RecruitingPhase 1Phase 2NCT06981741

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

Sponsor

BIONCaRT GmbH

Enrollment

55 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

Cartilage Damage

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria8

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 Criteria36

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:
Post-menopausal (12 months natural amenorrhea)
Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy or bilateral salpingectomy)
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:
Combined (oestrogen and progestogen-containing) hormonal contraception 3.2 Hormonal contraception containing progestogens (oral, injected, implanted) 3.3 IUD (hormonal IUD, copper IUD)
Sexual abstinence
Vasectomy of the partner