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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04453111
• Other study ID #: #7/09.26.2018
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2, 2020
• Est. completion date: October 2021

Study information

• Verified date: July 2020
• Source: Institute of Cell Therapy
• Contact: Peter Nemtinov, MD
• Phone: +380442079207
• Email: nemtinov[@]stemcellclinic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Multipotent mesenchymal stem / stromal cells (MMSCs) of different origin are the novel therapeutic agents that can slow down cartilage degeneration, improve reparation and ultimately prevent joint prosthetics. MSCs are capable to direct differentiation into chondrocytes, produce cytokines and growth factors with immunomodulatory and anti-inflammatory effects, stimulate angiogenesis, as well as induce chemotaxis of endogenous progenitors. Bone marrow-derived and placenta-derived MMSCs can be considered the most promising source for cell therapy of joints disorders according to availability, safety and expected therapeutic efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Placenta-derived MMSCs
Cryopreserved placenta-derived multipotent mesenchymal stem / stromal cells
• Bone marrow-derived MMSCs
Cryopreserved bone marrow-derived multipotent mesenchymal stem / stromal cells

Drug:
• Hyalgan 20 mg in 2 ML Prefilled Syringe
Hyaluronic Acid 20 mg

Locations

Country	Name	City	State
Ukraine	Institute of Cell Therapy	Kyiv

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Cell Therapy	Kyiv City Clinical Hospital ? 6, The Institute of Traumatology and Orthopedics of NAMS of Ukraine

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.	Treatment-related adverse events	12 months
Secondary	Physical function improvement measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).	Change in joint function from baseline WOMAC assessment. The WOMAC used a scoring scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). The higher the score, the higher the amount of pain, stiffness, and a high level of functional limitations.	12 months.
Secondary	Radiographic evidence. Whole-Organ Magnetic Resonance Imaging Score (WORMS)	Change in cartilage thickness of the knee using MRI	12 months
Secondary	Quality of Life (QOL) assessment	Change in scores on the QOL	12 months
Secondary	The Visual Analog Scale (VAS) assessment	VAS - measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "worst imaginable pain" (score of 10).	12 months