Histogen Awarded $2 Million Grant to Fund Knee Cartilage Regeneration Study

Histogen Inc., 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, has been awarded a $2 million grant by the Peer Reviewed Orthopedic Research Program (PRORP) of the U.S. Department of Defense (DoD) to help fund a Phase 1/2 clinical trial of HST-003 for regeneration of cartilage in the knee. The U.S. Army Medical Research Acquisition Activity is the awarding and administering acquisition office.
 
The Phase 1/2 clinical trial is designed to evaluate 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 clinical sites: OasisMD in San Diego; The Steadman Clinic in Vail, Colo., and Walter Reed Medical Center in Bethesda, Md. In addition to safety parameters, endpoints will include 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.
 
“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,” said Matthew Provencher M.D., Capt., MC, USNR. “Regenerating uniform functional hyaline cartilage is critical to restoring normal function for military personnel and civilians alike.”
 
“Lesions in articular knee cartilage can cause considerable morbidity and current surgical options may result in uneven repair and a scar-like fibrous cartilage instead of the normal hyaline cartilage that provides the greatest long-term function,” said Dr. Gail K. Naughton, Histogen founder and chief scientific officer. “Histogen’s HST-003 has demonstrated hyaline cartilage regeneration in three different in vivo animal models conducted by orthopedic experts. It is an honor to have been granted an award from the DoD to support our HST-003 Phase 1/2 trial.” 
 
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.ⁱ Further, among U.S. 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.ⁱⁱ
 
”These non-dilutive funds will support our efforts to clinically evaluate the safety and efficacy of our novel cartilage repair treatment which has applicability in both the military and civilian populations,” said Richard W. Pascoe, Histogen’s president and CEO. “As a former soldier, I understand that the health and readiness of our servicemembers is essential to our national defense. We are pleased to partner with the DoD and these prestigious clinical sites to advance HST-003 into the clinic in support of that effort.”
 
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.

References 
ⁱ Merkely, G., Ackermann, J. & Lattermann, C. Articular Cartilage Defects: Incidence, Diagnosis, and Natural History. Oper. Tech. Sports Med. 26, 156–161 (2018).
ⁱⁱ Teyhen, D. S., Goffar, S. L., Shaffer, S. W., Kiesel, K., Butler, R. J., Tedaldi, A.-M., Prye, J. C., Rhon, D. I. & Plisky, P. J. Incidence of Musculoskeletal Injury in US Army Unit Types: A Prospective Cohort Study. J. Orthop. Sports Phys. Ther. 48, 749–757 (2018).