Introduction of ACI for Cartilage Repair
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|ClinicalTrials.gov Identifier: NCT04296487|
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : March 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Articular Cartilage Defect Chondral Defect Osteochondritis||Other: autologous chondrocytes||Not Applicable|
- Prospective and interventional study
- All procedures are carried out after obtaining informed written consent from patients.
- Study procedures involve a biopsy, cell production, cell implantation and follow-up including a strict post-surgery rehabilitation protocol (12 month timepoint)
- All subjects will be assessed at intervals post-implantation (6 weeks, 3 months, 6 months and 12 months).
- Measures to assess effectiveness and safety will be conducted at follow-ups: Magnetic Resonance Imaging (MOCART score), collection of adverse events, orthopaedic scores (KOOS, IKDC, SF12v2)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2025|
|Estimated Study Completion Date :||September 1, 2025|
Experimental: Autologous Chondrocyte Injection
Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10^6 of cells per cm^2 of the cartilage defect.
Other: autologous chondrocytes
autologous chondrocytes implantation (ACI)
- Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs) [ Time Frame: Up to 12 months. ]Post-implantation data collection: Types, probability and severity of treatment (inflammation, infection,pain, joint effusion, delamination, transplant rejection, fibrocartilage, incomplete cartilage reparation).
- Change in tissue integrity into and around the treated aera [ Time Frame: 3 months post-implantation ]MRI analysis
- Absence of infection after implantation. [ Time Frame: 6 weeks post-implantation ]Absence of infection is assessed in blood sample by the quantification of three parameters: C-reactive Protein (CRP), neutrophil and lymphocyte rate. The non-infection is characterised by a CRP rate < 10 mg/L, neutrophil rate ranges from 40-75% and lymphocyte rate ranges from 25-40%.
- Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Change from baseline to 12 months post-implantation. ]KOOS includes five subscales: symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score).
- Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC) [ Time Frame: Change from baseline to 12 months post-implantation ]A score will be calculated, and it ranges from 0 (worst score) to 100 (best score).
- Self-reported functional health and weel-being as assessed by SF12 Survey [ Time Frame: Change from baseline to 12 months post-implantation ]SF12 survey includes 2 subscales: mental component summary (MCS) and physical component summery (PCS). A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score).
- The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system. [ Time Frame: Change from baseline to12 months post-implantation ]MOCART scoring system is based on MRI analysis. A score in points will be calculated, and it ranges from 0 points (no repair) to 100 points (excellent cartilage defect repair)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04296487
|Contact: Robin MARTIN, MD||021 314 76 79 ext firstname.lastname@example.org|
|Contact: Virginie PHILIPPE, Ph-D||021 314 90 18 ext email@example.com|
|Centre Hospitalier Universitaire Vaudois - CHUV||Recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Robin MARTIN, MD 021 314 76 79 ext 41 firstname.lastname@example.org|
|Dr Robin MARTIN||Recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Robin Martin, MD 021 314 76 79 ext 41 email@example.com|
|Principal Investigator:||Robin MARTIN, MD||CHUV|