NCT06981741

Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint

Phase I/IIa Study to Test the Safety and Efficacy of MSC From Umbilical Cord Tissue (UC-MSC) for the Treatment of Cartilage Damage in the Knee Joint

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: BIONCaRT GmbH · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Testing the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint

Detailed description

All patients who provide written informed consent after receiving detailed information about the study and its potential risks will undergo a screening to assess eligibility. This is a prospective, multicenter, single-arm, open-label clinical trial. On Visit 1 (Day 0), eligible patients will receive knee surgery with a one-time application of the investigational product to the cartilage defect. Follow-up visits over a two-year period will be conducted at regular intervals to monitor the safety of the investigational product and to collect initial data on its efficacy.

Conditions

• Cartilage Damage

Interventions

Type	Name	Description
BIOLOGICAL	BP CC 001	10-20 x 10\^6 UC-MSC in 1 ml suspension, applied to a collagen carrier structure (Chondro-Gide®)

Timeline

• Start date: 2025-11-10
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2025-05-21
• Last updated: 2026-01-13

Locations

7 sites across 1 country: Germany