Status:
UNKNOWN
Efficacy of Bone-marrow-derived and Placenta-derived Multipotent Mesenchymal Stem / Stromal Cells for Osteoarthritis
Lead Sponsor:
Institute of Cell Therapy
Collaborating Sponsors:
The Institute of Traumatology and Orthopedics of NAMS of Ukraine
Kyiv City Clinical Hospital № 6
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed 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 pro...
Eligibility Criteria
Inclusion
- Clinical diagnosis of knee osteoarthritis.
- Age: 18 to 75 years old.
- Kellgren-Lawrence Grade 2 or 3 according to X-ray imaging.
- Knee pain.
- Written informed consent
Exclusion
- Age \<18 or \>75 years of age by time of infusion.
- Participation in an on-going investigational therapeutic or device trial 30 days of consent.
- Rheumatoid arthritis.
- Psoriatic arthritis.
- Juvenile idiopathic arthritis.
- Gout.
- Infectious arthritis.
- Osteomyelitis.
- Osteonecrosis.
- Inflammatory arthritis.
- Chondropathy.
- Joint contracture.
- Arthroplasty.
- Arthroscopy within 6 months prior to study entry.
- Intra-articular injection within 3 months prior to study entry.
- Hormone intake.
- Antiaggregants and anticoagulants intake.
- Immunosuppressants intake.
- Allergy to hyaluronic acid.
- History of organ or cell transplantation.
- Hematologic abnormality evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet count \< 100,000/ul.
- Active infection.
- Positive for HIV antigen.
- History of hepatitis B, hepatitis C.
- History of malignancy in the last 5 years prior to study entry.
- Active tumors.
- History of myocardial infarction.
- History of stroke.
- Renal failure with chronic hemodialysis.
- Liver Cirrhosis (ICGR 15 \>30%).
- Chromosomal abnormality.
- Peripheral nervous system disorders.
- Cognitive or language barriers that prohibit obtaining informed consent or any study elements.
- 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.
- Pregnant/nursing women or women of child-bearing potential.
- Other condition that limits lifespan to \< 1 year.
Key Trial Info
Start Date :
January 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04453111
Start Date
January 2 2020
End Date
October 1 2021
Last Update
July 7 2020
Active Locations (1)
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1
Institute of Cell Therapy
Kyiv, Ukraine, 04073