Joint repair using an in vitro generated scaffold-free tissue engineerd construct (TEC) derived from autologous synovial mesenchymal stem cells

UMIN ID: UMIN000001195

Registered date:01/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chondral lesions Meniscal lesions
• Date of first enrollment: 2009/12/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Implantation of in vitro generated mesenchymal stem cell (MSC)-based tissue engineered construct (TEC) to chondral or meniscal lesions of the knee.

Outcome(s)

• Primary Outcome: 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: 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)

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of orthopaedics, Osaka University Graduate School of Medicine
• Secondary Sponsor: Osaka University Hospital, Medical center for translational Research
• Source(s) of Monetary Support: None