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Terminated Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT05082831

Public ClinicalTrials.gov record NCT05082831. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Human Extracellular Matrix Implanted in the Bone Interstices & the Cartilage Defect Following Arthroscopic Microfracture Surgery in the Knee,in Comparison to Microfracture Surgery Alone

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

HST003 is a human extracellular matrix designed for injection into the subchondral bone following microfracture surgery by an injection into the interstices created by the surgical awl and filling the full defect to help restore-regenerate hyaline cartilage to a pre-injury state. In this Phase 1/2 clinical trial, we will be addressing the knee joint in conjunction with microfracture surgery. HST003 is human extracellular matrix secreted by human dermal fibroblasts under hypoxic conditions. The various matrix proteins produce a combination structural scaffold in addition to the natural secreted glycoproteins such as lubricin, fibronectin, laminins, hyaluronic acid, and collagens - all critical components of cartilage, particularly hyaline cartilage. This Phase 1/2 study will help design additional studies to support FDA approval for the use of HST003 in focal cartilage defects in the knee resulting from recent traumatic injury.

Study identification

NCT ID
NCT05082831
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Histogen
Industry
Enrollment
1 participant

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 15, 2021 (Actual)
Primary completion
Dec 16, 2022 (Actual)
Completion
Jan 16, 2023 (Actual)
Last update posted
Jan 19, 2023

2021 – 2023

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Site 002 Vail Colorado 81657 —
Site 003 Bradenton Florida 34209 —
Site 001 Bethesda Maryland 20814 —
Site 005 State College Pennsylvania 16801 —
Site 004 Houston Texas 77027 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05082831, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 19, 2023 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05082831 live on ClinicalTrials.gov.

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