Cartilage Damage
Conditions
Keywords
knee, cartilage, mesenchymal stromal cells, mesenchymal stem cells, UC-MSC
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.
Interventions
BIOLOGICALBP CC 001
10-20 x 10\^6 UC-MSC in 1 ml suspension, applied to a collagen carrier structure (Chondro-Gide®)
Sponsors
KKS Netzwerk
Fraunhofer Institute for Cell Therapy and Immunology IZI
Polski Bank Komorek Macierzystych JSC (PBKM)
BIONCaRT GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a serious adverse event within 24 months after surgery | within 24 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in pain in the knee joint compared to the initial value before the operation measured using the KOOS Pain Subscore | 12 and 24 months after the operation | The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. |
| Relative change in knee-related quality of life compared to pre-surgery baseline measured by KOOS-QoL subscore | 12 and 24 months after surgery | The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. |
| Relative change in symptoms and stiffness compared to pre-surgery baseline as measured by KOOS symptom subscore | 12 and 24 months after surgery | The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. |
| Regeneration of damaged cartilage measured using the MOCART score | 12 months after surgery | The MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scoring system ranges from 0 to 100. A score of 0 indicates no repair, while 100 represents an excellent cartilage defect repair. |
| 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 | 12 and 24 months | The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. |
| Description of all adverse events (AE, AR, SAE, SAR, SUSAR) with regard to severity (assessed according to NCI-CTCAE V 5.0), causality, outcome | within 24 months after surgery | — |
| Relative change in activities of daily living compared to pre-surgery baseline measured by KOOS-ADL subscore | 12 and 24 months after surgery | The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. |
Countries
Germany
Contacts
Primary ContactKristina Thamm, PhD
Backup ContactHeike Opitz, PhD
Outcome results
None listed