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

Conditions

• Knee Cartilage Defects

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• CARTISTEM® + Debridement — BIOLOGICAL
  CARTISTEM® + Debridement CARTISTEM® consists of approximately 7.5 x 106 hUCB-MSCs (human umbilical cord blood-derived mesenchymal stem/stromal cells) suspended in 1.5 ml medium in one vial, and 60 mg sodium hyaluronate provided as a lyophilized powder in a separate vial. A viscous and malleable gel matrix is formed by mixing hUCB-MSCs (main component) and 60mg of sodium hyaluronate at a 4% concentration (excipient).
• Debridement — PROCEDURE
  Debridement of unstable cartilage in and around cartilage lesion(s) in the knee.

Study Details

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.

Key Dates

First listed

Jan 14, 2026

Start date

Mar 11, 2026

Status verified

Sep 2026

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CARTISTEM + Debridement
  Participants in Group A will receive CARTISTEM + Debridement in the target knee.
• Active Comparator: Debridement
  Participants in Group B will receive debridement procedure.

Primary Outcome Measure

Visual Analog Scale (VAS) Pain Score [ Time Frame: From enrollment to end of follow-up at 24 months ]

Central Contacts

• Adrian Orr, VP Clinical Development
  617-575-2203
  [email protected]
• Luis Toro, Medical Monitor for IQVIA, MD

Locations (30)

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