Skip to content

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 - BP CC 001

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517684-23-00
Enrollment
55
Registered
2025-04-24
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage defect of the knee joint

Brief summary

Proportion of patients with a serious adverse event within 24 months after surgery

Detailed description

Regeneration of damaged cartilage measured by MOCART score (relative change in the value 12 months after surgery compared to the initial value before surgery), Relative change in knee joint pain 12 and 24 months after the surgery compared to the baseline value before the surgery measured using the KOOS Pain Subscore, Relative change in knee-related quality of life 12 and 24 months after surgery compared to baseline before surgery measured by KOOS-QoL subscore, Relative change in symptoms and stiffness 12 and 24 months after surgery compared to pre-surgery baseline as measured by KOOS symptom subscore, Relative change in activities of daily life 12 and 24 months after surgery compared to baseline before surgery measured by KOOS-ADL subscore, Relative change in physical resilience during sporting activities 12 and 24 months after the surgery compared to the baseline value before the surgery measured by KOOS-Excercise /Rec-Subscore, AE, AR, SAE, SAR, SUSAR: Description of all adverse events (AE, AR, SAE, SAR, SUSAR) within 24 months after surgery in terms of severity (assessed according to National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V 5.0)), causality, outcome

Interventions

Sponsors

BIONCaRT GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Proportion of patients with a serious adverse event within 24 months after surgery

Secondary

MeasureTime frame
Regeneration of damaged cartilage measured by MOCART score (relative change in the value 12 months after surgery compared to the initial value before surgery), Relative change in knee joint pain 12 and 24 months after the surgery compared to the baseline value before the surgery measured using the KOOS Pain Subscore, Relative change in knee-related quality of life 12 and 24 months after surgery compared to baseline before surgery measured by KOOS-QoL subscore, Relative change in symptoms and stiffness 12 and 24 months after surgery compared to pre-surgery baseline as measured by KOOS symptom subscore, Relative change in activities of daily life 12 and 24 months after surgery compared to baseline before surgery measured by KOOS-ADL subscore, Relative change in physical resilience during sporting activities 12 and 24 months after the surgery compared to the baseline value before the surgery measured by KOOS-Excercise /Rec-Subscore, AE, AR, SAE, SAR, SUSAR: Description of all adverse even

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026