Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint
ConditionCartilage Damage
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBIONCaRT GmbH
About this trial
Testing the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
BP CC 001
Biological/Vaccine10-20 x 10\^6 UC-MSC in 1 ml suspension, applied to a collagen carrier structure (Chondro-Gide®)
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Investigational Product ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with a serious adverse event within 24 months after surgery
Time frame
within 24 months after surgerySecondary outcomes
1
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 surgery2
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 operation3
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 surgery4
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
BIONCaRT GmbH
Lead sponsor
KKS Netzwerk
Collaborator
Fraunhofer Institute for Cell Therapy and Immunology IZI
Collaborator
Polski Bank Komorek Macierzystych JSC (PBKM)
Collaborator
Source ClinicalTrials.gov