IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee. (IMPACT)
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|ClinicalTrials.gov Identifier: NCT02037204|
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : January 2, 2019
Last Update Posted : January 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Foreign-Body Reaction Inflammation Effusion (L) Knee Knee Pain Swelling||Other: Cartilage repair surgery||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||First in man surgery: autologous chondrons are mixed with allogeneic MSCs and implanted in a fibrin glue carrier in a one-stage surgical procedure.|
|Masking:||None (Open Label)|
|Official Title:||Instant MSC Product Accompanying Autologous Chondron Transplantation (IMPACT): Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Cartilage repair surgery
Single-stage cartilage repair surgery using autologous chondrons (10-20%) and allogeneic MSCs (80-90%) in a fibrin glue carrier with a dosage of two million cells/ cm2 applied once during a surgical procedure.
Other: Cartilage repair surgery
Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs
- Safety: Adverse Events [ Time Frame: 18 months ]Adverse events rate
- Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 3 and 18 months ]Clinical improvement as measured by patient reported outcome scores. The questionnaire has been developed to evaluate the symptoms and limitations for patients with osteoarthritis. The outcome of the KOOS-scale varies from 0-100, where 0 indicates the greatest possible problems and is the worst outcome and 100 indicates no problems.
- Structural Repair [ Time Frame: 12 months ]To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.
- Health Care Use and Costs [ Time Frame: 18 months ]To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.
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): NCT02037204
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3508GA|
|Study Director:||Tommy S. de Windt, MD||UMC Utrecht|
|Principal Investigator:||Daniel B.F. Saris, MD, PhD||UMC Utrecht|