Randomized controlled trial comparing clinical outcomes of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee to conservative treatment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Utrecht

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

1 Dec 2024 → 21 Aug 2025

Decision date (initial)

2024-11-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514612-27-01

EudraCT number

2018-003470-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare the level of clinical improvement and quality of life between patients with cartilage defects treated with IMPACT to patients treated with standard care (optional physical therapy and pain medication, no surgical treatment) at 3, 6 and 9 months after randomization.

Conditions and MedDRA coding

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

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Symptomatic articular cartilage lesion of the knee (femoral condyles or trochlea)
2. Age >18 and <45 years old
3. 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.
4. Modified Outerbridge Grade III or IV isolated cartilage lesion of the knee.
5. A post-debridement size of the cartilage lesion > 2cm2 and ≤ 8 cm2
6. 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.
7. Stable knee ligaments (i.e. anterior and posterior cruciate ligaments).

Exclusion criteria 7

1. Malalignment of >5 degrees
2. (History of) osteoarthritis, defined as Kellgren-Lawrence grade >3 as determined from appropriate X-ray.
3. Concomitant inflammatory disease that affects the joint (rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis)
4. (History of) Septic arthritis.
5. (History of) Total meniscectomy in the target knee joint.
6. Any surgery in the knee joint for cartilage treatment 6 months prior to study inclusion.
7. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary study parameter will be the clinical improvement and quality of life after 3, 6 and 9 months as measured with, subscales of, the KOOS and the EQ5D, respectively

Secondary endpoints 1

1. The secondary objective of this study is to examine parameters of structural repair 6 and 18 months after treatment. This will be assessed using MRI-scans.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Utrecht

Sponsor organisation

Universitair Medisch Centrum Utrecht

Address

Heidelberglaan 100

City

Utrecht

Postcode

3584 CX

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

research coördinator

Public contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

research coördinator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications