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医学类干细胞与关节炎临床实验设计
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41. IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.. 1) Agency &Identifier Agency: D.B.F. Saris, UMC Utrecht (First received: January 13, 2014 Last updated: July 17, 2014 Last verified: July 2014) Identifier：NCT02037204 2) Purpose Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. Cartilage cell therapy using autologous chondrocyte implantation (ACI) has been established as the first advanced treatment therapy medicinal product. Although this technique has achieved good mid-term results, it is a costly and extensive two-stage procedure which is limited by the number of chondrocytes obtained by biopsy and the dedifferentiation resulting from the expansion phase. Therefore, there is a need for improvement. A new cartilage repair technique should aim at decreasing surgical trauma, lowering complexity, improving logistics and cost-effectiveness while retaining or improving clinical outcome. Direct contact between mesenchymal stromal cells (MSCs) and dedifferentiated articular chondrocytes in vitro showed improvement of the chondrogenic phenotype of dedifferentiated articular chondrocytes. In addition, preserving the pericellular matrix of chondrocytes improves cartilage formation. These chondrons (chondrocytes with their pericellular matrix) have shown improved cartilage formation when combined with allogeneic MSCs in extensive preclinical studies. The cells are mixed with fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. This will reduce patient morbidity and improve patient care through immediate transplantation of a potent cell-based cartilage product. This is a phase I/II prospective monocenter study to evaluate the safety and feasibility of the IMPACT for treatment of focal articular cartilage lesions of the knee. Condition Intervention Phase Foreign-Body Reaction Inflammation Effusion (L) Knee Knee Pain Swelling Other: Cartilage repair surgery Phase 1 Phase 2 Arms Assigned Interventions 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 Other Names: Single-stage Cartilage repair IMPACT 3) Criteria Inclusion Criteria: • Age >18 and <45 years old • Symptomatic isolated full-thickness articular cartilage lesion on the femoral condyle or trochlea. • Size 2 - 8 cm2 • Intact anterior cruciate ligament Exclusion Criteria: • (History of) osteoarthritis, defined as Kellgren-Lawrence grade >3 as determined from appropriate X-ray. • Concomitant inflammatory disease that affects the joint (rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis) • (History of) Septic arthritis. • Malalignment requiring an osteotomy. • (History of) total menisectomy in the target knee joint. • Any surgery in the knee joint 6 months prior to study inclusion. • Risk groups for MRI scanning due to the magnetic field like patients with pacemakers, nerve stimulators, metal particles, stents, clips or implants, (possible) pregnancy or breast feeding. • Patients with severe anxiety for MRI scans and/or needles 4) Outcome Measures Primary Outcome Measures: • Safety [ Time Frame: Multiple time points up to 18 months ] [ Designated as safety issue: Yes ] Adverse event rate non-inferior to standard treatment (autologous chondrocyte implantation) and leads to no serious adverse events such as a immunological response. Secondary Outcome Measures: • Clinical improvement [ Time Frame: 18 months ] [ Designated as safety issue: No ] Clinical improvement as measured by patient reported outcome scores. Other Outcome Measures: • Structural repair [ Time Frame: 12 months ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period. |
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