lumbar spondylosis (Lumbar disc disorder, Lumbar spondylosis)
Conditions
Interventions
Interventional administration of 10^7 or 10^8 of ADC spheroid using a 18 G-23G needle with fluoroscopy or echo guide
Sponsors
Hayashi Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) lumbar spondylosis patients (Lumbar disc disorder, Lumbar spondylosis) 2) Men and women whose consent acquisition date is more than 18 years and less than 100 years 3) Patients who can appropriately evaluate pain from start of screening to the end of observation for 48 weeks 4) Patients who have received sufficient explanation using ICF and understand the contents, and who have obtained written consent to participate in the study group based on their free will 5) Patients who can follow the scedule established until the end of the examination period
Exclusion criteria
Exclusion criteria: 1) Patients who have inflammatory diseases other than synovitis due to the primary disease at the target site on the screening test day or the first administration day, or patients with a history of these diseases within one year before obtaining consent 2) Patients who have low back pain surgery in the past 3) Patients who received physical therapy of the primary disease within 28 days before the screening start date 4)Patients with a history or complication of malignancy within 5 years before obtaining consent 5) Patients with the following symptoms or diseases that may affect the results -patients with severe heart disease, liver disease, kidney disease, blood disease or immunodeficiency -patients with systemic joint disease such as rheumatoid arthritics and gout -patients with peripheral neuropathy -patients with osteonecrosis of the disease site -patients with mental illness such as depression, dementia, schizophenia and anxiety -patients scheduled for surgery during the period from the date of consent to the end of observation for 12 months 6) Using anticoagulant or antiplatelet drug 7) Patients who have a history or complication of drug dependence or alcoholism 8) Presence of a metal implant or any other contraindication to magnetic resonance imaging (MRI). 9) Patients iudged inappropriate by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of spheroid of adipose-derived mesenchymal stem cells by cell number for lumber spondylosis adverse drug reaction and adverse event such as infection, bleeding, and anaphylaxis laboratory evidence | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of spheroid of adipose-derived mesenchymal stem cells by cell number for lumber spondylosis physiological function test imaging test (X-ray, MRI) Evaluation of lumber spondylosis pain, VAS (Visual Analogue Scale), ODI (Oswestyr Disability Index), SF-36 (Short form 36), JOABPEQ (JOA back pain evaluation questionnaire), etc | — |
Countries
Japan
Contacts
Public ContactIshihara Mamoru
Clinic Nagoya Chikusahills
Outcome results
None listed