Healing acceleration of repaired meniscus by synovial stem cells "Clinical study to assess the safety and efficacy of transplantation of autologous synovial mesenchymal stem cells in patients with knee meniscal tear"
Not Applicable
- Conditions
- Knee meniscal tear
- Registration Number
- JPRN-UMIN000011881
- Lead Sponsor
- Tokyo Medical and Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who didn't give a written informed consent 2) Patients with active infection 3) Patients positive for HIV (HIV-1, HIV-2), HBV, HCV, or HTLV-1 4) Patients with active malignant tumors 5) Patients with sensitivity to antibiotic 6) Pregnant or breast-feeding women 7) Patients with diabetes 8) Patients in bad general condition 9) Patients evaluated as a contraindication to the clinical study by one's doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of clinical research is evaluated on the presence, severity and frequency of adverse events caused by autologous synovial stem cells.
- Secondary Outcome Measures
Name Time Method 1) Feasibility of the quality control of cultured synovial stem cells 2) Subjective symptom (KOOS and NRS scores based on patient-oriented evaluation) and knee symptom before and after 4, 6, 12, 24 weeks of meniscal repair. 3) MRI assessment of sutured meniscus before and after 12, 24 weeks of meniscal repair 4) Width of joint space evaluated by X-ray examination before and after 12, 24 weeks of meniscal repair