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

Phase 1

• Conditions: Knee Cartilage Defect; MedDRA version: 20.1Level: PTClassification code 10007710Term: Cartilage injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0Level: PTClassification code 10052913Term: Cartilage operationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10057104Term: Cartilage repairSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.0Level: LLTClassification code 10072638Term: Articular cartilage defectSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-004067-31-CZ
• Lead Sponsor: Bioinova, s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-12
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1.Adult patients of either sex, age between 18 and 60 years.
2.Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage III, the cause of the defect being either trauma or progressive degeneration.
3.Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture followed by the application of the 3D scaffold chondrotissue®).
4.No previous knee surgery due to a chondral defect.
5.Preoperative level of haemoglobin at least 110 g per L.
6.Preoperative level of platelet count higher than 150 000 per mL.
7.Able to provide written informed consent.

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 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Ligament laxity or axial deformities over 10° on the study knee.
2.Systemic corticosteroid or immunosuppressive medication, or anticoagulant therapy, ongoing or recent, (used regularly during the last 3 months before the screening visit). Intraarticular corticosteroid 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, 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.Subject not using two reliable methods method of birth control.
8.BMI higher than 40.
9.Clinical instability of the joint objectified during the surgery.

Study & Design

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