months. The primary endpoint is the change in global LV ejection fraction by cardiac magnetic resonance from 6 months to baseline.

Results: The results, it is hoped, will have important clinical impact and provide essential information to improve the design of future regenerative-medicine protocols in cardiology.

Conclusions: As cell delivery may play an important role in chronic IHD, we aim to demonstrate feasibility and efficacy of a combined cell-delivery approach in patients with decreased LV function.

Trial registration: NCT01666132.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bone Marrow Transplantation / methods*
  • Chronic Disease
  • Clinical Protocols
  • Feasibility Studies
  • Humans
  • Injections
  • Leukocytes, Mononuclear / transplantation*
  • Magnetic Resonance Imaging
  • Myocardial Contraction
  • Myocardial Ischemia / diagnosis
  • Myocardial Ischemia / physiopathology
  • Myocardial Ischemia / surgery*
  • Myocardium / pathology
  • Recovery of Function
  • Research Design*
  • Stroke Volume
  • Switzerland
  • Time Factors
  • Treatment Outcome
  • Ventricular Function, Left

Associated data