Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

November 15, 2021

Primary Completion Date

December 16, 2022

Study Completion Date

January 16, 2023

Conditions
Articular Cartilage Disorder of KneeCartilage DamageMicrofractures
Interventions
BIOLOGICAL

microfracture surgery + HST003

This is an Intervention Model where all patients who are identified/confirmed candidates for microfracture surgery will be enrolled to receive the microfracture surgery (standard of care). Ten (10) patients will be randomized to receive the study intervention (HST003). HST003 will be injected into the microfracture defects (interstices) and fill the remainder of the defect to the cartilage margin following surgery. The primary purpose of the study is to compare the two groups: microfracture surgery + HST003 as compared to the microfracture surgery only group.

Trial Locations (5)

16801

Site 005, State College

20814

Site 001, Bethesda

34209

Site 003, Bradenton

77027

Site 004, Houston

81657

Site 002, Vail

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Histogen

INDUSTRY