Oversight and management of a cell therapy clinical trial network: experience and lessons learned

Contemp Clin Trials. 2011 Sep;32(5):614-9. doi: 10.1016/j.cct.2011.05.003. Epub 2011 May 17.


The Cardiovascular Cell Therapy Research Network (CCTRN), sponsored by the National Heart, Lung, and Blood Institute (NHLBI), was established to develop, coordinate, and conduct multiple collaborative protocols testing the effects of cell therapy on cardiovascular diseases. The Network was born into a difficult political and ethical climate created by the recent removal of a dozen drugs from the US formulary and the temporary halting of 27 gene therapy trials due to safety concerns. This article describes the Network's challenges as it initiated three protocols in a polarized cultural atmosphere at a time when oversight bodies were positioning themselves for the tightest vigilance of promising new therapies. Effective strategies involving ongoing education, open communication, and relationship building with the oversight community are discussed.

MeSH terms

  • Cardiovascular Diseases / therapy*
  • Cell- and Tissue-Based Therapy / ethics*
  • Cell- and Tissue-Based Therapy / methods
  • Clinical Trials Data Monitoring Committees
  • Community Networks*
  • Ethics Committees, Research*
  • Ethics, Research*
  • Humans
  • Safety*
  • United States
  • United States Food and Drug Administration