Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120925
• Other study ID #: Royan-Liver-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 8, 2010
• Last updated: April 24, 2014
• Start date: May 2010
• Est. completion date: July 2013

Study information

• Verified date: May 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Biological:
• MNC
2-3 X 109 cells in 20ML suspension IPV in 4 min
• CD133
5-15 X 106 cells in 20ML suspension IPV
• Control
Injection of 20 ml Normal saline via IPV

Locations

Country	Name	City	State
Iran, Islamic Republic of	Gastroenterology and hepatic disease research center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Royan Institute	University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver function test	Meld score, Child score	6 months	Yes
Secondary	Cirrhosis Mortality		6 months	Yes

External Links

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