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BRTX-100 is intended for the treatment of chronic lumber disc disease. Credit: Sasun Bughdaryan on Unsplash.

Northwell Health and Northwell’s Feinstein Institutes for Medical Research have entered into a clinical trial agreement to participate in BioRestorative Therapies’ Phase II clinical trial of BRTX-100 for the treatment of chronic lumber disc disease (cLDD).

A new cell-based therapeutic, BRTX-100 is designed to target areas of the body having little blood flow.

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An office-based injection procedural approach of BRTX-100 introduces patient’s own cultured mesenchymal stem cells to target the harsh environment of the intervertebral disc.

Designed to assess the preliminary efficacy and safety of a single dose of BRTX-100, the double-blinded, randomised, controlled, and prospective study will enrol a total of around 99 patients.

Subjects selected at up to 15 US clinical sites will be randomised into 2:1 ratio to receive either BRTX-100 or control.

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BioRestorative CEO Lance Alstodt said: “We are delighted to enter into such an agreement with Northwell and their world class team of non-surgical and surgical spine clinicians and researchers across the disciplines.

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“We hope to identify other areas where our two organisations can work closely with one another. Research is a very obvious area of focus for both of us and we look forward to exploring strategic possibilities to enhance and strengthen our relationship with Northwell.”

BioRestorative’s cell-based therapy candidate ThermoStem uses brown adipose derived stem cells to target obesity and metabolic disorders.

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