Study on the IMPACT-treatment of cartilage defects (local damage to the cartilage) of the knee. In this treatment cells are obtained from the cartilage defect (from the damaged cartilage) and mixed with stromal cells from a donor. These cells are obtained and placed back in the defect during a single surgery. The primary goal of this study is to determine the effect of the IMPACT-treatment on pain and function of the knee.

Phase 1

• Conditions: Cartilage defect of the femoral condyle or trochlea; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-003470-27-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-19
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- 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
- 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to compare the level of clinical<br>improvement at 3, 6 and 9 months after treatment of a focal articular<br>cartilage lesion in the knee with IMPACT to the standard conservative treatment;Secondary Objective: The secondary objective is to evaluate structural cartilage tissue repair.<br>Other objectives are:<br>1. To evaluate clinical safety of the IMPACT therapy by active tracing of<br>the adverse event rate observed after IMPACT therapy and determining<br>if this is non-inferior to ACI treatment and does not lead to serious<br>adverse event i.e. a local or general immunological response.<br>2. To assess the healthcare use and costs related to the procedure as<br>well as the health-related work leave during the study period.;Primary end point(s): Clinical improvement and quality of life as measured with (subscales of)<br>the KOOS and the EQ5D, respectively;Timepoint(s) of evaluation of this end point: 3, 6, 9, 12 and 18 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary objective is structural repair of cartilage tissue in the<br>knee. This will be assessed by MRI at 6 and 18 months postoperatively.<br>For safety, a full, per patient, description of each AE will be recorded<br>including the nature, date and time of onset, date or resolution,<br>determination of seriousness, severity, action taken, outcome and<br>causality to study treatment. Specific AEs of interest will be filed in a<br>similar manner as AEs using separate scoring forms. If indicated, tissue<br>vigilance will be reported to the Transfusion Reaction in Patients (TRIP)<br>National Hemovigilance Office.<br>Healthcare use and costs related to the procedure as well as the healthrelated<br>work leave will be assessed using iMTA questionnaires.;Timepoint(s) of evaluation of this end point: 3, 6, 9, 12, and 18 months postoperatively