Autologous Stem cells, Chondrocytes Or the Two?
- Conditions
- Symptomatic cartilage defects in the kneeMusculoskeletal DiseasesArthritis
- Registration Number
- ISRCTN98997175
- Lead Sponsor
- Robert Jones and Agnes Hunt Orthopaedic Hospital (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 114
1. A symptomatic defect of the knee that extends to (Outerbridge grade 4) or into the subchondral bone
2. The patient will be aged between 18 and 80 years at the time of surgery
3. The defect is considered suitable for ACI
4. Surgical treatment has been performed on the same defect at least 6 months previously and has failed to relieve symptoms
5. The patient is able to provide written informed consent to participate in the trial
1. English is not the first language of the patient
2. Likely to show contraindications to autologous cell therapy:
2.1. Osteoarthritis
2.2. Inflammatory arthritis
2.3. Previous or current malignant tumour
2.4. Therapy with steroids or methotrexate
2.5. Bleeding tendency or known anaphylaxis to any product used in chondrocyte preparation
3. Low probability of compliance with physiotherapy or follow-up, including a major life threatening condition
4. A defect of greater than 20cm2 in total area
5. The patient is shown to be positive for serology tests required by the cell provider. This includes:
5.1. HIV
5.2. Hepatitis B and C
5.3. Syphilis
5.4. Human T cell lymphotrophic virus (HTLV) I & II
6. Pregnancy or lactation
7. Exclusion criteria (5) and (6) will not be confirmed until after written informed consent is obtained
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-reported functional knee score (Modified Lysholm) at 15 months, taking into account the pre-operative score as a covariate
- Secondary Outcome Measures
Name Time Method