BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ: BRTX), a clinical stage company focused on stem cell-based therapies, today announced that it has initiated the site selection process for its active Phase 2 clinical trial targeting chronic lumbar disc disease.
BioRestorative’s Phase 2 trial is a double-blind controlled, randomized study to evaluate the safety and preliminary efficacy of a single dose intradiscal injection of BRTX-100. A total of up to 99 eligible patients will be randomized at 15 centers in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion.
“As we prepare to initiate enrollment for our Phase 2 clinical trial and first patient dosed, we will carefully vet our clinical sites so that each is capable of meeting our trial goals and timelines.” said Lance Alstodt, the Company’s CEO.
Mr. Alstodt continued, “Site selection is a critical process in clinical trials. PRC Clinical (the Company’s CRO) and BioRestorative are evaluating clinical sites with a proven track record in disc and pain related studies. The track record will include a comprehensive understanding of, and a careful adherence to, good clinical practice (GCP) trial guidelines. A well-trained, experienced clinic staff is also essential, as is a patient population that is capable of meeting study enrollment goals and timelines.”
“PRC Clinical has extensive experience in managing and executing clinical trials, especially as they relate to cell-based therapies to target pain related disorders. We are identifying qualified sites with a proven track record capable of meeting BioRestorative’s enrollment and trial timeline,” said Curtis Head, CEO of PRC Clinical.