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
Qualifiers
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
Treatments tested in this trial
- BP CC 001
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
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