Phase 3RecruitingAge-related condition
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. (Industry)
- Enrolment
- 300 planned
- Conditions
- Knee Cartilage Defects
- Interventions
- CARTISTEM® + Debridement; Debridement
- Ages
- adults, older adults
- Registry
- NCT07339111
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Visual Analog Scale (VAS) Pain Score
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Function score
History
Primary completion expected
Last registry update
Started
Registered