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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2021-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Experimental: HA + stem cells therapy Experimental Group 1: three intra-articular injection of allogeneic P-MMSCs with up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients Experimental Group 2: three intra-articular injection of autologous BM-MMSCs up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients Control Group: three intra-articular injection of 20 mg Hyaluronic Acid, no cell therapy - 15 patients

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyaluronic Acid (HA) + P-MMSCs

Experimental Group 1: Three intra-articular injection of allogeneic P-MMSCs up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients

Group Type EXPERIMENTAL

Placenta-derived MMSCs

Intervention Type BIOLOGICAL

Cryopreserved placenta-derived multipotent mesenchymal stem / stromal cells

Hyalgan 20 mg in 2 ML Prefilled Syringe

Intervention Type DRUG

Hyaluronic Acid 20 mg

Hyaluronic Acid (HA) + BM-MMSCs

Experimental Group 2: Three intra-articular injection of autologous BM-MMSCs up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients

Group Type EXPERIMENTAL

Bone marrow-derived MMSCs

Intervention Type BIOLOGICAL

Cryopreserved bone marrow-derived multipotent mesenchymal stem / stromal cells

Hyalgan 20 mg in 2 ML Prefilled Syringe

Intervention Type DRUG

Hyaluronic Acid 20 mg

Hyaluronic Acid (HA)

Three intra-articular injection of 20 mg Hyaluronic Acid - 15 patients

Group Type ACTIVE_COMPARATOR

Hyalgan 20 mg in 2 ML Prefilled Syringe

Intervention Type DRUG

Hyaluronic Acid 20 mg

Interventions

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Placenta-derived MMSCs

Cryopreserved placenta-derived multipotent mesenchymal stem / stromal cells

Intervention Type BIOLOGICAL

Bone marrow-derived MMSCs

Cryopreserved bone marrow-derived multipotent mesenchymal stem / stromal cells

Intervention Type BIOLOGICAL

Hyalgan 20 mg in 2 ML Prefilled Syringe

Hyaluronic Acid 20 mg

Intervention Type DRUG

Other Intervention Names

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P-MMSCs BM-MMSCs HA

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No