First Patient Enrolled in BioRestorative Therapies’ Chronic Lumbar Disc Disease Trial

BioRestorative Therapies Inc. has enrolled the first patient in its Phase 2 clinical trial evaluating the safety and preliminary efficacy of BRTX-100, an autologous bone marrow-derived mesenchymal stem cell targeting chronic lumbar disc disease (cLDD). The clinical study is being conducted at up to 15 U.S. sites.
 
“Announcing first patient enrollment is our most significant clinical milestone to date and an exciting milestone for BioRestorative’s clinical programs overall,” CEO Lance Alstodt said. “The initiation of patient enrollment in our study reinforces our commitment to treating back pain and is an important step in our efforts to provide patients with potentially improved therapeutic options to treat chronic lumbar disc disease. This first patient enrolled in only six months from our trial initiation keeps us on schedule to meet our strategic targets.”
 
BioRestorative’s Phase 2 trial is a double-blind controlled, randomized study to 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 up to 99 eligible patients will be randomized at up to 15 centers in the United States to receive either the investigational drug (BRTX-100) or control in a two to one fashion.
 
“Even with the rapid advancements in regenerative medicine across many musculoskeletal disorders over the last decade, there still remain many patients who continue to face unmet needs and experience a high burden of pain and disability,” said Jason Lipitz, M.D., primary investigator in the clinical trial. “With BioRestorative’s trial now underway, we look forward to seeing the potential clinical impact of BRTX-100 to treat chronic lumbar disc disease, which could be a paradigm shift in treating back pain.”
 
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. The Disc/Spine Program’s 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. The product is designed for use 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.  

BioRestorative Therapies also is developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. 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.