Testing the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
10-20 x 10\^6 UC-MSC in 1 ml suspension, applied to a collagen carrier structure (Chondro-Gide®)
Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie
Altenburg, Germany
RECRUITINGSt. Nikolaus Stifts-Hospital
Andernach, Germany
RECRUITINGSozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie
Proportion of patients with a serious adverse event within 24 months after surgery
Time frame: within 24 months after surgery
Regeneration of damaged cartilage measured using the MOCART score
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.
Time frame: 12 months after surgery
Relative change in pain in the knee joint compared to the initial value before the operation measured using the KOOS Pain Subscore
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.
Time frame: 12 and 24 months after the operation
Relative change in knee-related quality of life compared to pre-surgery baseline measured by KOOS-QoL subscore
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.
Time frame: 12 and 24 months after surgery
Relative change in symptoms and stiffness compared to pre-surgery baseline as measured by KOOS symptom subscore
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.
Time frame: 12 and 24 months after surgery
Relative change in activities of daily living compared to pre-surgery baseline measured by KOOS-ADL subscore
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.
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Bamberg, Germany
Evangelisches Waldkrankenhaus Spandau
Berlin, Germany
RECRUITINGGFO Kliniken Niederrhein, St. Vinzenz Hospital Dinslaken
Dinslaken, Germany
RECRUITINGUniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany
RECRUITINGMaria-Josef-Hospital Greven, Klinik für Unfallchirurgie und Orthopädie
Greven, Germany
RECRUITINGTime frame: 12 and 24 months after surgery
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
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.
Time frame: 12 and 24 months
Description of all adverse events (AE, AR, SAE, SAR, SUSAR) with regard to severity (assessed according to NCI-CTCAE V 5.0), causality, outcome
Time frame: within 24 months after surgery