NCT07339111

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Medipost, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-11
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2026-01-14
• Last updated: 2026-04-16

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study