Efficacy of bone marrow-derived stem cells in treatment of knee cartilage defects.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bioinova a.s.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

4 Feb 2021 → ongoing

Decision date (initial)

2024-11-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bioinova, a.s.

External identifiers

EU CT number

2023-503486-32-00

EudraCT number

2017-004143-21

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Efficacy: To compare the treatment efficacy of a combination of conventional microfracture and autologous MSC seeded onto the acellular 3D scaffold as compared to the commonly used method of microfracture and application of the scaffold alone, in subjects with knee joint chondral lesion.

Secondary objectives 1

1. Safety: To collect the data on the safety of autologous MSCs administration and thereby verify the positive results which have already been observed in other clinícal trials sponsored by Bioinova in this indication (OA-orMSCp-02; phase I/IIa) and in similar indications (e.g., treatment of bone damage after the revision hip arthroplasty); and in other clinical studies worldwide.

Conditions and MedDRA coding

Knee Cartilage Defect

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Adult patients of either sex, age between 18 and 55 years.
2. Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage II (according to Kellgren classification), the cause of the defect being either trauma or incipient degeneration.
3. Defect is located in the weigh-bearing part of femoral condyle.
4. Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture of the subchondral bone followed by the application of a 3D scaffold).
5. Isolated chondral defect with a maximum size of 6 cm2.
6. No previous knee surgery due to a treatment of a chondral defect.
7. Preoperative level of hemoglobin at least 110 g per L.
8. Preoperative level of platelet count higher than 150 000 per mL.
9. Sexually active, nonsterile female patients need to use highly effective contraception during the whole study.
10. Able to provide written informed consent.

Exclusion criteria 8

1. Axial deformities over 10° on the study knee.
2. Systemic corticoid or immunosuppressive medication, or anticoagulant therapy, ongoing or recent, (used regularly during the last 3 months before the planned knee surgery). Intraarticular corticoid medication is not allowed within the same time period.
3. Active infection or any other condition limiting the healing (e.g., immunodeficiency, hepatitis, active tuberculosis, neoplasm, diabetes and other serious metabolic disorders, drug abuse, etc.).
4. Concurrent or previous cancer.
5. Blood, plasma or platelet transfusion during previous 8 weeks.
6. Pregnant or lactating women.
7. BMI higher than 40.
8. Clinical instability of the knee joint.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Lysholm knee function score, at 24 months post-operation (comparison of score changes between the study arms).
2. KOOS value, at 24 months post-operation (comparison of score changes between the study arms).
3. Pain according to VAS, at 24 months post-operation (comparison of score changes between the study arms).
4. X-ray and MRI evaluation, at 24 months post-operation.

Secondary endpoints 5

1. Lysholm knee function score, at 3, 6 and 12 months post-operation.
2. KOOS value, at 3 , 6 and 12 months post-operation.
3. Pain according to VAS, at 6 weeks, 3, 6 and 12 months post-operation.
4. X-ray and MRI evaluation, at 12 months post-operation.
5. Adverse event profiles at 6 weeks, 3, 6, 12 and 24 months post-operation (comparison between the study arms).

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bioinova a.s.

Sponsor organisation

Bioinova a.s.

Address

Videnska 1083, Krc Krc

City

Prague 4

Postcode

142 00

Country

Czechia

Scientific contact point

Organisation

Bioinova a.s.

Contact name

Information service

Public contact point

Organisation

Bioinova a.s.

Contact name

Information service

Locations

1 EU/EEA country · 3 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

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