Histogen Files Investigational New Drug Application for HST-003

By Julie A. Vetalice

Histogen Files Investigational New Drug Application for HST-003

Histogen submitted an Investigational New Drug application with FDA to initiate a U.S. Phase I/II clinical trial to evaluate human extracellular matrix HST-003 (hECM:HST-003) plus microfracture in the knee to regenerate hyaline cartilage.

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 has been shown to regenerate mature cartilage and well-vascularized bone, indicating therapeutic potential in sports medicine, spinal disc repair and orthopedic applications.

Earlier this year, the company was awarded a $2 million grant by the U.S. Department of Defense to help fund this Phase I/II clinical 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. Further, among U.S. military personnel, musculoskeletal injuries are a leading cause of morbidity, lost training time and reduced operational readiness.

"Assuming the HST-003 IND is approved, we anticipate initiating the Phase 1/2 trial in the first quarter of 2021 utilizing funding provided by the $2 million grant from the Department of Defense.” - Richard W. Pascoe, Histogen’s President and CEO.

Product Labels: PRP/Cell-Based/Osteoinductive Materials

Tags: Trial/Study