RecruitingPhase 3

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

United States300 participantsStarted 2026-03-11

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 and ≤ 75 years old.
✓. Knee Osteoarthritis diagnosed in the index knee according to the clinical definition of American College of Rheumatology (ACR) guidelines at screening.
✓. Failed conservative knee osteoarthritis treatment for at least 3 months prior to consent (weight reduction, physical therapy, injections, pain medications, etc.).
✓. Kellgren-Lawrence (KL) in the index knee of grade 2 to 3 as determined by independent radiologist review of study X-Ray.
✓. Clinically relevant femoral cartilage defects classified using modified Outerbridge Grade 3 or 4 in index knee with combined lesion area ≥ 2 cm2 and ≤ 9 cm2 and at least a single femoral lesion ≥ 2 cm2 as determined by independent radiologist review of study MRI.
✓. Body Mass Index (BMI) ≤ 35 kg / m2 .
✓. VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at screening.
✓. VAS PAIN contralateral knee score ≤ 30 based on 100-point scale at screening.

Exclusion criteria

What they're measuring

Visual Analog Scale (VAS) Pain Score

Timeframe: From enrollment to end of follow-up at 24 months

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Function score

Timeframe: From start of treatment to the end of follow-up at 24 months

Trial details

NCT IDNCT07339111

SponsorMedipost, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06-30

Contact for this trial

Adrian Orr, VP Clinical Development

617-575-2203 cartistem2023-01@medi-post.com

View on ClinicalTrials.gov More Knee Cartilage Defects trials