brtxDISC™ Program (Disc Implanted Stem Cells)
Treatment for Chronic Lumbar Disc Disease
Our lead cell therapy candidate, brtxDISC™, consists of autologous (a patient’s own) mesenchymal stem cells derived from adult human bone marrow. We are developing a non-surgical, minimally invasive procedure designed for the treatment of Chronic Lumbar Disc Disease (specifically bulging, protruding and herniated discs), which may offer relief from lower back pain, buttock and leg pain, or numbness and tingling in legs or feet.
More than 65 million Americans suffer from lower back pain annually. By the age of 50, 85% of the population will show evidence of disc degeneration. The vast majority of these cases are asymptomatic.
Patients who suffer intractable pain or face neurological compromise, like weakness in their extremities or incontinence, may require surgical intervention.
Open surgeries like laminectomy and discectomy and micro discectomy require general anesthesia and are physically disruptive. In some cases, bone and ligaments may need to be removed for the surgeon to gain access to the herniated disc, leading to long recovery times and post-operative pain.
Our procedure is intended to offer a much-needed alternative to back surgery by addressing the large gap that currently exists in disc treatments between non-invasive and invasive surgical procedures. Not only could this program potentially eliminate surgery in many cases, but it could also provide a substantially more effective treatment than current non-invasive therapies with a design to be curative.
The Company has completed a successful pre-IND meeting with the Food and Drug Administration (FDA) and is preparing to file an IND submission for a clinical trial in the United States.
• As the nucleus pulposus loses turgor and elasticity, the annulus decreases in size and the disc bulges outwards beyond the vertebral margins.
• Herniation of the nucleus pulposus through an annular defect causes protrusion of disc material beyond the margin of adjacent vertebral end plate.
The procedure, utilizing a non-surgical re-transplantation of your stem cells, can be performed in a physician’s office and involves the delivery of your cells to the damaged disc so that they can “repair” the damaged region. BRT expects that there will be hundreds of doctors, who already have experience performing intradiscal injections, who will be able to perform this procedure globally.
The Company is developing a proprietary medical device (patent pending) that allows for precise delivery of stem cells to be used in cell-based therapies, as well as potentially other clinical indications that may benefit from the use of this device.
Below is one sample of the success that the disc treatment can have:
Problem: Chronic back and leg pain due to lumbar disc bulge
Treatment: Stem Cell Disc Procedure
Outcome: Just 3 months after the disc procedure, the patient had elimination of symptoms and MRI shows significant reduction in size of disc bulge
MRI Before Treatment
MRI After Treatment