Joint repair using an in vitro generated scaffold-free tissue engineerd construct (TEC) derived from autologous synovial mesenchymal stem cells
Phase 1
- Conditions
- Chondral lesions Meniscal lesions
- Registration Number
- JPRN-UMIN000001195
- Lead Sponsor
- Department of orthopaedics, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Patients with 1) Active local infection 2) Serious complications including malignancies 3) Alchol or drung abuse 4) Rheumatoid arthritis, gout, or pseudo gout 5) Abnormal alignment of lower extremity 6) Chondral lesion with more than 5cm2 7) Meniscal lesion with large defect more than one-third of whole meniscal body 8) Patello-femoral instability 9) Diabetes 10) Renal failure which requires dialysis 11) the medication which could affect chondral metabolosm such as vitamin C or hyaluronan 12) Infectious disease (HIV, HBV, HCV, HTLV, syphilis) 13) Pregnancy 14) Allergy 15) participation in other clinical trials 16)Judged inappropriate with other reason by the project investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events (National Cancer Institute-Common Toxicity; NCI-CTC; version 2, JACOG version) Arthoscopic assessment of repaired tissue using ICRS evaluation package (http://www.cartilage.org) for chondral lesions and Horibe score (J Bone Joint Surg Br. 1995; 77:245-9) for meniscal lesions.
- Secondary Outcome Measures
Name Time Method Periodical assessment of clinical symptoms, evaluation by MRI, histology, activity scales (Lyshlom, Tegnar), and by overall subjective assessment score (Knee Injury and Osteoarthritis Outcome Score; KOOS)