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

Yantai Yuhuangding Hospital

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Biological: Auotologous PRP; Biological: Auotologous AMSCs plus autologous PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT04212728

2019-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

AMSCs plus PRP group

Experimental group

Description:

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.

Treatment:

Biological: Auotologous AMSCs plus autologous PRP

PRP group

Active Comparator group

Description:

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.

Treatment:

Biological: Auotologous PRP