Wednesday, 7 August 2013

BioRestorative receives approval to conduct retrospective safety study

BioRestorative Therapies a life sciences company focused on developing stem cell based cellular therapies for various personal medical application announced today that it has received approval from the Western Institutional Review Board to complete a retrospective safety study on selected subjects previously treated by the Company’s brtxDISC™ bulging and herniated disc procedure.

The study is titled “Re-consenting and Follow-Up of Adults from a Retrospective Study Using Autologous Transplantation of Marrow Derived Mesenchymal Stem Cells to Degenerated Intervertebral Disc.



Study objectives are to determine the safety of subjects who received transplants of their own stem cells into their disc, using MRI and Quality of Life Questionnaires. The Board requires that all subjects must be able to consent for themselves to be enrolled in the study, which has been approved to take place at the Centeno-Schultz Clinic in Broomfield, Colorado.

The approval allows BRT to retrospectively collect and analyze clinical data on selected subjects who previously have been treated for bulging or herniated disc disease with the Company’s novel brtxDISC™ procedure. These procedures were performed using BRT’s proprietary therapeutic delivery device cannula system and its proprietary culture method isolating a selective population of mesenchymal stem cells. BRT expects to complete the study within a six-month period.

“This is a significant milestone in taking our brtxDISC™ procedure closer towards an FDA meeting to seek approval for the commencement of our clinical trial. We look forward to collecting this data with the ambition of meeting the safety requirements necessary for us to receive approval and start our trial. Our goal is to compile and present the necessary data to the FDA with the goal of initiating a Phase I or Phase II clinical trial in the early part of next year.” commented Mark Weinreb, Chief Executive Officer of BioRestorative Therapies. 

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