BioRestorative Therapies has completed enrolment of patients for the safety run-in component of its Phase II clinical trial of BRTX-100 for the treatment of chronic lumbar disc disease (cLDD).
Safety and preliminary efficacy of a single dose of BRTX-100 will be assessed in the controlled, randomised prospective and double-blinded study.
The study will enrol up to 99 patients over 15 sites in the US. They will be randomised to receive either the investigational drug (BRTX-100) or a control in a 2:1 approach.
BioRestorative Therapies CEO Lance Alstodt said: “Positive safety data would enable us to initiate unrestricted enrolment across all of our clinical sites and, of course, establish a strong safety profile for BRTX-100.
“In addition, we would be able to leverage the BRTX-100 platform across other indications within the body on an investigational basis with potentially a shorter timeline from a regulatory pathway perspective.”
A cell therapy, BRTX-100 is formulated from autologous (or a person’s own) cultured mesenchymal stem cells.
Utilising the company’s proprietary technology, the BRT X-100 production process involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells.
It is intended to be used for the non-surgical treatment of lumbosacral disc disorders or as a complementary therapeutic to a surgical process.
Physician will inject BRTX-100 into the patient’s damaged disc in an outpatient setting.
Patients whose pain has not been relieved by using non-invasive procedures and potentially face the prospect of surgery will be treated with BRTX-100.
The company is also developing a cell-based therapy using brown adipose (fat) derived stem cells for treating obesity and metabolic disorders.
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