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

Recruiting now · Phase 1/Phase 2

Conditions studied: Cartilage Damage

In brief

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

Key facts

Study ID

NCT06981741

Run by

BIONCaRT GmbH

People needed

55

Starts

2025-11-10

Expected to finish

2028-11-01

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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
• Intra-articular application of hyaluronic acid or glucocorticoids or platelet concentrates within the last 6 months
• Joint replacement in the contra-lateral knee or hip within the last 12 months
• Rheumatoid arthritis or other inflammatory diseases such as autoimmune diseases, seronegative spondyloarthritis, gout, pseudogout
• Previous fracture in the affected knee joint
• Osteoporosis
• Contraindications against the planned operation under general anesthesia
• Relevant secondary diseases that increase the risk of surgery, e.g. cardiac insufficiency, coronary heart disease, coagulation disorders, diabetes mellitus, liver cirrhosis, renal insufficiency, etc.
• History of known hypersensitivity to porcine collagens, human albumin, glucose or components of fibrin adhesives used in orthopaedics or surgery
• Simultaneous participation in another interventional clinical trial (incl. within the last 4 weeks prior to inclusion)
• Addiction or other illnesses that do not allow the person concerned to assess the nature, scope and possible consequences of the clinical trial (lack of capacity to consent)

Where it is running

• Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie — Altenburg, Germany (enrolling)
• St. Nikolaus Stifts-Hospital — Andernach, Germany (enrolling)
• Sozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie — Bamberg, Germany (enrolling)
• Evangelisches Waldkrankenhaus Spandau — Berlin, Germany (enrolling)
• GFO Kliniken Niederrhein, St. Vinzenz Hospital Dinslaken — Dinslaken, Germany (enrolling)
• UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany (enrolling)
• Maria-Josef-Hospital Greven, Klinik für Unfallchirurgie und Orthopädie — Greven, Germany (enrolling)

Full record on ClinicalTrials.gov

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