Overview

This trial is active, not recruiting.

Conditions foreign-body reaction, inflammation, effusion (l) knee, knee pain swelling
Treatment cartilage repair surgery
Phase phase 1/phase 2
Sponsor UMC Utrecht
Start date March 2013
End date July 2014
Trial size 35 participants
Trial identifier NCT02037204, IMPACT

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single-stage cartilage repair surgery using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
cartilage repair surgery Single-stage
Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs

Primary Outcomes

Measure
Safety
time frame: Multiple time points up to 18 months

Secondary Outcomes

Measure
Clinical improvement
time frame: 18 months

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

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.
Principal investigator Daniel B.F. Saris, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by UMC Utrecht.