FDA Clinical Hold Removed for Histogen Trial in Knee Regeneration

Histogen confirmed that the company has satisfactorily addressed all clinical hold questions and can proceed with a planned Phase I/II clinical trial 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 microfracture.

The hold was announced in January 2021. The trial is expected to begin in 2Q21, supported by a $2 million grant from the U.S. Department of Defense.

Histogen’s hECM is intended for hyaline cartilage regeneration for the treatment of articular cartilage defects using a malleable scaffold that stimulates the body’s own stem cells. In preclinical models, HST-003 was shown to regenerate mature cartilage and well-vascularized bone, indicating therapeutic potential in sports medicine, spinal disc repair and orthopedic applications.