Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05082831 · ClinicalTrials.gov registry record · Phase 1
Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage
A Phase 1 study, sponsored by Histogen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT05082831: Clinical Trial Phase 1 study, sponsored by Histogen.
NCT05082831 is a Phase 1 study that was terminated before completion, run by Histogen. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05082831, a Phase 1 study, was terminated before completion, sponsored by Histogen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The KOOS (Knee Injury and Osteoarthritis Outcome Score) questionnaire will be completed at Screening (only questions 5-9 of the pain sub-form) and at Day 0 (before surgery), 42, 84, 168 and 365. Change from baseline in the KOOS pain sub-score will be compared between the study and control groups to test the hypothesis that use of HST003 in arthroscopic microfracture surgery is associated with an equal or lesser pain score than control. The questionnaire has five separately scored subscales: Pain
Interventions
- BIOLOGICAL microfracture surgery + HST003
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2023-01-16 |
| Phase | Phase 1 |
Why NCT05082831 stopped before completion
NCT05082831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which microfracture surgery + HST003 is the first listed.
NCT05082831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05082831 about?
NCT05082831 is a clinical study titled "Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage". 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 c...
What is the current status of trial NCT05082831?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2021-11-15. Estimated completion is 2023-01-16.
What interventions are being tested in trial NCT05082831?
The interventions under investigation include: microfracture surgery + HST003 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05082831?
This trial is sponsored by Histogen, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05082831's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI