Treatment of Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells

NCT04212728 NA UNKNOWN

The purpose of this study is to explore the efficacy and safety of autologous adipose-derived mesenchymal stem cells (AMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.

Details

Lead sponsor	Yantai Yuhuangding Hospital
Phase	NA
Status	UNKNOWN
Enrolment	60
Start date	2019-12-29
Completion	2024-12

Conditions

• Knee Osteoarthritis

Interventions

• Auotologous AMSCs plus autologous PRP
• Auotologous PRP

Primary outcomes

• Physical function change — From before randomization until 3, 6, and 12 months after treatment start.
  Evaluation the physical function change measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
• Change in pain density — From before randomization until 3, 6, and 12 months after treatment start.
  Evaluation the changing of pain density measured by Visual Analogue Scale. Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.

Countries

China