EXCLUSIVE: BioRestorative Therapies Adds Additional Sites For Lumbar Disc Disease Trial

BioRestorative Therapies Inc BRTX has entered into agreements with Vantage Clinical Trials LLC for its Phase 2 trial targeting chronic lumbar disc disease (cLDD). 

Vantage Clinical Trials LLC is located in Florida and brings three separate clinical sites to BioRestortive’s Phase 2 trial.

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 its autologous investigational stem cell-based therapeutic, BRTX-100. 

Related: EXCLUSIVE: BioRestorative Selects Second Site For Its Lumbar Disc Disease Study.

99 eligible patients will be randomized at up to 15 sites in the U.S. to receive either BRTX-100 or control.

“With the execution of the Vantage agreements, we are bringing on board three additional sites with a well-established history of conducting clinical research,” said Lance Alstodt, Chief Executive Officer of BioRestorative Therapies. 

“Adding high-profile sites is our top priority as we ramp up enrollment for our clinical trial targeting cLDD,” he added.

Price Action: BRTX shares closed at $3.10 on Tuesday.