Clinical trial on treatment of osteoarthritis using chondrocyte spheroids differentiated from adipose-derived mesenchymal stem cells - Clinical trial on osteoarthritis using chondrocyte spheroids differentiated from adipose-derived mesenchymal stem cells

Hayashi Shuji0 sites20 target enrollmentAugust 19, 2022

Overview

No summary available.

Registry

who.int

Start Date

August 19, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Hayashi Shuji

•1\) KL Grade I or higher 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

•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