This study has been transitioned to CTIS with ID 2024-514612-27-01 check the CTIS register for the current data. The primary objective is to measure the level of clinical improvement and quality of life at 3, 6 and 9 months compared to…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to measure the level of clinical improvement and
quality of life at 3, 6, and 9 months compared to conservative treatment. This
is assessed by, subscales of, the KOOS and the EQ5D, respectively
Secondary outcome
The secondary objective is to measure functional repair using MRI at 6 and 18
months postoperative
Background 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 midterm results, it is a costly and extensive twostage procedure
which is limited by the number of chondrocytes obtained by biopsy and the
dedifferentiation resulting from the expansion phase. Therefore, it was
withdrawn from the European Market. There is a highly unmet need for treatment
of articular cartilag defect. A new cartilage repair technique should aim at
decreasing surgical trauma, lowering complexity, improving logistics and
costeffectiveness 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
MSCs. These cells can be mixed with a widely used, commercially available,
fibrin cell carrier and applied to the cartilage lesion within one surgical
procedure, using a minimally invasive and eventually arthroscopic technique. In
a phase I-II trial, we have shown that immediate transplantation of a potent
cellbased cartilage product is safe, reduces patient morbidity and improves
patient care. Therefore, we now propose the clinical evaluation in a phase
II-III randomized monocenter study of IMPACT for treatment of articular
cartilage defects of the knee to prove clinical safety and feasibility.
Study objective
This study has been transitioned to CTIS with ID 2024-514612-27-01 check the CTIS register for the current data.
The primary objective is to measure the level of clinical improvement and
quality of life at 3, 6 and 9 months compared to conservatively treated
patients. The secondary objective is to measure functional repair using MRI at
6 and 18 months postoperative.
Other important objectives are clinical safety and healthcare use and costs
related to the procedure as well as the healthrelated work leave during the
study period.
Study design
This is a phase III randomized controlled trial, comparing efficacy and safety
of a new ATMPproduct for isolated articular cartilage lesions to standard care
(conservative treatment). After 9 months patients in the control group are
allowed to cross over and receive IMPACT treatment.
Intervention
Onestage surgery using the Instant MSC Product accompanying Autologous Chondron
Transplantation (IMPACT)
Study burden and risks
Potential risks: graft failure and/ or migration or foreign body responce,
tissue hypertrophy (excessive growth of new tissue), and general knee surgery
related risks such as surgical site infection, arthralgia, joint crepitation,
swelling, effusion, chondropathy, synovitis, deepvein
thrombosis, pulmonary embolism, haemarthrosis and arthrofibrosis. See section
7.2 for definitions of AEs. At this moment, this is the only (therapeutic)
treatment option. The only alternative is physical therapy, which does not lead
to repair of the cartilage defect
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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 to 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).
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 for cartilage treatment, 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-514612-27-01 |
| EudraCT | EUCTR2018-003470-27-NL |
| CCMO | NL67161.000.18 |