Efficacy of Bone-marrow-derived and Placenta-derived Multipotent Mesenchymal Stem / Stromal Cells for Osteoarthritis

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To define the clinical effects of intra-articular transplantation of bone-marrow-derived (BM-MMSCs) and placenta-derived multipotent mesenchymal stem / stromal cells (P-MMSCs) for knee osteoarthritis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cell Therapy
• Collaborators: Kyiv City Clinical Hospital № 6; The Institute of Traumatology and Orthopedics of NAMS of Ukraine
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

1. Clinical diagnosis of knee osteoarthritis.

2. Age: 18 to 75 years old.

3. Kellgren-Lawrence Grade 2 or 3 according to X-ray imaging.

4. Knee pain.

5. Written informed consent

Exclusion Criteria:

1. Age <18 or >75 years of age by time of infusion.

2. Participation in an on-going investigational therapeutic or device trial 30 days of consent.

3. Rheumatoid arthritis.

4. Psoriatic arthritis.

5. Juvenile idiopathic arthritis.

6. Gout.

7. Infectious arthritis.

8. Osteomyelitis.

9. Osteonecrosis.

10. Inflammatory arthritis.

11. Chondropathy.

12. Joint contracture.

13. Arthroplasty.

14. Arthroscopy within 6 months prior to study entry.

15. Intra-articular injection within 3 months prior to study entry.

16. Hormone intake.

17. Antiaggregants and anticoagulants intake.

18. Immunosuppressants intake.

19. Allergy to hyaluronic acid.

20. History of organ or cell transplantation.

21. Hematologic abnormality evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet count < 100,000/ul.

22. Active infection.

23. Positive for HIV antigen.

24. History of hepatitis B, hepatitis C.

25. History of malignancy in the last 5 years prior to study entry.

26. Active tumors.

27. History of myocardial infarction.

28. History of stroke.

29. Renal failure with chronic hemodialysis.

30. Liver Cirrhosis (ICGR 15 >30%).

31. Chromosomal abnormality.

32. Peripheral nervous system disorders.

33. Cognitive or language barriers that prohibit obtaining informed consent or any study elements.

34. History of drug abuse or alcohol abuse, or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months.

35. Pregnant/nursing women or women of child-bearing potential.

36. Other condition that limits lifespan to < 1 year.