RecruitingPhase 3NCT07339111

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

Sponsor

Medipost, Inc.

Enrollment

300 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

Knee Cartilage Defects

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is comparing CARTISTEM, a stem cell therapy derived from donated umbilical cord blood combined with a hyaluronic acid gel, to a surgical cleaning procedure (debridement) for treating knee cartilage damage and osteoarthritis. The goal is to determine whether CARTISTEM provides superior pain relief and knee function improvement over 2 years and whether it may slow the progression of osteoarthritis. You may be eligible if you are 18 to 75 with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3), a cartilage defect of 2 to 9 cm2 on MRI, a BMI under 35, and knee pain scores in a moderate range, and have not responded adequately to at least 3 months of conservative treatment. Participation involves a single surgical procedure (either the stem cell injection or debridement), a structured rehabilitation program, and follow-up visits over 2 years. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCARTISTEM® + 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).

PROCEDUREDebridement

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

Locations(16)

Flourish Research Birmingham

Birmingham, Alabama, United States

AZ Orthopedic

Tempe, Arizona, United States

TriWest Research Associates

El Cajon, California, United States

Horizon Clinical Research

La Mesa, California, United States

Source Healthcare

Santa Monica, California, United States

Orthopedic Centers of Colorado

Parker, Colorado, United States

Steamboat Orthopaedic and Spine Institute

Steamboat Springs, Colorado, United States

Curalta Clinical Trials

Westwood, New Jersey, United States

Atrium Health Mercy

Charlotte, North Carolina, United States

West Clinical Research

Morehead City, North Carolina, United States

University of Cincinnati Department of Orthopaedic Surgery

Cincinnati, Ohio, United States

Zenos Clinical Research

Dallas, Texas, United States

Memorial Hermann Center

Houston, Texas, United States

HD Research Corp.

Houston, Texas, United States

Flourish Research San Antonio

San Antonio, Texas, United States

JBR Clinical Research

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT07339111