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

NCT07339111

This study is recruiting at 31 US sites in 16 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Knee Cartilage Defects

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
18 to 75 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Medipost, Inc.
Last updated on ClinicalTrials.gov
October 6, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Alabama · 1

  • Flourish Research Birmingham · Birmingham, AL

Arizona · 2

  • Scottsdale Clinical Trials, LLC - Elite Clinical Network · Scottsdale, AZ
  • AZ Orthopedic · Tempe, AZ

California · 6

  • TriWest Research Associates · El Cajon, CA
  • CORE Orthopaedic Medical Center · Encinitas, CA
  • Horizon Clinical Research - La Jolla · La Jolla, CA
  • Horizon Clinical Research · La Mesa, CA
  • Stanford University - Department of Orthopaedic Surgery · Redwood City, CA
  • Source Healthcare · Santa Monica, CA

Colorado · 2

  • Orthopedic Centers of Colorado · Parker, CO
  • Steamboat Orthopaedic and Spine Institute · Steamboat Springs, CO

Illinois · 1

  • Rush University Medical Center · Chicago, IL

Kentucky · 1

  • UK Orthopaedic Surgery & Sports Medicine - Turfland · Lexington, KY

Louisiana · 1

  • Ochsner Medical Center · Kenner, LA

Michigan · 2

  • University of Michigan · Ann Arbor, MI
  • Michigan Orthopedics and Spine Surgery · Rochester Hills, MI

Minnesota · 1

  • Mayo Clinic Rochester · Rochester, MN

New Jersey · 1

  • Curalta Clinical Trials · Westwood, NJ

New York · 1

  • New York Presbyterian Queens · Flushing, NY

North Carolina · 2

  • Atrium Health Mercy · Charlotte, NC
  • West Clinical Research · Morehead City, NC

Ohio · 2

  • University of Cincinnati Department of Orthopaedic Surgery · Cincinnati, OH
  • The Ohio State University Jameson Crane Sports Medicine Institute · Columbus, OH

Tennessee · 1

  • Helios Clinical Research · Jackson, TN

Texas · 6

  • Zenos Clinical Research · Dallas, TX
  • HD Research Corp. · Houston, TX
  • Memorial Hermann Center · Houston, TX
  • Futuro Clinical Trials · McAllen, TX
  • Endeavor Clinical Trials, P.A (ERG) · San Antonio, TX
  • Flourish Research San Antonio · San Antonio, TX

Utah · 1

  • JBR Clinical Research · Salt Lake City, UT

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.