Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MNC

Bone marrow derived MNC

Group Type EXPERIMENTAL

MNC

Intervention Type BIOLOGICAL

2-3 X 109 cells in 20ML suspension IPV in 4 min

CD133

CD133 derived from Bone marrow

Group Type EXPERIMENTAL

CD133

Intervention Type BIOLOGICAL

5-15 X 106 cells in 20ML suspension IPV

Control

Normal saline with 5% Human Serum Albumin

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BIOLOGICAL

Injection of 20 ml Normal saline via IPV

Interventions

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MNC

2-3 X 109 cells in 20ML suspension IPV in 4 min

Intervention Type BIOLOGICAL

CD133

5-15 X 106 cells in 20ML suspension IPV

Intervention Type BIOLOGICAL

Control

Injection of 20 ml Normal saline via IPV

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No