Cell therapy and satellite centers: The cardiovascular cell therapy research network experience

Abstract

Due to the changing population in patients with myocardial infarction, recruiting patients in clinical trials continues to challenge clinical investigators. The Cardiovascular Cell Therapy Research Network (CCTRN) chose to expand the reach and power of its recruitment effort by incorporating both referral and treatment satellite centers. Eight treatment satellites were successfully identified and they screened patients over a two year period. The result of this effort was an increase in recruitment, with these treatment satellites contributing 30 percent of the patients to two of the three Network studies. The hurdles these satellite treatment centers faced and how they surmounted them provide instruction to clinical research groups eager to expand to satellite systems and to health care practitioners who are interested in taking part in multicenter clinical trials.

Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in Patients With Acute Myocardial Infarction Based on Individual Patient Data

“…Although the ACCRUE database continues to recruit data, it cannot replace large-volume, prospective randomized studies, such as the ongoing BAMI trial (ClinicalTrials.gov Identifier: NCT01569178) or the CCTRN network. 26,27 …”

Clinical Trials in Cardiology

“…4 We disseminate news about our trials by first using mass mailings, then the internet, then social media, and finally we promulgate useful templates for recruitment strategies among ourselves. 5 The Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) trial 2 that successfully recruited patients in Scandinavia based on drawing potential subjects from an underlying and well-developed registry demonstrates the possibility of success when there is a solid patient database available.…”

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

“…CCTRN was able to maneuver a complicated landscape and successfully completed these three trials in a timely fashion. As part of the CCTRN initiative, several manuscripts have been published, or are in press, detailing the experience of the Network in regards to details of cell processing, use of satellite centers for recruitment and oversight/management challenges [17-19]. However, in addition to these logistical and scientific hurdles, several unique challenges not all of which were anticipated, were encountered by the Network, which was able to successfully navigate them in an efficient manner.…”