Overview
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.
Description
This is a single centered, randomized, single blind phase II clinical study. Patients will be divided into two groups of case and control. Patients of case group will receive intra-articular injection of autologous AMSCs suspended in 3 ml autologous PRP for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous PRP for 3 times. The investigators designed this clinical study to evaluate therapeutic effects of AMSCs in patients with severe knee osteoarthritis.
Eligibility
Inclusion Criteria:
- Subject has Kellgren and Lawrence grade II-IV primary osteoarthritis as determined by X-ray.
- Subject's pain score is 8-13 points (Lequesne's index).
- Ages between 40-70 years.
- Signed informed consent from the subject.
Exclusion Criteria:
- Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV
- Subject not suitable for liposuction surgery.
- Subject with hypersensitivity/allergy to anesthetic.
- Subject's creatinine values higher than 1.6mg/dl.
- Subject with body mass index, BMI over 30.
- Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
- Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
- Subject enrolled in any other cell therapy studies within the past 30 days.
- Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
- Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
- Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.