Overview

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

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)
• Indications that the patient is unlikely to adhere to the protocol (e.g. lack of compliance)
• Persons who are placed in an institution by court or official order
• Persons who are dependent on the sponsor
• Pregnant or breastfeeding women
• Women of childbearing age, except women who meet the following criteria:
  1. Post-menopausal (12 months natural amenorrhea)
  2. Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy or bilateral salpingectomy)
  3. Presence of a negative pregnancy test (urine, not older than 14 days on the day of surgery) and willingness to regularly and correctly use a contraceptive method with a Pearl Index \< 1 % per year:

     3.1 Combined (oestrogen and progestogen-containing) hormonal contraception 3.2 Hormonal contraception containing progestogens (oral, injected, implanted) 3.3 IUD (hormonal IUD, copper IUD)

  4. Sexual abstinence
  5. Vasectomy of the partner