Life sciences company BioRestorative Therapies has secured clearance from the US Food and Drug Administration (FDA) to commence the Phase II clinical trial of BRTX-100 for the treatment of chronic lower back pain in degenerative disc disease caused due to protruding / bulging discs.
BRTX-100 is a cell therapy candidate developed from autologous (a patient’s own cell population) cultured mesenchymal stem cells from the patient's bone marrow, to non-surgically treat protruding and bulging lumbar discs.
The randomised, double-blind, controlled, multi-centre Phase II clinical trial will evaluate the safety and efficacy of a single dose of BRTX-100 in 72 patients.
BioRestorative Therapies president and chief executive officer Mark Weinreb said: “This treatment has the potential to positively impact millions of Americans suffering from chronic lumbar disc disease as an alternative to surgery.
"We believe that this technology can be truly transformative and addresses a large market underserved by current therapies."
The patients will be given an intradiscal injection of the drug into one disc of a chronic lumbar disc disease patient, whose pain is not responsive to other treatment methods such as oral medication, epidural injections and physical therapy.
The trial is intended to decrease the pain due to damaged disc, as well as enhance the function in patients.
BRTX-100 is formulated by collecting a patient’s bone marrow, isolating and culturing hypoxic (low oxygen) mesenchymal stem cells from the bone marrow and cryopreserving them.
The firm has recently obtained FDA clearance for the investigational new drug application (IND) application of BRTX-100 submitted last month.
Image: Micrograph of showing a fragment of vertebral disc with degenerative changes. Photo: courtesy of Nephron/Wikipedia.