Treatment of Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Yantai Yuhuangding Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Physical function change
Study Overview
Brief Summary
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.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
AMSCs plus PRP group
Three intra-articular injections in total and autologous adipose-derived mesenchymal stem cells (AMSCs) suspended in 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.
Intervention: Auotologous AMSCs plus autologous PRP (Biological)
PRP group
Three intra-articular injections in total and 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.
Intervention: Auotologous PRP (Biological)
Outcomes
Primary Outcomes
Physical function change
Time Frame: 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
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.
Secondary Outcomes
- Cartilage repair(From before randomization until 3, 6, and 12 months after treatment start.)
- Change in MOS item short from health survey(SF-36)(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.)
Investigators
Peiwen Lian
Peiwen Lian Ph.D
Yantai Yuhuangding Hospital