BioRestorative Therapies nabs FDA IND clearance for Phase 2 trial of its autologous cultured mesenchymal stem cell therapy, ‘BRTX-100″ for spine conditions
BioRestorative Therapies, a regenerative medicine company focused on stem cell-based therapies, has announced that the FDA has cleared its Investigational New Drug (“IND”) application for BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, for the treatment of chronic cervical discogenic pain (“cCDP”). The problem? Chronic Cervical […]
BioRestorative Therapies, a regenerative medicine company focused on stem cell-based therapies, has announced that the FDA has cleared its Investigational New Drug (“IND”) application for BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, for the treatment of chronic cervical discogenic pain (“cCDP”).
The problem? Chronic Cervical Discogenic Pain:
Chronic neck pain is a considerable public health burden that accounts for one of the top five chronic pain conditions. The pain can range from cervical intervertebral discs, facet joints to atlantoaxial joints. Cervical discogenic pain syndrome is a common source of neck pain with a reported prevalence between 16% to 41%. Cervical discs have a rich supply of nerve fibers that are prone to structural disruption and inflammatory reaction that makes them susceptible to pain. The commonly affected levels are C5/C6 and C6/C7, with C7 being the most common nerve root involved. Initially, the symptoms present proximally, but they can later progress to brachialgia. 1
“We are taking a comprehensive approach to leveraging our technology throughout the spine to bring effective pain relief and functional improvement to millions of patients. To that end, we are laying plans to evaluate the safety and preliminary efficacy of intradiscally injected BRTX-100 for patients with cCDP in a double-blind, sham-controlled, randomized Phase 2 study as soon as is practicable. In the meantime, we continue to advance our FDA Fast Track-designated BRTX-100 chronic lumbar disc disease (cLDD) program” said Lance Alstodt, Chief Executive Officer of BioRestorative.
The potential solution?
• Disc/Spine Program (brtxDISC ™ ): BioRestorative says its lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. They intend that the product will be used for 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. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.
Other products from BioRestorative Therapies:
• Metabolic Program (ThermoStem ® ): The company is developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. They say that BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Reportedly, initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.
• BioCosmeceuticals: The company also operates a commercial BioCosmeceutical platform. The current commercial product, which they say is formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, the company also intends to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA) approvals in the emerging BioCosmeceuticals space.
1 Saini A, Mukhdomi T. Cervical Discogenic Syndrome. 2023 Apr 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan–. PMID: 32310420.
