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Phase I/IIa study to test the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint - BP CC 001
EU CTIS ID: 2024-517684-23-00
What this study is testing
Evaluation of the safety of the investigational product BP CC 001 (10 x 106 UC-MSC in 1 ml cell culture suspension) applied to a collagen support structure (Chondro-Gide®)
- Phase I and Phase II (Integrated)- First administration to humans
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
- Patients of any gender with an age of ≥ 18 years to ≤ 60 years
- 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
- Affected and contralateral knee (if known): Kellgren-Lawrence (K/L) osteoarthritis severity < grade III
- KOOS pain sub-score of ≤ 70 (out of max. 100) in the affected knee joint and > 80 (out of max. 100) in the contralateral knee joint measured without taking analgesics within the last 24 hours
- BMI < 35 kg/m²
You likely can't join if
- Known varus or valgus malalignment of the affected leg of ≥ 5°
- Previous fracture in the affected knee joint
- Osteoporosis
- Relevant concomitant diseases that increase the risk of surgery, e.g. heart failure, coronary heart disease, coagulation disorders, diabetes mellitus, liver cirrhosis, renal insufficiency, etc.
- History of hypersensitivity to porcine collagens, human albumin, glucose or components of fibrin adhesives used in orthopaedics or surgery
- Simultaneous participation in another interventional clinical trial (incl. within the last 4 weeks before inclusion)
See the full eligibility criteria
Who can join
- Patients of any gender with an age of ≥ 18 years to ≤ 60 years
- 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
- Affected and contralateral knee (if known): Kellgren-Lawrence (K/L) osteoarthritis severity < grade III
- KOOS pain sub-score of ≤ 70 (out of max. 100) in the affected knee joint and > 80 (out of max. 100) in the contralateral knee joint measured without taking analgesics within the last 24 hours
- BMI < 35 kg/m²
- Written informed consent
What rules you out
- Known varus or valgus malalignment of the affected leg of ≥ 5°
- Previous fracture in the affected knee joint
- Osteoporosis
- Relevant concomitant diseases that increase the risk of surgery, e.g. heart failure, coronary heart disease, coagulation disorders, diabetes mellitus, liver cirrhosis, renal insufficiency, etc.
- History of hypersensitivity to porcine collagens, human albumin, glucose or components of fibrin adhesives used in orthopaedics or surgery
- Simultaneous participation in another interventional clinical trial (incl. within the last 4 weeks before inclusion)
- Addictions or other illnesses that do not allow the person con-cerned to assess the nature and extent of the clinical trial and its possible consequences
- Any state that excludes adherence with the trial protocol (e.g. lack of compliance)
- Persons who are placed in an institution by court or official order
- Persons dependent on the sponsor
- Pregnant or breastfeeding women
- Antero-posterior or medio-lateral instability
- Women of childbearing potential, except women who meet one of the following criteria: a) post-menopausal (12 months natural amenorrhoea) b) postoperative (6 weeks after bilateral ovarectomy with or with-out hysterectomy, bilateral salpingectomy) c) negative pregnancy test (urine) and regular and correct use of a contraceptive method with an Pearl Index < 1% per year - Combined (oestrogen and progestogen-containing) hormonal contraception - Hormonal contraception containing progestogens (oral, injected, implanted) - IUD (hormonal IUD, copper IUD) d) sexual abstinance e) vasectomy of the partner
- Meniscus loss of more than 20% in the affected compartment
- Patella instability
- Simultaneous surgery on other joint structures (cruciate ligament replacement, meniscus suture, partial meniscus resection > 20%, osteotomy)
- Simultaneous higher-grade (ICRS grade III/IV) cartilage damage on the corresponding joint surfaces to the treated cartilage damage
- Intra-articular application of hyaluronic acid or glucocorticoids or thrombocyte concentrates within the last 6 months
- Joint replacement in the contra-lateral knee or hip within the last 12 months
- Rheumatoid arthritis or other inflammatory diseases such as autoimmune diseases, seronegative spondyloarthritis, gout, pseudogout
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.