meniscus lesions
Conditions
Interventions
Transplantation of autologous synovial stem cells on the meniscal lesions.
Sponsors
Tokyo Medical and Dental University, Medical Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are aged 20 years or older on the acquisition date of informed consent before clinical study, and who can give a written informed consent 2) Patients with meniscus injuries including radial, vertical flap, horizontal flap, horizontal, degenerative or complex tear and patients with meniscus injuries located in the avascular area 3) Patients with clinical symptoms of meniscus injury, including pain 4) Patients with one or more of the following symptoms in the knee: -catching sensation -instability feeling -limited range of motion -hydrarthrosis 5) Patients who are indicated for menisectomy of 100 mm2 or larger because of (2) to (4)
Exclusion criteria
Exclusion criteria: 1) Patient who is unidentified 2) Patients who underwent menisectomy or meniscus repair in the affected knee 3) Patients whose clinical symptoms have been sufficiently improved by conservative treatments in the last 3 months 4) Patients with knee malalignment. 5) Patients with a history of trauma in the knee 6) Patients for whom MRI is not indicated because of claustrophobia and so on 7) Patients who have had any intraarticular injections (local anesthetic agent, corticosteroid agent, hyaluronic acid) or arthrocentesis in these 3 months. 8) Patients with active infection 9) Patients diagnosed or suspected as malignant tumor in these 5 years 10) Patients sensitive to antibiotics (penicillin, streptomycin or amphotericin B) 11) Patients sensitive to animal (bovine) origin materials 12) Patients with poor controlled diabetes 13) Patients with a pacemaker 14) Patients with poor general condition with following complication; -severe cardiovascular disease -severe liver disorder -severe kidney dysfunction -poorly controlled psychiatric disorder -other diseases which sudden deterioration or aggravation is foreseeable during the study period 15) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study 16) Patient who participated in other clinical trials, patient participating in other clinical studies and patient planning to participate in other clinical studies while participating in this clinical study within 12 weeks before the start of transplantation of cellular product 17) Patient for whom doctors decide as not appropriate to participate in the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lysholm score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Efficacy Knee Injury and Osteoarthritis Outcome Score (KOOS) Numerical Rating Scale (NRS) Knee X-ray examination, MRI 3D analysis (meniscal thickness, height, width) MRI analysis of meniscal / cartilage degeneration 2) Safety Adverse event and device-related adverse event data, including type, frequency, severity and duration | — |
Countries
Japan
Contacts
Public ContactOffice Administrator
Tokyo Medical and Dental University, Medical Hospital Clinical Research Center
Outcome results
None listed