Clinical trial to compare the efficacy and safety of the treatment with the autologous chondrocyte transplantation product co.don chondrosphere® (ACT3D-CS) with microfracture in subjects with cartilage defects of the knee

Phase 1

• Conditions: Cartilage defects of knee joints, osteochondral defects; MedDRA version: 20.1Level: LLTClassification code 10007713Term: Cartilage tear in kneeSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0Level: LLTClassification code 10007702Term: Cartilage biopsySystem Organ Class: 100000004848; MedDRA version: 20.0Level: LLTClassification code 10003423Term: Articular cartilage disorderSystem Organ Class: 100000004859; MedDRA version: 20.0Level: PTClassification code 10052913Term: Cartilage operationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10007705Term: Cartilage damageSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0Level: HLTClassification code 10007709Term: Cartilage disordersSystem Organ Class: 100000004859; MedDRA version: 20.0Level: LLTClassification code 10057104Term: Cartilage repairSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.1Level: PTClassification code 10007710Term: Cartilage injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0Level: PTClassification code 10064112Term: Cartilage graftSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2009-016466-82-PL
• Lead Sponsor: CO.DON AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-14
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Male or female patients, age: between 18 and 50 years
2. Defect: isolated ICRS grade III or IV single defect chondral lesion on femoral condyle
3. Defect size: 1 to < 4 cm2 after debridement to healthy cartilage up to 6 mm in depth. Assessment with MRI at screening and per estimation during arthroscopy prior to randomization
4. Nearly intact chondral structure surrounding the defect as well as an intact corresponding joint area
5. Informed consent signed and dated by patient
6. Patient understands the strict rehabilitation protocol and follow-up programme and is willing to follow it
7. In case of pain, patient agrees to use only paracetamol mono- (max 4 g/day) or combination preparation and oral and/or topic NSAIDs during the trial and to discontinue the use of oral and/or topic NSAIDs and/or paracetamol combination preparation 1 week before each visit whereas the use of paracetamol mono-preparation (max 4 g/day) is allowed. However, in the morning of the visit day, no pain medication is allowed. Other pain medications are allowed during surgical procedure and may be taken for a period not exceeding 4 weeks after surgery.

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 102
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Defects on both knees at the same time
2. Radiological signs of osteoarthritis
3. Osteochondritis dissecans (OCD)
4. Any signs of knee instability
5. Valgus or varus malalignment (more than 5° over the mechanical axis)
6. Clinically relevant second cartilage lesion on the same knee
7. More than 50 % resection of a meniscus in the affected knee or incomplete meniscal rim
8. Rheumatoid arthritis, parainfectious or infectious arthritis, and condition after these diseases
9. Pregnancy and planned pregnancy (no MRI possible)
10. Obesity (Body Mass Index >30)
11. Uncontrolled diabetes mellitus
12. Serious illness
13. Poor general health as judged by physician
14. Participation in concurrent clinical trials or previous trials within 3 months of screening
15. Previous treatment with ACT in the affected knee
16. Microfracture performed less than 1 year before screening in the affected knee
17. Alcohol or drug (medication) abuse
18. Meniscal transplant in the affected knee
19. Meniscal suture (in the affected knee) three months prior to baseline
20. Mosaicplasty (Osteoarticular Transplant System, OATS) in the affected knee
21. Having received hyaluronic acid intra-articular injections in the affected knee within the last 3 months before baseline
22. Taking specific ostheoarthritis drugs such as chondroïtin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks before baseline
23. Corticosteroid treatment by intraarticular route within the last month of baseline or systemic (all routes) corticosteroids within the last 2 weeks before baseline
24. Chronic use of anticoagulants
25. Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee
26. Any clinically significant or symptomatic vascular or neurological disorder of the lower extremities
27. Any evidence of the following diseases in the affected knee: septic arthritis, inflammatory joint disease, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, haemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation
28. Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C virus (HCV) infection

Study & Design

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