Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01120925

Enrollment

Registered

2010-05-11

Start date

2010-05-31

Completion date

2013-07-31

Last updated

2014-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

Cirrhotic, Stem Cells, Bone marrow stem cells, Decompensate Cirrhotic Patients

Brief summary

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.

Detailed 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

Interventions

BIOLOGICALMNC

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

BIOLOGICALCD133

5-15 X 106 cells in 20ML suspension IPV

BIOLOGICALControl

Injection of 20 ml Normal saline via IPV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Liver function test	6 months	Meld score, Child score

Secondary

Measure	Time frame
Cirrhosis Mortality	6 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026