A comparison of two different cell types for treating osteoarthritis in the knee.
- Conditions
- osteochondral defects of the knee (early osteoarthritis)MedDRA version: 14.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2010-022072-31-GB
- Lead Sponsor
- RJAH Orthopaedic Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 114
1. A symptomatic chondral defect of the knee that extends to (Outerbridge grade 4) or into the subchondral bone.
2. The defect is considered suitable for treating with autologous cell therapy.
3. Previous surgical treatment of the defect has failed to relieve symptoms.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1. Positive for HIV, hepatitis B or C, syphilis, or human T cell lymphotrophic virus (HTLV) I or II.
2. Likely to show contraindications to autologous cell therapy: patients with inflammatory condition, history of mesenchymal tumours, therapy with steroids or methotrexate, bleeding tendency or known anaphylaxis to any product used in cell preparation.
3. Low probability of compliance with physiotherapy or follow-up, including a major life-threatening condition.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method