ThermoStem®
Obesity, diabetes, hypertension, hyperlipidemia and certain heart related disorders, have long been seen as contributing to a pandemic in the US—40% of Americans are obese; 30% have type 2 diabetes or pre-diabetes, and half of Americans have at least one major risk factor for heart disease.
To target obesity and metabolic disorders, we’ve developed our ThermoStem® program that uses brown adipose-derived (“brown fat”) stem cells to generate new brown fat tissue. BioRestorative Therapies was one of the first companies to identify and publish data about this novel stem cell population. This population of fat is known to burn, rather than store, energy. Elevated levels of brown fat have been demonstrated to increase metabolism and facilitate weight loss.
Initial preclinical research indicates that increased amounts of activated brown fat in the body may be responsible for additional caloric burning, as well as reduced glucose and lipid levels. Further, researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.
CLINICAL TRIALS
A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
Description:
This is a double-blind, saline-controlled, and randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled. Chronic lumbar disc disease is defined as back and/or radicular pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic measures such as computed tomography (CT), magnetic resonance imaging (MRI), plain film, myelography, discography, or other acceptable means.
Subjects randomized to active treatment will undergo bone marrow harvest for processing into BRTX-100 for intradiscal injection. Subjects randomized to control will also undergo a bone marrow and blood harvest but only receive saline intradiscal injection procedures. Subjects will return to the study site for a visit at Week 2, Week 12, Week 26, Week 52 and Week 104/Early Termination.
The trial will have a Safety Run-In component that will insert a 3+3 design for the initial subjects dosed with BRTX-100 at 40 × 106 cells. Specifically, the randomization scheme will be briefly shifted from the overall trial 2:1 randomization to an initial 3:1 allotment of intradiscal BRTX-100 versus saline control. As such, four subjects will initially be randomized and administered their agents. There will be a 14 day safety follow-up period that must elapse between dosing of each of the first four (4) subjects. Dosing of each subsequent subject in the Safety Run-In component cannot occur until the independent Medical Monitor (MM) reviews the previously-dosed subject’s blinded data, including but not limited to physical examination findings, laboratory values and reported adverse events (AEs) and serious adverse events (SAEs), at the completion of the 14-day visit and documents the findings. If no potential dose- limiting toxicity (DLT) is noted by the MM, the MM will approve the dosing of the next subject. If a potential DLT is noted by the MM, the MM will request that an ad hoc Data Safety Monitoring Board (DSMB) review of unblinded data occur per DSMB Charter before the next subject is dosed.
