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

NCT07339111 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-08

No results posted yet for this 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.

Conditions

  • Knee Cartilage Defects

Interventions

BIOLOGICAL

CARTISTEM® + Debridement

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).

PROCEDURE

Debridement

Debridement of unstable cartilage in and around cartilage lesion(s) in the knee.

Sponsors & Collaborators

  • Medipost, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07339111 on ClinicalTrials.gov