Study of the safety concernig autolougaus adipose tissue-derived stem cells for osteoarthritis of knee joint.
- Conditions
- Knee osteoarthritis
- Registration Number
- JPRN-jRCTb040190123
- Lead Sponsor
- Tsutsumi Mikihiro
- Brief Summary
In this study, knee osteoarhritis was treated with autologous Lipogems products. There were 5 females aged 56 to 63 years old (mean 60 years old), who were 2 as grade II, 2 as grade II and one as grade IV of (K-L). Clinical evaluation was performed at 1 week, 1, 3 and 6 months after the operation, and no adverse event was observed. Both VAS and KOOS were significantiy increased after surgery, suggesting that treatment with Lipogems products for patients with knee osteoarthraitis may be safe and useful.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 5
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events
- Secondary Outcome Measures
Name Time Method improvement effect