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Tests treatment safety and results for Cartilage Damage
Official title Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint
ClinicalTrials.gov ID: NCT06981741
What this study is testing
What is BP CC 001?
BP CC 001 is an investigational medicine, being studied as a potential treatment for cartilage damage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Testing the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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
- Affected and contralateral knee (if known): Kellgren-Lawrence (K/L) osteoarthritis severity \< grade III
You likely can't join if
- 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
- Patella instability
- Simultaneous surgery on other joint structures (cruciate ligament replacement, meniscus suture, partial meniscus resection \> 20%, osteotomy)
See the full eligibility criteria
- 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
- 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 of the participant, also regarding alternative procedures such as cartilage transplantation (MACT) or matrix-augmented bone marrow stimulation (BMS, AMIC)
- 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
- 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 ("kissing lesions")
- Osteoarthritis Kellgren-Lawrence (K/L) grade III or IV
- Arthrofibrosis
- Metabolic arthropathy
- Collagenosis
- Autoimmune disease
- Tumor disease within the last 5 years
- Neuromuscular disease
- Peripheral arterial occlusive disease
- Intra-articular application of hyaluronic acid or glucocorticoids or platelet 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
- Previous fracture in the affected knee joint
- Osteoporosis
- Contraindications against the planned operation under general anesthesia
- Relevant secondary diseases that increase the risk of surgery, e.g. cardiac insufficiency, coronary heart disease, coagulation disorders, diabetes mellitus, liver cirrhosis, renal insufficiency, etc.
- History of known hypersensitivity to porcine collagens, human albumin, glucose or components of fibrin adhesives used in orthopaedics or surgery
- Simultaneous participation in another treatment clinical trial (incl. within the last 4 weeks prior to inclusion)
- Addiction or other illnesses that do not allow the person concerned to assess the nature, scope and possible consequences of the clinical trial (lack of capacity to consent)
- Indications that the patient is unlikely to adhere to the protocol (e.g. lack of compliance)
- Persons who are placed in an institution by court or official order
- Persons who are dependent on the sponsor
- Pregnant or breastfeeding women
- Women of childbearing age, except women who meet the following criteria:
- Post-menopausal (12 months natural amenorrhea)
- Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy or bilateral salpingectomy)
- Presence of a negative pregnancy test (urine, not older than 14 days on the day of surgery) and willingness to regularly and correctly use a contraceptive method with a Pearl Index \< 1 % per year: 3.1 Combined...
- Sexual abstinence
- Vasectomy of the partner
The study team makes the final eligibility decision.
Where it's taking place
- Altenburg, Germany
- Andernach, Germany
- Bamberg, Germany
- Berlin, Germany
- Dinslaken, Germany
- Dresden, Germany
- Greven, Germany
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 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Altenburg, Germany; Andernach, Germany; Bamberg, Germany; Berlin, Germany; Dinslaken, Germany; Dresden, Germany and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.