IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee. (IMPACT)
|ClinicalTrials.gov Identifier: NCT02037204|
Recruitment Status : Unknown
Verified July 2014 by D.B.F. Saris, UMC Utrecht.
Recruitment status was: Active, not recruiting
First Posted : January 15, 2014
Last Update Posted : July 18, 2014
|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)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|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 :||July 2014|
|Estimated Study Completion Date :||August 2015|
Experimental: Cartilage repair surgery
Single-stage cartilage repair surgery using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
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 [ Time Frame: Multiple time points up to 18 months ]Adverse event rate non-inferior to standard treatment (autologous chondrocyte implantation) and leads to no serious adverse events such as a immunological response.
- Clinical improvement [ Time Frame: 18 months ]Clinical improvement as measured by patient reported outcome scores.
- 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.
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|