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

NCT06981741 | Recruiting Phase 1

• 2 other identifiers: MesemCart2Clinic - BP CC 0012024-517684-23-00
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Cartilage Damage

Keywords

knee; cartilage; mesenchymal stromal cells; mesenchymal stem cells; UC-MSC

Outcome Measures

Primary Outcomes (1)

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

  within 24 months after surgery

Secondary Outcomes (7)

• Regeneration of damaged cartilage measured using the MOCART score

  12 months after surgery

• Relative change in pain in the knee joint compared to the initial value before the operation measured using the KOOS Pain Subscore

  12 and 24 months after the operation

• Relative change in knee-related quality of life compared to pre-surgery baseline measured by KOOS-QoL subscore

  12 and 24 months after surgery

• Relative change in symptoms and stiffness compared to pre-surgery baseline as measured by KOOS symptom subscore

  12 and 24 months after surgery

• Relative change in activities of daily living compared to pre-surgery baseline measured by KOOS-ADL subscore

  12 and 24 months after surgery

Study Arms (1)

Investigational Product Arm

EXPERIMENTAL

Participants in this arm will undergo arthroscopic or minimally invasive knee surgery, during which the investigational product - mesenchymal stromal cells (MSCs) derived from umbilical cord tissue (MesemCart) - will be applied once directly to the cartilage defect. All patients will receive the same treatment and will be monitored for safety and initial efficacy outcomes over a period of 24 months.

Biological: BP CC 001

Interventions

BP CC 001 BIOLOGICAL

10-20 x 10\^6 UC-MSC in 1 ml suspension, applied to a collagen carrier structure (Chondro-Gide®)

Investigational Product Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of any gender with an age from ≥ 18 years to ≤ 60 years
• Clinical indication for a surgical cartilage regeneration procedure
• Symptomatic grade III/IV cartilage defect according to ICRS or osteochondral defect with a maximum depth of 3 mm
• A cartilage defect requiring treatment with a defect size of 2-6 cm² on the femoral condyles or patella or trochlea
• Affected and contralateral knee (if known): Kellgren-Lawrence (K/L) osteoarthritis severity \< grade III
• KOOS pain sub-score of ≤ 70 (out of max. 100) in the affected knee joint and \> 80 (out of max. 100) in the contralateral knee joint measured without taking analgesics within the last 24 hours
• BMI \< 35 kg/m²
• Written informed consent of the participant, also regarding alternative procedures such as cartilage transplantation (MACT) or matrix-augmented bone marrow stimulation (BMS, AMIC)

You may not qualify if:

• Clinical indication explicitly for a cartilage regeneration procedure other than the intended study treatment
• Known varus or valgus malalignment of the affected leg of ≥ 5°
• Antero-posterior or medio-lateral instability
• Meniscus loss of more than 20% in the affected compartment
• Patella instability
• Simultaneous surgery on other joint structures (cruciate ligament replacement, meniscus suture, partial meniscus resection \> 20%, osteotomy)
• Simultaneous higher-grade (ICRS grade III/IV) cartilage damage on the corresponding joint surfaces to the treated cartilage damage ("kissing lesions")
• Osteoarthritis Kellgren-Lawrence (K/L) grade III or IV
• Arthrofibrosis
• Metabolic arthropathy
• Collagenosis
• Autoimmune disease
• Tumor disease within the last 5 years
• Neuromuscular disease
• Peripheral arterial occlusive disease

Sponsors & Collaborators

• BIONCaRT GmbH: lead
• KKS Netzwerk: collaborator
• Fraunhofer Institute for Cell Therapy and Immunology IZI: collaborator
• Polski Bank Komorek Macierzystych JSC (PBKM): collaborator

Study Sites (7)

Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie

Altenburg, 04600, Germany

RECRUITING

St. Nikolaus Stifts-Hospital

Andernach, 56626, Germany

RECRUITING

Sozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie

Bamberg, 96049, Germany

RECRUITING

Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

RECRUITING

GFO Kliniken Niederrhein, St. Vinzenz Hospital Dinslaken

Dinslaken, 46535, Germany

RECRUITING

UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, 01307, Germany

RECRUITING

Maria-Josef-Hospital Greven, Klinik für Unfallchirurgie und Orthopädie

Greven, 48268, Germany

RECRUITING

Study Officials

• Jörg Lützner, Prof.Dr.med.

  UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus, TU Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Thamm, PhD

CONTACT

+491607697453; kristina.thamm@bioncart.com

Heike Opitz, PhD

CONTACT

+4917672515224; heike.opitz@bioncart.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

DE (7)