Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by BioTissue Holdings.
NCT05079035 is a Phase 2 study that has completed, run by BioTissue Holdings. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of subjects who, at the end of 12 weeks, report improvement from baseline in pain or in function \> or = 50% and absolute change \> or = 20; \- or - Improvement in at least 2 of the 3 following: * pain \> or = 20% and absolute change \> or = 10 * function \> or = 20% and absolute change \> or = 10 * global assessment \> or = 20% and absolute change \> or = 10
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 |
What the finished NCT05079035 record still lists
NCT05079035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT05079035 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05079035's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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 enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
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