IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.

Phase 1

Completed

Conditions: Knee Pain Swelling
Foreign-Body Reaction
Inflammation
Effusion (L) Knee

Interventions: Other: Cartilage repair surgery

Registration Number: NCT02037204

Lead Sponsor: UMC Utrecht

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cartilage repair surgery	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.

Primary Outcome Measures

Name	Time	Method
Safety: Adverse Events	18 months	Adverse events rate

Secondary Outcome Measures

Name	Time	Method
Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score	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.