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NCT07339111 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
A Phase 3 study of Knee Cartilage Defects, sponsored by Medipost.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 13
- Study locations
NCT07339111: Recruiting Phase 3 study of Knee Cartilage Defects, sponsored by Medipost.
NCT07339111 is a Phase 3 study of Knee Cartilage Defects that is actively recruiting participants, run by Medipost. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07339111, a Phase 3 study of Knee Cartilage Defects, is actively recruiting participants, sponsored by Medipost.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 13
- Study locations
Study Summary
To establish the efficacy and safety of CARTISTEM®, a combination product composed of allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) formulated with a cross-linked sodium hyaluronate (HA) hydrogel, CARTISTEM® compared to the surgical comparator of debridement in Subjects with knee cartilage lesions and osteoarthritis. This trial is intended to provide evidence of the superiority of CARTISTEM® to reduce knee pain and improve knee function compared to debridement for Subjects with knee cartilage lesions and osteoarthritis at 2-years post-treatment. Additionally, this trial is intended to intended to explore whether CARTISTEM® may have disease-modifying effects on osteoarthritis progression through the use of semi-quantitative MRI assessment.
Primary Outcome
Change from Baseline Visual Analog Scale (VAS) Pain score (0-100 point scale, 0 being no pain at one end and 100 being the worst imaginable pain at the other) in index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.
Conditions Studied
Interventions
- BIOLOGICAL CARTISTEM® + Debridement
- PROCEDURE Debridement
Study Locations (13)
Texas
- Zenos Clinical Research - Dallas
- Memorial Hermann Center - Houston
- HD Research Corp. - Houston
- Flourish Research San Antonio - San Antonio
California
- TriWest Research Associates - El Cajon
- Horizon Clinical Research - La Mesa
- Source Healthcare - Santa Monica
Alabama
- Flourish Research Birmingham - Birmingham
Arizona
- AZ Orthopedic - Tempe
Colorado
- Steamboat Orthopaedic and Spine Institute - Steamboat Springs
New Jersey
- Curalta Clinical Trials - Westwood
North Carolina
- West Clinical Research - Morehead City
Utah
- JBR Clinical Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2026-03-11 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
What NCT07339111 shows while recruiting
NCT07339111 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Knee Cartilage Defects appearing as the primary indexed condition, and to 2 interventions - of which CARTISTEM® + Debridement is the first listed.
NCT07339111 lists 13 locations in 8 states (Texas, California, Alabama).
Frequently Asked Questions
What is clinical trial NCT07339111 about?
NCT07339111 is a clinical study titled "Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis". To establish the efficacy and safety of CARTISTEM®, a combination product composed of allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) formulated with a cross-linked sodium hyaluronate (HA) hydrogel, CARTISTEM® compared to the surgical comparator of debridement in Sub...
What is the current status of trial NCT07339111?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2026-03-11. Estimated completion is 2029-06-30.
What conditions does trial NCT07339111 study?
This clinical trial studies the following conditions: Knee Cartilage Defects.
What interventions are being tested in trial NCT07339111?
The interventions under investigation include: CARTISTEM® + Debridement (BIOLOGICAL), Debridement (PROCEDURE).
Who is sponsoring clinical trial NCT07339111?
This trial is sponsored by Medipost, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07339111 being conducted?
This trial has 13 study locations across Alabama, Arizona, California, Colorado, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07339111's enrollment target sits among peer trials
300 1123rd of 2000 higher than 840 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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