Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steminent Biotherapeutics Inc.

Criteria

Inclusion Criteria:

1. Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.

2. Subject's pain score is 8-13 points (Lequesne's index).

3. Ages between 50-70 years.

4. Signed informed consent from the subject.

5. Female subjects should be post-menopausal women

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 either side of 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.