Umbilical cord stem cells to treat knee cartilage damage

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

This will try a one-time surgical application of umbilical cord–derived mesenchymal stem cells to repair symptomatic cartilage defects in adults aged 18–60.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: BIONCaRT GmbH (industry)
• Locations: 7 sites (Altenburg and 6 other locations)
• Trial ID: NCT06981741 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, single-arm, open-label trial giving a one-time application of umbilical cord-derived mesenchymal stromal cells to a cartilage defect during knee surgery. Eligible adults with symptomatic focal grade III/IV cartilage or osteochondral defects (2–6 cm², ≤3 mm depth) will be treated and followed at regular intervals for two years. The trial focuses primarily on safety while collecting early data on symptom relief and cartilage repair. Patients with advanced osteoarthritis or other contraindications will be excluded to target a population suitable for cartilage regeneration procedures.

Who should consider this trial

Good fit: Adults 18–60 with symptomatic focal grade III/IV knee cartilage defects of 2–6 cm², BMI <35, Kellgren-Lawrence < III in the affected knee, and who are candidates for a surgical cartilage regeneration procedure are ideal candidates.

Not a fit: Patients with advanced or widespread osteoarthritis (Kellgren-Lawrence ≥ III), very large or deep defects outside the specified size/depth, BMI ≥35, or those indicated for alternative cartilage procedures are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the treatment could reduce pain and improve cartilage healing, potentially delaying or avoiding more invasive procedures like joint replacement.

How similar studies have performed: Small clinical series and early trials of mesenchymal stromal cells for knee cartilage have shown encouraging symptom and imaging signals, but larger randomized evidence is still limited.

Eligibility criteria

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

Where this trial is running

Altenburg and 6 other locations

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

Study contacts

• Principal investigator: Jörg Lützner, Prof.Dr.med. — UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus, TU Dresden
• Study coordinator: Kristina Thamm, PhD

Conditions: Cartilage Damage, knee, cartilage, mesenchymal stromal cells, mesenchymal stem cells, UC-MSC