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|
|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.
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|