Treatment of knee osteoarthritis using adipose tissue-derived stem cells

JRCT ID: jRCTb050220048

Registered date:13/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Knee osteoarthiritis
• Date of first enrollment: 13/06/2022
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intraarticular administration of A-ADSCs using a 21G needle with echo guide. Dosing at least 20 million cells in one ingection.

Outcome(s)

• Primary Outcome: Presence or absence of advese event

Secondary Outcome

Clinical score evalution such as WOMAC, JKOM, KOOS (4 weeks, 12 weeks, and 24 weeks after treatment)
MRI image evaluation (24 weeks after treatment)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Over 20 years old when obtaining consent
-No improvement in standard conservative therapy for insurance indication
-Don't request surgical treatment at the time of obtaining consent
-Obtain written consent sufficient explanation about this study
-Able to comply with a fixed schedule

Exclude criteria

-Patients who have difficulty with subcutaneous liposuction
-Patients with cancer
-Patients who are using anti-cancer drugs, biologics or immunosuppressants
-Patients with active infection
-Patients who have recieved this treatmentwithin a month
-Patients with serious complicaitons such asheart disease, liver diseaes, lung disease, kidny disease, bleeding tendency, uncontroled diabetes, hypertension, etc.
-Patients with a history of drug sensitivity to anesthetics
-Other patients judged inappropriate by doctors

Related Information

• Primary Sponsor: Satoshi Sobajima
• Source(s) of Monetary Support: Science and Technology Promotion Division