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

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

N/A

Clinical Study ID

NCT04212728

2019-003

Ages 40-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 monthsprior to screen.
Subject has undergone surgery on studied knee, including fracture surgery,arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstructionsurgery.
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 anyother reasons than those listed above.
Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis andany other autoimmune arthritis of the knee joint.
Subject has had major medical problems in vital organs, such as; heart, liver, kidney,or lung.

Study Design

December 29, 2019

December 31, 2024

Study 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.

Connect with a study center

Yantai Yuhuangding Hospital
Yantai, Shandong 264000
China
Active - Recruiting

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