BioRestorative Therapies Inc BRTX has selected the Center for Clinical Research in North Carolina as the company's second contract for its Phase 2 trial targeting chronic lumbar disc disease (cLDD).
BioRestorative develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells.
What Happened: The Phase 2 trial will evaluate the safety and preliminary efficacy of a single dose intradiscal injection of the company's autologous investigational stem cell-based therapeutic, BRTX-100.
A total of 99 eligible patients will be randomized at up to 15 sites in the U.S. to receive either the investigational drug or control in a 2:1 fashion.
The BRTX-100 production process utilizes proprietary technology and 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 company announced site initiation for its cLDD trial last week. The Denver Spine and Pain Institute is the first clinical site initiated.
Price Action: BRTX shares closed 2.45% higher at $3.69 on Tuesday.
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