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NCT05079035 · ClinicalTrials.gov registry record · Phase 2
Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord (TTAX03) for KL Grade 3-4 Knee OA
A Phase 2 study, sponsored by BioTissue Holdings.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT05079035 is a Phase 2 study that has completed, run by BioTissue Holdings. The registered enrollment target is 90 participants.
The verdict
NCT05079035, a Phase 2 study, has completed, sponsored by BioTissue Holdings.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
It is hypothesized that a single Intra-articular Injection of TTAX03, 100mg in 2mL of saline, will have more benefit with respect to the proportion of responders 12 weeks post-injection than an equal volume of saline, based on the OMERACT-OARSI responder criteria.
Interventions
- BIOLOGICAL Saline
- BIOLOGICAL TTAX03
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-12-06 |
| Est. Completion | 2025-03-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05079035
The ClinicalTrials.gov registry entry for NCT05079035 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioTissue Holdings, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT05079035 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05079035 about?
NCT05079035 is a clinical study titled "Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord (TTAX03) for KL Grade 3-4 Knee OA". It is hypothesized that a single Intra-articular Injection of TTAX03, 100mg in 2mL of saline, will have more benefit with respect to the proportion of responders 12 weeks post-injection than an equal volume of saline, based on the OMERACT-OARSI responder criteria.
What is the current status of trial NCT05079035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2021-12-06. Estimated completion is 2025-03-07.
What interventions are being tested in trial NCT05079035?
The interventions under investigation include: Saline (BIOLOGICAL), TTAX03 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05079035?
This trial is sponsored by BioTissue Holdings, which has 13 total clinical trials registered on ClinicalTrials.gov.
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