Efficacy of Bone-marrow-derived and Placenta-derived Multipotent Mesenchymal Stem / Stromal Cells for Osteoarthritis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee osteoarthritis.
- •Age: 18 to 75 years old.
- •Kellgren-Lawrence Grade 2 or 3 according to X-ray imaging.
- •Written informed consent
排除标准
- •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.
- •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.
研究组 & 干预措施
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
干预措施: Placenta-derived MMSCs (Biological)
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
干预措施: Hyalgan 20 mg in 2 ML Prefilled Syringe (Drug)
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
干预措施: Bone marrow-derived MMSCs (Biological)
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
干预措施: Hyalgan 20 mg in 2 ML Prefilled Syringe (Drug)
Hyaluronic Acid (HA)
Three intra-articular injection of 20 mg Hyaluronic Acid - 15 patients
干预措施: Hyalgan 20 mg in 2 ML Prefilled Syringe (Drug)
结局指标
主要结局
Number of participants with adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.
时间窗: 12 months
Treatment-related adverse events
次要结局
- Quality of Life (QOL) assessment(12 months)
- Radiographic evidence. Whole-Organ Magnetic Resonance Imaging Score (WORMS)(12 months)
- The Visual Analog Scale (VAS) assessment(12 months)
- Physical function improvement measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).(12 months.)