BioRestorative Therapies of Melville, N.Y., received FDA clearance to begin phase two of their BRTX-100 clinical trial.
Here are seven things to know:
1. BioRestorative believes that BRTX-100 can treat chronic lower back pain caused by degenerative disc disease related to bulging discs.
2. BRTX-100, which is formulated using a patient's own cell population in a non-surgical procedure, is injected into the patient's damaged disc.
3. The treatment's goal is to reduce pain and increase patients' function.
4. Phase two of the trial includes 72 patients whose response to one dose of BRTX-100 will be evaluated in order to determine its safety and efficacy.
5. The dose will be administered via intradiscal injection into a disc that has been impacted by chronic lumbar disease and hasn't responded to conservative treatments such as oral injections and physical therapy.
6. BRT submitted an investigational new drug application to the FDA in January in order to obtain the clearance needed to commence the clinical BRTX-100 trial.
7. The company develops therapeutic products using cell and tissue protocols such as adult stem cells.
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