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Efficacy of bone marrow-derived stem cells in treatment of knee cartilage defects.
EU CTIS ID: 2023-503486-32-00
What this study is testing
Efficacy: To compare the treatment efficacy of a combination of conventional microfracture and autologous MSC seeded onto the acellular 3D scaffold as compared to the commonly used method of microfracture and application of the scaffold alone, in subjects with knee joint chondral lesion.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients of either sex, age between 18 and 55 years.
- Able to provide written informed consent.
- Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage II (according to Kellgren classification), the cause of the defect being either trauma or incipient degeneration.
- Defect is located in the weigh-bearing part of femoral condyle.
- Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture of the subchondral bone followed by the application of a 3D scaffold).
- Isolated chondral defect with a maximum size of 6 cm2.
You likely can't join if
- Axial deformities over 10° on the study knee.
- Systemic corticoid or immunosuppressive medication, or anticoagulant therapy, ongoing or recent, (used regularly during the last 3 months before the planned knee surgery). Intraarticular corticoid medication is not allowed within the same time period.
- Active infection or any other condition limiting the healing (e.g., immunodeficiency, hepatitis, active tuberculosis, neoplasm, diabetes and other serious metabolic disorders, drug abuse, etc.).
- Concurrent or previous cancer.
- Blood, plasma or platelet transfusion during previous 8 weeks.
- Pregnant or lactating women.
See the full eligibility criteria
- Adult patients of either sex, age between 18 and 55 years.
- Able to provide written informed consent.
- Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage II (according to Kellgren classification), the cause of the defect being either trauma or incipient degeneration.
- Defect is located in the weigh-bearing part of femoral condyle.
- Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture of the subchondral bone followed by the application of a 3D scaffold).
- Isolated chondral defect with a maximum size of 6 cm2.
- No previous knee surgery due to a treatment of a chondral defect.
- Preoperative level of hemoglobin at least 110 g per L.
- Preoperative level of platelet count higher than 150 000 per mL.
- Sexually active, nonsterile female patients need to use highly effective contraception during the whole study.
- Axial deformities over 10° on the study knee.
- Systemic corticoid or immunosuppressive medication, or anticoagulant therapy, ongoing or recent, (used regularly during the last 3 months before the planned knee surgery). Intraarticular corticoid medication is not allowed within the same time period.
- Active infection or any other condition limiting the healing (e.g., immunodeficiency, hepatitis, active tuberculosis, neoplasm, diabetes and other serious metabolic disorders, drug abuse, etc.).
- Concurrent or previous cancer.
- Blood, plasma or platelet transfusion during previous 8 weeks.
- Pregnant or lactating women.
- BMI higher than 40.
- Clinical instability of the knee joint.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.