Implementation of Cardovascular Cell Therapy Network trials: challenges, innovation and lessons learned from experience in the CCTRN

Abstract

The cardiovascular cell therapy network was developed by the National Heart, Lung and Blood Institute to design and conduct clinical trials to advance the field of cardiovascular (CV) cell-based therapy. The Cardiovascular Cell Therapy Network successfully completed three clinical trials involving approximately 300 subjects across five centers and six satellites. Although the concept of a network within clinical trials research is not new, the knowledge gained in the implementation of such large-scale trials, particularly in novel therapeutic areas such as cell therapy is not often detailed in the literature. The purpose of this communication is to summarize key factors in achieving network goals and share the knowledge gained to promote success in future cardiovascular disease cell therapy trials and networks.

Keywords::

• acute myocardial infarction
• cardiovascular cell therapy network
• cardiovascular disease
• FOCUS
• heart failure
• LateTIME
• network
• stem cell therapy
• TIME

Financial & competing interests disclosure

The authors were partially supported through funding received by the CCTRN provided by the NHLBI under cooperative agreement 5 UM1 HL087318-07. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• • The concept of a network, although not new, had not been previously utilized in the field of cardiovascular cell therapy.

• • Early stem cell trials for cardiovascular (CV) disease therapy indicating benefit in left ventricular (LV) function prompted the development of the Cardiovascular Cell Therapy Network trials.

• • The National Heart, Lung and Blood Institute initiated network was tasked to design and implement multiple trials of CV disease cell therapy for acute myocardial infarction and chronic LV dysfunction.

• • The network was able to successfully complete three studies, TIME, LateTIME and FOCUS, across five centers in a timely fashion.

• • Development of a solid communication structure was an important factor in successful implementation of these trials as it allowed efficient flow of information and timely feedback on time-sensitive issues.

• • Although recruitment was challenged by better than expected recovery of LV function and an FDA hold, all three trials reached their targeted recruitment goals.

• • The network was able to forge new ground in actively working with industry to develop strong relationships within a network setting, which had been previously not been done within the CV cell therapy field.

• • As the field of CV cell therapy rapidly expands into new target populations and alternative cell types, the network experience lends new insight going forward into implementation of trials in this burgeoning field.

Notes