Other groups are putting their focus on degenerative disc disease, a common condition that can lead to near-constant and debilitating pain (5), and specifically on using cell therapy to rebuild the intervertebral disc material (nucleus pulposus) that serves as a shock absorber between the individual vertebra.
One of the companies with significant research in this area is BioRestorative Therapies of Melville, New York, which is growing and expanding stem cells from the patient’s bone marrow, but doing so under hypoxic conditions that mimic those in the normal intervertebral space (6). “So basically we are enriching the cells to be able to survive in this harsh environment,” said Francisco Silva, the company’s chief scientist and vice president of research and development (Figure 3). The researchers combine the cells with platelet lysate, a blood component that is rich in growth factors and nutrients for the cells, and cryopreserve the final cell product, which they call BRTX-100.
“Once the U.S. Food and Drug Administration (FDA) authorizes the sale of BRTX-100, we would ship it to your doctor, and with a 30-minute procedure the material would be injected into your disc in a 1.5 ml solution, and that’s it,” he described. The stem cells function in a couple of different ways. “Stem cells by nature are anti-inflammatory (and) release factors to block the inflammation process,” he explained. The company’s initial animal study showed increased disc height following treatment (Figure 4). Another animal study is planned to examine BRTX-100’s mechanism of action, and to measure changes in pain level following treatment.
The FDA authorized BioRestorative Therapies to initiate a phase 2 clinical trial of the BRTX-100 cell product, which will provide for the study of 99 patients.
Figure 3. Francisco Silva, chief scientist and vice president of research and development for BioRestorative Therapies of Melville, New York, which is developing a cell-therapy product called BRTX-100 to rebuild intervertebral disc material
Figure 4. Silva examines a rabbit disc treated with BRTX-100 (inset). The company’s initial animal study demonstrated increased disc height following treatment. Images courtesy of BioRestorative Therapies.
Besides the BRTX-100 cell product, the company is also pursuing an additional cell-therapy project: utilizing brown adipose (fat) derived stem cells for therapeutic purposes. Since brown adipose tissue expends energy (as opposed to white adipose tissue, which stores it), the company’s goal is to develop an implantable brown adipose tissue construct, which it hopes to use for the treatment of metabolic diseases and disorders, such as type 2 diabetes, obesity and hypertension. The company is working in collaboration with the University of Pennsylvania to research brown adipose biology and its role in metabolic disorders and has also retained the University of Utah to provide research services for this program.
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