BioRestorative Therapies announced blinded data from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease, with 50% or more of treated patients reporting improvements >50% across key pain and functional outcome measures and no adverse events related to dose-limiting toxicities.
Of note, the Phase 2 study efficacy endpoint is a greater than 30% improvement in both the Visual Analog Scale and Oswestry Disability Index at 52 weeks, which is the minimum improvement needed to meet clinical efficacy success.
“These blinded data further support the therapeutic potential of our hypoxic-cultured mesenchymal stem cell technology, with patients demonstrating meaningful improvements across key pain and functional outcome measures,” said Lance Alstodt, BioRestorative Therapies President, Chief Executive Officer, and Chairman. “Even with blinded data, this signal provides us with confidence in the ultimate outcome of the study, and optimism moving forward with regard to the ultimate potential for meeting a medical need that has, to date, been inadequately addressed. Importantly, the results also continue to reinforce the favorable safety and tolerability profile observed to date.”
BioRestorative Therapies announced blinded data from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease, with 50% or more of treated patients reporting improvements >50% across key pain and functional outcome measures and no adverse events related to dose-limiting...
BioRestorative Therapies announced blinded data from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease, with 50% or more of treated patients reporting improvements >50% across key pain and functional outcome measures and no adverse events related to dose-limiting toxicities.
Of note, the Phase 2 study efficacy endpoint is a greater than 30% improvement in both the Visual Analog Scale and Oswestry Disability Index at 52 weeks, which is the minimum improvement needed to meet clinical efficacy success.
“These blinded data further support the therapeutic potential of our hypoxic-cultured mesenchymal stem cell technology, with patients demonstrating meaningful improvements across key pain and functional outcome measures,” said Lance Alstodt, BioRestorative Therapies President, Chief Executive Officer, and Chairman. “Even with blinded data, this signal provides us with confidence in the ultimate outcome of the study, and optimism moving forward with regard to the ultimate potential for meeting a medical need that has, to date, been inadequately addressed. Importantly, the results also continue to reinforce the favorable safety and tolerability profile observed to date.”
Copy to clipboard 
