JPRN-jRCTb040200026
Recruiting
未知
Clinical trial on treatment of knee osteoarthritis using spheroid of adipose-derived mesenchymal stem cells
Shuji HAYASHI0 sites20 target enrollmentJuly 3, 2020
ConditionsKnee osteoarthritis
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Knee osteoarthritis
- Sponsor
- Shuji HAYASHI
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) KL Grade I or higher knee osteoarthritis patients
- •2\) Patient who have pain (VAS\>4\) at the target site more than 3 months before the date of consent
- •3\) Men and women whose consent acquisition date is more than 20 years and less than 80 years
- •4\) Patients who can appropriately evaluate pain from start of screening to the end of observation for 48 weeks
- •5\) 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
- •6\) Patients who can follow the scedule established until the end of the examination period
Exclusion Criteria
- •1\) Patients with pain other than the primary disease corresponding to any of the following within 7 days before the first administration day\-Pain other than the target site suring the screening period average 4 or more (Lumbar spinal canal stenosis, etc.)
- •2\) 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
- •3\) Patients who have undergone surgical procedures including arthroscopy for the disease site (exclucding drainage of joint fluid)
- •4\) Patients who received physical therapy of the primary disease within 28 days before the screening start date
- •5\)Patients with a history or complication of malignancy within 5 years before obtaining consent
- •6\) 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
Outcomes
Primary Outcomes
Not specified
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