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CARTISTEM® for Knee Cartilage Lesions and Osteoarthritis

This study is testing a treatment called CARTISTEM® for knee cartilage damage and osteoarthritis. CARTISTEM® uses human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) combined with a gel. Researchers want to see if CARTISTEM® is better than a standard surgery called debridement (removing unstable cartilage) at reducing knee pain and improving how well your knee works. They will also look at whether CARTISTEM® can slow down the progression of osteoarthritis. You may be able to join if you are 18 to 75 years old, have knee osteoarthritis, and traditional treatments haven't worked for at least three months. The study aims to enroll 300 participants.

Study design
This interventional study compares CARTISTEM® plus debridement to debridement alone in 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after treatment to assess pain and knee function.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07339111

Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Medipost, Inc.
~300 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:CARTISTEM® + DebridementDebridement

At a glance

Recruiting sites
30 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visual Analog Scale (VAS) Pain Score
Measured over From enrollment to end of follow-up at 24 months
+1 more outcome measured

Conditions

Knee Cartilage Defects

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Knee Cartilage DefectsOsteoarthritis of knee

NCT07339111

Where you'd take part

This study runs at 30 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atrium Health Mercy

    Charlotte, North Carolinastudy coordinator listed

    Recruiting

  • AZ Orthopedic

    Tempe, Arizonastudy coordinator listed

    Recruiting

  • CORE Orthopaedic Medical Center

    Encinitas, Californiastudy coordinator listed

    Recruiting

  • Curalta Clinical Trials

    Westwood, New Jerseystudy coordinator listed

    Recruiting

  • Endeavor Clinical Trials, P.A (ERG)

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • Flourish Research Birmingham

    Birmingham, Alabamastudy coordinator listed

    Recruiting

  • Flourish Research San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • Futuro Clinical Trials

    McAllen, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Adrian Orr, VP Clinical Development
[email protected]
617-575-2203
Email the study team

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Eligibility criteria

Inclusion

Rescue medication (acetaminophen) allowed for break-through pain throughout the study.
Subjects must be willing to discontinue use of all pain medications at least 48 hours prior to baseline assessment and each follow up visit.
Limited postoperative NSAID use is permissible per IND clinical guidance and site manual, provided washout before scheduled efficacy assessments.
Post operative narcotics. 13. Subjects with stage 3 hypertension (systolic ≥ 180 mm Hg and diastolic ≥ 120 mmHg) must have blood pressure (BP) controlled prior to surgical procedure. 14. Subject's central lab results are within normal ranges or deemed as not clinically significant by investigator for CARTISTEM® treatment or surgical comparator. 15. Female Subjects of childbearing potential must agree to practice adequate methods of birth control to prevent pregnancy during the study. 16. Subjects must be able to comply fully with the rehabilitation requirements. 17. Subjects must be able to understand and comply with the requirements of the study. 18. Subjects must voluntarily provide written informed consent.

What this trial measures

  • Visual Analog Scale (VAS) Pain ScoreFrom enrollment to end of follow-up at 24 months

    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.

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Function scoreFrom start of treatment to the end of follow-up at 24 months

    Change from Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Function score (0-100 point scale, 0 being the best functioning and 100 being the worst functioning) in index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.