Michael Barbella, Managing Editor02.05.24
BioRestorative Therapies Inc. has released preliminary 26–52 week blinded data from the ongoing Phase 2 clinical trial of BRTX-100 in subjects with chronic lumbar disc disease (cLDD). The company presented the results over the weekend at the Orthopaedic Research Society (ORS) 2024 Annual Meeting (Feb. 2-6) in Long Beach, Calif.
BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative Therapies' lead clinical candidate. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study, where up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo.
BRTX-100 is formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from bone marrow. The product will be used in the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. 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 treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. The Phase 2 clinical trial will evaluate the product's efficacy in treating chronic lower back pain arising from degenerative disc disease.
“We are excited by this opportunity to share, for the very first time, preliminary data from the ongoing Phase 2 clinical trial of BRTX-100 in the treatment of cLDD,” BioRestorative Therapies CEO Lance Alstodt said. “As interest in the potential clinical benefits of BRTX-100 grows, it is important that we continue to drive awareness of this novel therapeutic candidate amongst researchers, regulators and clinicians through clinical presentations at important meetings like ORS.”
Melville, N.Y.-based BioRestorative Therapies develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Its two core programs relate to the treatment of disc/spine disease and metabolic disorders.
BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative Therapies' lead clinical candidate. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study, where up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo.
BRTX-100 is formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from bone marrow. The product will be used in the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. 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 treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. The Phase 2 clinical trial will evaluate the product's efficacy in treating chronic lower back pain arising from degenerative disc disease.
“We are excited by this opportunity to share, for the very first time, preliminary data from the ongoing Phase 2 clinical trial of BRTX-100 in the treatment of cLDD,” BioRestorative Therapies CEO Lance Alstodt said. “As interest in the potential clinical benefits of BRTX-100 grows, it is important that we continue to drive awareness of this novel therapeutic candidate amongst researchers, regulators and clinicians through clinical presentations at important meetings like ORS.”
Melville, N.Y.-based BioRestorative Therapies develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Its two core programs relate to the treatment of disc/spine disease and metabolic disorders.