The U.S. Department of Defense (DOD) Peer Reviewed Orthopedic Research Program (PRORP) awarded $2 million to help fund a Phase 1/2 clinical trial testing HST-003 for regeneration of cartilage in the knee. Developed by Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company developing first-in-class restorative therapeutics that potentially ignite the body’s natural process to repair and maintain healthy biological function.
U.S Army Supports & Manages Innovation
Managed by the U.S. Army Medical Research Acquisition Activity at Fort Detrick, the funding contributes to the ongoing testing of innovative new regenerative life science-based technology. However, this news is generated by the company, Histogen, and the views don’t necessarily reflect those of the Department of the Army, Department of Defense and the U.S. Government.
There is a significant need for improved acute knee injury treatments in both military and civilian populations. Approximately 900,000 Americans are affected by knee cartilage injuries annually, with 200,000 requiring surgical intervention. Further, among US military personnel, musculoskeletal injuries are a leading cause of morbidity, lost training time and reduced operational readiness, resulting in as many as 2.4 million health visits and 25 million limited-duty days per year.
The Phase 1/2 clinical trial investigates HST-003 in combination with a microfracture procedure in 15 civilian and military patients with recent focal cartilage defects in the knee caused by injury. Patients will be enrolled at three trial sites, including OasisMD in San Diego, CA, The Steadman Clinic in Vail, CO and Walter Reed Medical Center in Bethesda, MD.
The study team will monitor safety parameters, endpoints and traditional scores for pain and joint function from The Knee Injury and Osteoarthritis Outcome Scores (KOOS) and The International Knee Documentation Committee (IKDC), as well as an MRI to quantify cartilage regeneration.
Matthew Provencher, MD, CAPT, MC, USNR, emphasized the high level of the trial site for this study, commenting, “The Steadman Clinic is world renowned for our dedication to excellence in treating orthopedic defects and we are excited about being a clinical center for studying Histogen’s human extracellular matrix, or hECM, for focal lesions of the knee.” He continued, “Regenerating uniform function hyaline cartilage is critical to restoring normal function for military personnel and civilians alike.”
What is HST-003?
Histogen’s human extracellular matrix, or hECM, is intended for regenerating hyaline cartilage for the treatment of articular cartilage defects with a novel malleable scaffold that stimulates the body’s own stem cells. In multiple preclinical models, HST-003 has been shown to regenerate mature cartilage and well vascularized bone, indicating great therapeutic potential in the sports medicine, spinal disc repair, orthopedic, and dental areas. Studies conducted by outside experts have demonstrated that HST-003 is anti-inflammatory, angiogenic, and can stimulate the growth of stem cells in damaged areas to induce tissue regeneration. The most extensive in vivo work in animals has focused on the regeneration of new hyaline cartilage and bone in full thickness knee injuries.
Histogen Inc. is a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function. Histogen’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen’s proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair.