Comparing Clinical Outcomes of the One-step Cartilage Transplantation in Cartilage Defects of the Knee With Conservative Treatment

• Status: Recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Articular cartilage defects in the knee have poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. Cartilage cell therapy using autologous chondrocyte implantation 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. 'Instant MSC Product accompanying Autologous Chondron Transplantation' (IMPACT) combines autologous recycled chondrons (chondrocytes surrounded by pericellular matrix) with MSCs for one-stage treatment of cartilage defects. IMPACT was successfully executed in a first-in-man phase I/II clinical trial in which 35 participants with cartilage defects were treated. The results showed a good safety profile, proper feasibility and good initial clinical efficacy at 18 months follow-up. Also good outcome at 24 and 36 months was shown in ongoing post study surveying of the participants. Consequently a new study with IMPACT was designed; IMPACT2. The objective of IMPACT2 is to compare clinical outcomes of 30 individual participants with cartilage defects treated with IMPACT to 30 participants treated with standard care for 9 months (consisting of optional physical therapy and pain medication). Participants should be aged 18-45 years with a symptomatic Modified Outerbridge Grade III or IV cartilage lesion of the knee ranging in size 2-8 cm^2.

After enrolment, participants will be allocated (randomized) to either group A in which case they receive IMPACT-treatment, or group B that will receive standard care. Standard care consists of optional physical therapy and pain medication. After 9 months, participants in group B can receive the IMPACT-procedure as well.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R.J.H. Custers
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development

Criteria

Inclusion Criteria:

Participants must meet the following criteria to be eligible for the study:

• Provides written informed consent, is able to understand the content of the study, understands the requirements for follow-up visits and is willing to provide the required information at follow-up visits and in the questionnaires.

• Symptomatic articular cartilage lesion of the knee (femoral condyles or trochlea).

• Age >18 and <45 years old

Inclusion criteria during surgery

• Participants must meet the following secondary criteria to be eligible for the study:

• Modified Outerbridge Grade III or IV isolated cartilage lesion of the knee.

• A post-debridement size of the cartilage lesion > 2cm2 and ≤ 8 cm2

• At least 50% of functional meniscus remaining. Meniscal repair or resection is allowed during the IMPACT surgery provided that the surgeon is able to confirm that at least 50% of functional meniscus remains.

• Stable knee ligaments (i.e. anterior and posterior cruciate ligaments).

Exclusion Criteria:

• Malalignment of >5 degrees

• (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.

• (History of) Total meniscectomy 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 participants with pacemakers, nerve stimulators, metal particles, stents, clips or implants, (possible) pregnancy or breast feeding.