Clinical trial NCT06981741: Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cartilage Damage
Keywords: knee
cartilage
mesenchymal stromal cells
mesenchymal stem cells
UC-MSC
Lead sponsor: BIONCaRT GmbH
Sponsor class: INDUSTRY
Collaborators: name: KKS Netzwerk
name: Fraunhofer Institute for Cell Therapy and Immunology IZI
name: Polski Bank Komorek Macierzystych JSC (PBKM)
First posted: 2025-05-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: All patients who provide written informed consent after receiving detailed information about the study and its potential risks will undergo a screening to assess eligibility. This is a prospective, multicenter, single-arm, open-label clinical trial. On Visit 1 (Day 0), eligible patients will receive knee surgery with a one-time application of the investigational product to the cartilage defect. Follow-up visits over a two-year period will be conducted at regular intervals to monitor the safety of the investigational product and to collect initial data on its efficacy.

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

Primary outcomes:
measure: Proportion of patients with a serious adverse event within 24 months after surgery
timeFrame: within 24 months after surgery
Secondary outcomes:
measure: Regeneration of damaged cartilage measured using the MOCART score
timeFrame: 12 months after surgery
measure: Relative change in pain in the knee joint compared to the initial value before the operation measured using the KOOS Pain Subscore
timeFrame: 12 and 24 months after the operation
measure: Relative change in knee-related quality of life compared to pre-surgery baseline measured by KOOS-QoL subscore
timeFrame: 12 and 24 months after surgery
measure: Relative change in symptoms and stiffness compared to pre-surgery baseline as measured by KOOS symptom subscore
timeFrame: 12 and 24 months after surgery
measure: Relative change in activities of daily living compared to pre-surgery baseline measured by KOOS-ADL subscore
timeFrame: 12 and 24 months after surgery
measure: Relative change in physical resilience during sporting activities after the operation compared to the initial value before the operation measured using the KOOS-Sport/Rec-Subscore
timeFrame: 12 and 24 months
measure: Description of all adverse events (AE, AR, SAE, SAR, SUSAR) with regard to severity (assessed according to NCI-CTCAE V 5.0), causality, outcome
timeFrame: within 24 months after surgery
Other outcomes:
Locations:
city: Andernach
country: Germany
facility: St. Nikolaus Stifts-Hospital
city: Berlin
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
city: Dinslaken
country: Germany
facility: St. Vinzenz Hospital Dinslaken
city: Dresden
country: Germany
facility: UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden
Study officials:
affiliation: UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus, TU Dresden
name: Jörg Lützner, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: