Protocol summary

Summary
Objectives: To evaluate the effect of bone marrow stem cell injection in the peripheral vein on the treatment of decompensated cirrhotic patients. Design: Interventional, randomized, non-blinded design Target sample size: Twenty patients suffering from liver cirrhosis, waiting for liver ransplant. Major inclusion criteria: Age range of 18 to 60 years; Having cirrhosis, based on clinical symptoms and laboratory, endoscopic and radiological findings; Being a candidate for liver transplant. Major exclusion criteria: Concurrent diseases such as heart, kidney, and pulmonary conditions; Presence of a hepatic mass indicating hepatocellular carcinoma, according to radiological findings. Intervention: Stem cells (120-200 CC) are injected in patients with liver cirrhosis, using special filters to collect fat particles, possible clots and other particles during one hour. Setting and conduct: Bone marrow aspiration is generally performed to obtain bone marrow cells. After collecting 120 cc of bone marrow cells, the number and percentage of nucleated cells are determined by a laboratory expert. Aspiration continues until the total number of nucleated cells reaches the minimum acceptable threshold of about 10 (9)*1. Then, the total volume of aspirated bone marrow cells is injected in patients with liver cirrhosis, using special filters to collect fat particles, possible clots, and other particles over one hour. Main outcome measures: Laboratory tests (albumin, hemoglobin and blood clotting tests) were carried out once a week after the intervention for a period of two week by blood test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014091919217N1
Registration date: 2014-10-23, 1393/08/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-10-23, 1393/08/01
Registrant information
Name
Homeira Ommati
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 2388
Email address
omatih9111@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-06-01, 1394/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of autologous bone marrow stem cells transfusion in treatment of cirrhotic, in decompensated cirrhotic patients
Public title
Treatment of cirrhotic of liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age range of 18 to 60 years; Having cirrhosis, based on clinical symptoms and laboratory, endoscopic and radiological findings; Being a candidate for liver transplant. Exclusion criteria: Concurrent diseases such as heart, kidney, and pulmonary conditions; Presence of a hepatic mass indicating hepatocellular carcinoma, according to radiological findings; Extrahepatic malignancies; Moderate to severe hepatic encephalopathy; HIV positive; Presence of malignancies; Activated hepatic vein thrombosis, spleen and portal venous; Concurrent extrahepatic infections; Active venous bleeding; History of alcohol consumption; Lack of patient’s consent
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
20 People, via lottery, were selected between patients who were candidate to waiting for Liver Transplant

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad, Iran
City
Mashhad
Postal code
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
920377

Health conditions studied

1

Description of health condition studied
Cirrhotic of liver
ICD-10 code
K76.1
ICD-10 code description
Chronic passive congestion of liver

Primary outcomes

1

Description
MELD score
Timepoint
Every week after the intervention for two weeks
Method of measurement
Calculating by algorithm formula.

2

Description
Laboratory tests (albumin, hemoglobin and blood clotting tests)
Timepoint
once a week after the intervention for a period of two week
Method of measurement
Blood test

3

Description
Child score
Timepoint
Every week after the intervention for two weeks
Method of measurement
Calculating by algorithm formula.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Stem cells (120-200 CC) are injected in patients with liver cirrhosis, using special filters to collect fat particles, possible clots and other particles during one hour.
Category
Treatment - Other

2

Description
Control group: Patients with liver cirrhosis, not receiving stem cells, were allocated to the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Homeira Omati
Street address
Imam Reza hospital, Imam Reza square, Mashhad, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Saeed Eslami
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Homeira Omati
Position
Resident
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3846 2388
Fax
Email
internist_omati@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Homeira Omati
Position
Resident
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3846 2388
Fax
Email
internist_omati@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Homeira Omati
Position
Resident
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3846 2388
Fax
Email
internist_omati@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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