BioRestorative Therapies
Delivering Breakthrough Treatments with the Prowess of Regenerative Medicines

In recent times, regenerative medicine has shown great potential in enhancing patient outcomes and improving the quality of care—especially for those suffering from chronic lower back pain. For years, the prevalent treatment options included opioid pain relievers, steroid injections, and invasive surgeries that come with increased risks pertaining to opioid addiction or side effects and do not deliver the required clinical outcomes and sustained therapeutic benefits. On the other hand, regenerative medicine utilizes the unique capability of stem cells to regenerate and remodel damaged or diseased tissues. Its implications are game-changing as stem cell therapies promise to regenerate and remodel damaged tissues, providing sustained and long-term clinical benefits.

Leveraging this ground-breaking technology in a novel manner is one of the leading biotech clinical developers, BioRestorative Therapies. The company is pioneering the idea of conditioning one’s own regenerative potential to treat and cure major diseases. “We are going to introduce a paradigm-shifting technology within the spine treatment forte, revolutionizing the entire orthopaedic space. With our proprietary products BRTX-100TM and ThermoStemTM, we aim at improving the quality of care for patients enduring chronic lumber disc disease and metabolic disorders including obesity and diabetes,” states Lance Alstodt, the President, CEO, and Chairman of the Board at BioRestorative Therapies.

BRTX-100TM is anticipated to be a safer, cost-effective, and viable alternative product to treat damaged and degenerated discs compared to the current standard of care. This product is designed and engineered to target the disc area and other avascular zones under low oxygen tension. It is an autologous stem cell product that employs one’s own mesenchymal stem cells to help with the healing process. BRTX-100TM is an individualized or a complimentary surgical solution by utilizing the patients’ stem cells to foster therapeutic benefits.This product leverages a proprietary method of harvesting the stem cells and culturing them in a low oxygen environment called hypoxia, to imitate the same environment of the disc within the body.

With our proprietary products BRTX-100 and ThermoStem, we aim at improving the quality of care for patients enduring back pain due to chronic lumber disc disease and metabolic disorders including obesity and diabetes

The company then adds the patients’ autologous platelet lysates (APL) to these cultured cells, creating BRTX-100TM. APL contains several growth factors that support the stem cells to initiate their tissue repair through angiogenesis, cellular chemotaxis, and remodeling of the extracellular matrix. Once ready, the product is delivered through a single injection into the nucleus of the patient’s disc, which would foster regeneration, healing and act as an anti-inflammatory agent. These properties have been achieved through several years of preclinical research, building out animal models, optimizing the number of cells used for delivery, and improving the overall manufacturing process.

To target metabolic diseases such as obesity and type 2 diabetes, BioRestorative Therapies has developed its ThermoStemTM program, an allogenic cell-based therapy that utilizes brown adipose-derived stem cells to generate new brown fat tissues. The company was the first firm to identify and produce data regarding this novel approach to stem cell population, employing one cell source to treat several patients. Based on the preclinical data and clinical outcomes on the animal models, once a patient is transplanted with the artificial brown adipose tissue construct, it mimics the naturally occurring brown adipose depots that help regulate metabolic homeostasis in humans. Based on animal models, expected positive clinical outcomes include weight loss, decreased circulating glucose levels, and reduced lipid levels. In effect, patients will face lesser risks associated with obesity and diabetes. ThermoStemTM is expected to work effectively on patients suffering from metabolic diseases and associated co-morbidities.

At present, BRTX-100TM is undergoing a phase two clinical trial under the authorization of the FDA, after which the company will be able to validate that this technology meets its clinical endpoints of decreasing pain and improving function. ThermoStemTM is expected to proceed into trials by early 2022. “With our novel approach, we leverage the strength of the body and its therapeutic potential to maximize clinical outcomes. This will help us emerge as a clinical stage biotech company of the future aimed at meeting the unmet needs of patients,” concludes Francisco Silva, the Chief Scientist and VP, R&D at BioRestorative Therapies.