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

Summary

This study will test whether CARTISTEM is safe and works better than debridement (a surgery that cleans out damaged tissue) for people with knee cartilage damage and osteoarthritis. CARTISTEM is a new treatment made of stem cells from donated umbilical cord blood mixed with a gel (hyaluronic acid) that is placed in the damaged area of the knee The main goal is to find out if CARTISTEM® reduces knee pain and improves knee function more than debridement two years after treatment. The study will also use MRI scans to explore whether CARTISTEM® may slow the worsening of osteoarthritis over time.

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 29, 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