Comparison of Therapeutic Outcome of Twice Transplantation of CD133+ and MNC BM Derived Stem Cells in Cirrhotic Patients: Clinical Trial, Double Blind, Phase I/II
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Liver function test
研究概览
简要总结
Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it's crucial problems. The plasticity of stem cells in bone marrow (BM) to differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study, the investigators will study safety and feasibility of twice transplantation of Autologous bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through the portal vein in patients with decompensate cirrhosis.
详细描述
BM Aspiration will be done twice (3months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16-65 Years cirrhotic patient
- •Approved cirrhosis by elastografy ,biopsy, sonography
- •Serum ALT 1/5 times more than normal
- •MELD score 12 or Child score B or C
排除标准
- •Portal vein thrombosis
- •Hepatic encephalopathy, score 3&4
- •ALT & AST 3times more than normal
- •Serum Cr more than 1/5mg/dL
- •(Anti-HIV +) (Anti-HCV+) (HBS-Ag+)
- •Hepatocel carcinoma
- •Primary sclerosing cholangitis (PSC)
- •Esophageal varices grade 4
- •Addiction
结局指标
主要结局
Liver function test
时间窗: 6 months
Meld score, Child score
次要结局
- Cirrhosis Mortality(6 months)