Histogen Initiates Knee Cartilage Regeneration Trial

By Julie A. Vetalice

Histogen Initiates Knee Cartilage Regeneration Trial

Histogen announced the initiation of its Phase 1/2 clinical trial of HST 003 to evaluate the safety and efficacy of human extracellular matrix (hECM:HST 003) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure.

“The initiation of the HST 003 clinical trial as a treatment for regeneration of knee cartilage marks a major milestone for Histogen as we focus on developing best in class orthopedic therapeutics with our novel regenerative medicine platform technology,” said Richard W. Pascoe, Histogen’s President and CEO.

This double-blind placebo-controlled trial is designed to evaluate the safety and efficacy of hECM implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. Primary and secondary endpoints will include safety assessments, MRI to evaluate cartilage regeneration, and Knee Injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) scores to evaluate pain and joint function.

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.

Source: Histogen

Product Labels: Orthobiologic Soft Tissue Repair

Tags: Trial/Study