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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 is a Phase 1 study that was terminated before completion, run by Histogen. The registered enrollment target is 1 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05082831
The ClinicalTrials.gov registry entry for NCT05082831 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Histogen, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which microfracture surgery + HST003 is the first listed.
NCT05082831 reports 0 study locations.
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.
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