Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

NCT01120925 | Completed Phase 1 DMC

• 1 other identifier: Royan-Liver-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Liver function test

  Meld score, Child score

  6 months

Secondary Outcomes (1)

• Cirrhosis Mortality

  6 months

Study Arms (3)

MNC

EXPERIMENTAL

Bone marrow derived MNC

Biological: MNC

CD133

EXPERIMENTAL

CD133 derived from Bone marrow

Biological: CD133

Control

PLACEBO COMPARATOR

Normal saline with 5% Human Serum Albumin

Biological: Control

Interventions

MNC BIOLOGICAL

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

MNC

CD133 BIOLOGICAL

5-15 X 106 cells in 20ML suspension IPV

CD133

Control BIOLOGICAL

Injection of 20 ml Normal saline via IPV

Control

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royan Institute: lead
• University of Tehran: collaborator

Study Sites (1)

Gastroenterology and hepatic disease research center

Tehran, Tehran Province, 14114, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hamid Gourabi, PhD

  Royan Institute

  STUDY CHAIR

• Reza Malekzadeh, MD

  Gastroenterology and hepatic disease research center

  STUDY CHAIR

• Hossein Baharvand, PhD

  Royan Institute

  PRINCIPAL INVESTIGATOR

• Mohammad Bagheri, MD

  Gastroenterology and hepatic disease research center

  PRINCIPAL INVESTIGATOR

• Massoud Vosough, MD

  Royan Institute

  STUDY DIRECTOR

• Nasser Aghdami, MD., PhD

  Royan Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2010
• First Posted: May 11, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 28, 2014

Record last verified: 2010-05

Locations

IR (1)