Autologous Mesenchymal Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Yantai Yuhuangding Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Change in pain density
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to explore the efficacy and safety of autologous bone marrow-derived mesenchymal stem cells (BMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.
Detailed 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 BMSCs 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 BM-MSCs in patients with severe knee osteoarthritis.
Investigators
Peiwen Lian
Principle Investigator
Yantai Yuhuangding Hospital
Eligibility Criteria
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 bone marrow suction surgery.
- •Subject with hypersensitivity/allergy to anesthetic.
- •Subject's creatinine values higher than 1.6mg/dl.
- •Subject with body mass index, BMI over
- •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.
Outcomes
Primary Outcomes
Change in pain density
Time Frame: 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.
Physical function change
Time Frame: From before randomization until 3, 6, and 12 months after treatment start.
Evaluation the physical function change Measured by WOMAC osteoarthritis index.
Secondary Outcomes
- Change in MOS item short from health survey(SF-36)(From before randomization until 3, 6, and 12 months after treatment start.)
- Cartilage repair(From before randomization until 3, 6, and 12 months after treatment start.)
- Change in Lequesne Index(From before randomization until 3, 6, and 12 months after treatment start.)
- Change in knee society score (KSS)(From before randomization until 3, 6, and 12 months after treatment start.)