Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Public ClinicalTrials.gov record NCT07339111. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Prospective, Double Blind, Multi-Center, Phase 3 Pivotal Clinical Trial to Compare Efficacy and Safety of CARTISTEM® and Surgical Comparator in Subjects With Knee Cartilage Lesions and Osteoarthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07339111
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 10, 2026
- Primary completion
- Jun 29, 2029
- Completion
- Jun 29, 2029
- Last update posted
- Sep 2, 2026
2026 – 2029
United States locations
- U.S. sites
- 28
- U.S. states
- 15
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Flourish Research Birmingham | Birmingham | Alabama | 35205 | Recruiting |
| Scottsdale Clinical Trials, LLC - Elite Clinical Network | Scottsdale | Arizona | 85260 | Recruiting |
| AZ Orthopedic | Tempe | Arizona | 85224 | Recruiting |
| TriWest Research Associates | El Cajon | California | 91910 | Recruiting |
| Horizon Clinical Research - La Jolla | La Jolla | California | 92122 | Recruiting |
| Horizon Clinical Research | La Mesa | California | 91924 | Recruiting |
| Source Healthcare | Santa Monica | California | 90403 | Recruiting |
| Orthopedic Centers of Colorado | Parker | Colorado | 80134 | Recruiting |
| Steamboat Orthopaedic and Spine Institute | Steamboat Springs | Colorado | 80487 | Recruiting |
| UK Orthopaedic Surgery & Sports Medicine - Turfland | Lexington | Kentucky | 40504 | Recruiting |
| Ochsner Medical Center | Kenner | Louisiana | 70065 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48106 | Recruiting |
| Michigan Orthopedics and Spine Surgery | Rochester Hills | Michigan | 48307 | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Recruiting |
| Curalta Clinical Trials | Westwood | New Jersey | 07662 | Recruiting |
| New York Presbyterian Queens | Flushing | New York | 11355 | Recruiting |
| Atrium Health Mercy | Charlotte | North Carolina | 28207 | Recruiting |
| West Clinical Research | Morehead City | North Carolina | 28557 | Recruiting |
| University of Cincinnati Department of Orthopaedic Surgery | Cincinnati | Ohio | 45267 | Recruiting |
| The Ohio State University Jameson Crane Sports Medicine Institute | Columbus | Ohio | 43202 | Recruiting |
| Helios Clinical Research | Jackson | Tennessee | 38305 | Recruiting |
| Zenos Clinical Research | Dallas | Texas | 75230 | Recruiting |
| Memorial Hermann Center | Houston | Texas | 77043 | Recruiting |
| HD Research Corp. | Houston | Texas | 77401 | Recruiting |
| Futuro Clinical Trials | McAllen | Texas | 78501 | Recruiting |
| Flourish Research San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Endeavor Clinical Trials, P.A (ERG) | San Antonio | Texas | 78240 | Recruiting |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07339111, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07339111 live on ClinicalTrials.gov.