Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

Royan Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Liver Cirrhosis

Treatments: Biological: MNC; Biological: Control; Biological: CD133

Study type: Interventional

Funder types: Other

Identifiers

NCT01120925

Royan-Liver-002

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

MNC

Experimental group

Description:

Bone marrow derived MNC

Treatment:

Biological: MNC

CD133

Experimental group

Description:

CD133 derived from Bone marrow

Treatment:

Biological: CD133

Control

Placebo Comparator group

Description:

Normal saline with 5% Human Serum Albumin

Treatment:

Biological: Control