Clinical trial NCT04212728: Treatment of Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells
Official title: Treatment of Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Yantai Yuhuangding Hospital
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subject has Kellgren and Lawrence grade II-IV primary osteoarthritis as determined by X-ray.
2. Subject's pain score is 8-13 points (Lequesne's index).
3. Ages between 40-70 years.
4. Signed informed consent from the subject.

Exclusion Criteria:

1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV
2. Subject not suitable for liposuction surgery.
3. Subject with hypersensitivity/allergy to anesthetic.
4. Subject's creatinine values higher than 1.6mg/dl.
5. Subject with body mass index, BMI over 30.
6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
7. Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
8. Subject enrolled in any other cell therapy studies within the past 30 days.
9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.

Primary outcomes:
measure: Physical function change
timeFrame: From before randomization until 3, 6, and 12 months after treatment start.
measure: Change in pain density
timeFrame: From before randomization until 3, 6, and 12 months after treatment start.
Secondary outcomes:
measure: Cartilage repair
timeFrame: From before randomization until 3, 6, and 12 months after treatment start.
measure: Change in MOS item short from health survey(SF-36)
timeFrame: From before randomization until 3, 6, and 12 months after treatment start.
measure: Change in Lequesne Index
timeFrame: From before randomization until 3, 6, and 12 months after treatment start.
measure: Change in knee society score (KSS)
timeFrame: From before randomization until 3, 6, and 12 months after treatment start.
Other outcomes:
Locations:
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
Study officials:
affiliation: Yantai Yuhuangding Hospital
name: Peiwen Lian, PhD
role: STUDY_DIRECTOR
References: