Clinical trial NCT01120925: Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Keywords: Cirrhotic
Stem Cells
Bone marrow stem cells
Decompensate Cirrhotic Patients
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
Collaborators: name: University of Tehran
First posted: 2010-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Liver function test
timeFrame: 6 months
Secondary outcomes:
measure: Cirrhosis Mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Gastroenterology and hepatic disease research center
Study officials:
affiliation: Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Gastroenterology and hepatic disease research center
name: Reza Malekzadeh, MD
role: STUDY_CHAIR
affiliation: Royan Institute
name: Hossein Baharvand, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenterology and hepatic disease research center
name: Mohammad Bagheri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royan Institute
name: Massoud Vosough, MD
role: STUDY_DIRECTOR
affiliation: Royan Institute
name: Nasser Aghdami, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: