Study of the safety concernig autolougaus adipose tissue-derived stem cells for osteoarthritis of knee joint.

JRCT ID: jRCTb040190123

Registered date:03/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Knee osteoarthritis
• Date of first enrollment: 18/06/2019
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Administer Lipogems products into knee joint space of degenerative osteoarthritis under general anesthesia.

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: improvement effect

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) 30 to 85 years of age
2) grade II-IV (Kellgren-Lawrence) by X-ray
3) persistent symptoms for more than 6 months
4) failure of conservative management
5) possibility general anesthesia

Exclude criteria

1)History of active neoplasm and active inflammatory disease
2) severe symptom by cerebral infarction and pulmonary infarction
3) rheumatoid arthritis and gout
4) pregnancy or lactation
5) thrombocytopenia
6) participation in other clinical studies
7) positive test result against HIV, HBV, HCV, syphilis or HTLV-1
8) severe DM, heart failure or renal failure.

Related Information

• Primary Sponsor: Tsutsumi Mikihiro