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Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

Primary Purpose

Liver Cirrhosis

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

MNC

CD133

Control

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Cirrhotic, Stem Cells, Bone marrow stem cells, Decompensate Cirrhotic Patients

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Gastroenterology and hepatic disease research center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

MNC

CD133

Control

Arm Description

Bone marrow derived MNC

CD133 derived from Bone marrow

Normal saline with 5% Human Serum Albumin

Outcomes

Primary Outcome Measures

Liver function test

Meld score, Child score

Secondary Outcome Measures

Cirrhosis Mortality

Full Information

NCT ID

NCT01120925

First Posted

May 8, 2010

Last Updated

April 24, 2014

Sponsor

Royan Institute

Collaborators

University of Tehran

1. Study Identification

Unique Protocol Identification Number

NCT01120925

Brief Title

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

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

Collaborators

University of Tehran

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cirrhosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MNC

Arm Type

Experimental

Arm Description

Bone marrow derived MNC

Arm Title

CD133

Arm Type

Experimental

Arm Description

CD133 derived from Bone marrow

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Normal saline with 5% Human Serum Albumin

Intervention Type

Biological

Intervention Name(s)

MNC

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

CD133

Intervention Description

5-15 X 106 cells in 20ML suspension IPV

Intervention Type

Biological

Intervention Name(s)

Control

Intervention Description

Injection of 20 ml Normal saline via IPV

Primary Outcome Measure Information:

Title

Liver function test

Description

Meld score, Child score

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Cirrhosis Mortality

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials: