BioRestorative Therapies has announced that the first patient has been enrolled in the its phase 2 clinical trial evaluating the safety and preliminary efficacy of BRTX-100, an autologous bone marrow-derived mesenchymal stem cell targeting chronic lumbar disc disease.
Lance Alstodt, CEO of BioRestorative Therapies, said: “Announcing first patient enrolment is our most significant clinical milestone to date and an exciting milestone for BioRestorative’s clinical programs overall. The initiation of patient enrolment in our study reinforces our commitment to treating back pain and is an important step in our efforts to provide patients with potentially improved therapeutic options to treat chronic lumbar disc disease.
“In addition, I am very proud of the BRTX team for its timely execution. This truly remarkable accomplishment of first patient enrolled in only six months from our trial initiation keeps us on schedule to meet our strategic targets.”
BioRestorative’s phase 2 trial is a double-blind controlled, randomised study to evaluate the safety and preliminary efficacy of a single dose intradiscal injection of the company’s autologous investigational stem cell-based therapeutic, BRTX-100.
A total of up to 99 eligible patients will be randomised at up to 15 centres in the USA to receive either the investigational drug or control in a 2:1 fashion.
Jason Lipitz, who is the primary investigator in the clinical trial, added: “Even with the rapid advancements in regenerative medicine across many musculoskeletal disorders over the last decade, there still remain many patients who continue to face unmet needs and experience a high burden of pain and disability.
“With BioRestorative’s trial now underway, we look forward to seeing the potential clinical impact of BRTX-100 to treat chronic lumbar disc disease, which could be a paradigm shift in treating back pain.”