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IND application for clinical trial of treatment of degenerative disc disease.

MELVILLE, N.Y., January 9, 2017 -- Bio-Restorative Therapies, Inc. (BRTX) said it has submitted an Investigational New Drug Application (IND) to the FDA to seek clearance to begin a clinical trial using a proprietary drug to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs.

BRTX-100 is formulated using a patient's own cell population (autologous). It comprises hypoxic cultured mesenchymal stem cells (MSCs) optimized for a non-surgical, conservative intradiscal procedure that can be performed in a physician's office.

The company said current non-surgical options, including physical therapy, steroids, and narcotic pain medication, provide limited relief of symptoms.

Disc/spine surgery is often the only alternative for continued treatment.

"We believe that BRTX-100 has the potential to become the standard of care for the conservative, non-surgical treatment of protruding and bulging lumbar discs," the company said.

The BRTX-100 production process involves collecting a patient's bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells.

In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient's damaged disc.

The treatment is intended for patients whose pain has not been alleviated by noninvasive procedures and who potentially face the prospect of surgery.


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Title Annotation:In The Clinic...
Publication:Stem Cell Research News
Date:Jan 16, 2017
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