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 groupLocations
7Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie04600, Altenburg Germany
St. Nikolaus Stifts-Hospital56626, Andernach Germany
Sozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie96049, Bamberg Germany
Evangelisches Waldkrankenhaus Spandau13589, Berlin Germany
Sponsors 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