Phase I/II Study of Transplantation of Autologous Adipose Stem Cells and Activated Platelet Rich Plasma in Knee Osteoarthritis Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.
详细描述
The proposed study is two centers, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) in combination with platelet rich plasma (PRP).
This study aimes to evaluate the clinical efficiency of autologous adipose tissue-derived MSC transplantation in patients with confirmed osteoarthritis at grade II and III. Adipose tissue is isolated from the belly, and used for extraction of the SVF. The SVF is mixed with activated platelet-rich plasma before injection. The clinical efficiencies are evaluated by the pain score (VAS), Lysholm score, and MRI findings. SVF is isolated from about 100 mL of adipose tissue, and PRP is prepared from 20 mL of peripheral blood. Total injection volume will be about 5-10 mL. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years and ability to understand the planned treatment.
- •Idiopathic or secondary osteoarthritis of the knee with grade 2, 3 radiographic severity
- •Ability and willingness to undergo liposuction
排除标准
- •Pregnant women or cognitively impaired adults.
- •Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
- •Inflammatory or postinfectious arthritis.
- •More than 5 degrees of varus or valgus deformity.
- •Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
- •Intraarticular corticosteroid injection within the previous 3 months.
- •A major neurologic deficit.
- •Serious medical illness with a life expectancy of less than 1 year.
- •Prior admission for substance abuse
- •Body Mass Index (BMI) of 40 kg/m2 or greater
- •Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
- •In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
结局指标
主要结局
Number of participants with adverse events
时间窗: 6 months
次要结局
- Change from the baseline pain score (VAS) at 6 months(6 months, 12 months, 18 months)
- Change from baseline MRI assessment(12 months)
- Change from baseline Lysholm score at 6 months(6 months, 12 months, 18 months)
研究者
Phuc Van Pham
Laboratory of Stem Cell Research and Apllication
University of Science Ho Chi Minh City