Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis (CARTISTEM23-01)
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.
A observational or N/A phase clinical study on Knee Cartilage Defects, this trial is actively recruiting participants. The trial is conducted by Medipost, Inc. and has accumulated 3 data snapshots since 2026. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
3 versions recorded-
Apr 17, 2026 — Present [daily]
Recruiting
Status: Not Yet Recruiting → Recruiting · Phase: PHASE3 → None
-
Mar 2026 — Apr 2026 [monthly]
Not Yet Recruiting PHASE3
-
Feb 2026 — Mar 2026 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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.
Contact Information
- Medipost, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .