The efficacy of intramyocardial injection of bone marrow-derived mesenchymal and CD133+ stem cells on improvement of cardiac ejection fraction in patients undergoing CABG in Shariati Hospital
Main Objective: Assessment of the efficacy of intramyocardial injection of bone marrow-derived mesenchymal and CD133+ stem cells on improvement of cardiac Ejection Fraction (EF) in patients undergoing Coronary Artery Bypass Surgery (CABG). This Study will be carried out as a clinical trial without control group, enrolling 9 patients considering inclusion and exclusion criteria. After selection of patients and taking informed consent from them and completing necessary tests and stress echocardiography and scintigraphy Radio-nucleotide Scan, a sample of bone marrow is taken to prepare mesenchymal and CD133+ cell. At the time of open heart surgery, 1ml of prepared cells is injected into myocardium around the scar. Patients are followed with physical examination, stress echocardiography and scintigraphy Radio-nucleotide Scan in 1 and 6 months after CABG.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902113799N2
Registration date:2010-05-26, 1389/03/05
Registration timing:na
Last update:
Update count:0
Registration date
2010-05-26, 1389/03/05
Registrant information
Name
Nasim Shayan
Name of organization / entity
Cardiac Transplantation Research Center (CTRC)
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3037
Email address
ctrc@tums.ac.ir
Recruitment status
Not enough for processing
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-09-01, 1390/06/10
Expected recruitment end date
2009-03-19, 1387/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of intramyocardial injection of bone marrow-derived mesenchymal and CD133+ stem cells on improvement of cardiac ejection fraction in patients undergoing CABG in Shariati Hospital
Public title
The efficacy of intramyocardial injection of bone marrow-derived mesenchymal and CD133+ stem cells on improvement of cardiac ejection fraction in patients undergoing CABG in Shariati Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1- Candidate for Coronary Artery Bypass Surgery (CABG)
2- History of Myocardial Infarction in 2-12 weeks ago
3- Age: 30-70 years
4- Ejection Fraction (EF) < %40 in Doppler Echocardiography
5- Presence of Akinesia in Doppler Echocardiography
6- Informed Consentience for this research
Exclusion Criteria:
1- Age < 30 yrs. or >70 yrs.
2- Unsuitable for Coronary Artery Bypass Surgery (CABG)
3- Patients with severe co-morbidity or history of open heart surgery
4- Absence of Scar in Scintigraphy Radio-nucleotide Scan
5- Patient in cardiac shock or needs for emergency heart surgery
6- Patient with moderate to severe valvular disease
7- In-consentience for this research
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
9
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
DDRC Ethics Commitee
Street address
Shariati Hospital
City
Tehran
Postal code
Approval date
2009-03-01, 1387/12/11
Ethics committee reference number
FWA00001331; DHHS-IRB00001641
Health conditions studied
1
Description of health condition studied
Chronic ischemic heart Disease
ICD-10 code
I25.2
ICD-10 code description
Myocardial Infarction
Primary outcomes
1
Description
Cardiac Scan Findings
Timepoint
before and 6 months after Surgery
Method of measurement
scintigraphy Radio-nucleotide Scan
2
Description
Functional Class
Timepoint
before and 1 & 6 months after Surgery
Method of measurement
Medical History and physical examination
3
Description
Ejection Fraction (EF)
Timepoint
before and 6 months after Surgery
Method of measurement
Stress Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Injection of Stem cell in Myocard
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Mohammad Rezaei
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Laleh Hospital
Full name of responsible person
Dr MohammadReza MohammadHasani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Technology cooperation office of Persidency
Full name of responsible person
Dr Seyed Majid Manavi
Street address
No. 9, Golha Blvd., Sattarkhan Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Technology cooperation office of Persidency
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
Cardiac Transplantation Research Center (CTRC)
Full name of responsible person
Mohammad Rezaei MD
Position
CTRC Research Supervisor / MD
Other areas of specialty/work
Street address
Shariati Hospital
City
Teharn
Postal code
Phone
+98 21 8863 3037
Fax
+98 21 8490 2512
Email
ctrc@tums.ac.ir; mh_rezaei@yahooc.om
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cardiac Transplantation Research Center (CTRC)
Full name of responsible person
Mohammadreza Mohammadhasani MD
Position
Assistant professor of Cardiology
Other areas of specialty/work
Street address
Laleh Hospital
City
Teharn
Postal code
Phone
+98 21 8863 3037
Fax
+98 21 8490 2512
Email
ctrc@tums.ac.ir; mohamadhasani@email.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cardiac Transplantation Research Center (CTRC)
Full name of responsible person
Mohammad Rezaei MD
Position
CTRC Research Supervisor / MD
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8863 3037
Fax
+98 21 8490 2512
Email
ctrc@tums.ac.ir; mh_rezaei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)