A Clinical trial to evaluate the effects of intrapulmonary injection of bone marrow derived mononuclear cells along with pulmonary hypertension drugs on pulmonary pressure in patients with Eisenmenger syndrome
The purpose of this study is to determine the effect of intrapulmonary injection of stem cells on pulmonary artery pressure of patients with Einsenmenger syndrome whose heart defect has been repaired. This pilot study will be done on patients with previous ventricular septal defect and pulmonary hypertension who have underwent open heart surgery and have received routine medications for at least two years after surgery, but their pulmonary pressure hasn't decreased due to Eisenmenger syndrome. (about 5 patients)
In this study right side catheterism will be done for patients and pulmonary artery pressure, pulmonary vascular resistance and right ventricle output will be recorded. Then mononuclear cells derived from culture of bone marrow aspirated specimen will be injected in right and left lungs in equal amounts. After procedure patients will be on their previous routine medications. They will be evaluated one, three, and six months after procedure. Echocardiography and six minutes walking test will be done and patients' functional class will be checked before procedure and in follow up after that. At the end of six months, right catheterism will be done for them again and pulmonary artery pressure, pulmonary vascular resistance and right ventricle output will be recorded. Data obtained before and after the procedure will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080435442N1
Registration date:2017-10-03, 1396/07/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Pegah Banafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00d989177391399
Email address
banafi_p@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to evaluate the effects of intrapulmonary injection of bone marrow derived mononuclear cells along with pulmonary hypertension drugs on pulmonary pressure in patients with Eisenmenger syndrome
Public title
ٍٍEffect of intrapulmonary injection of stem cells in patients with pulmonary hypertention due to congenital heart defect whose heart disease has been repaired
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: operated VSD (ventricular septal defect) and pulmonary hypertension (Eisenmenger)؛ not improved pulmunary HTN 2years after surgery (despite recieving routine medical therapy)
Exclusion criteria: absence of consent؛ finding clot in heart؛ not tolerating catheterism
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences Managing Building, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2016-07-31, 1395/05/10
Ethics committee reference number
IR.SUMS.REC.1395.81
Health conditions studied
1
Description of health condition studied
Eisenmenger's syndrome
ICD-10 code
Q21.8
ICD-10 code description
other congenital malformation of cardiac septa
Primary outcomes
1
Description
pulmonary artery pressure
Timepoint
before intervention and 1month-3months-6months after procedure
Method of measurement
catheterism and echocardiography
2
Description
Pulmonary vascular resistance
Timepoint
before intervention and 1month-3months-6months after procedure
Method of measurement
catheterism and echocardiography
Secondary outcomes
1
Description
Right side cardiac output
Timepoint
Before intervention and 1month-3months-6months after the procedure
Method of measurement
echocardiography and catheterism
2
Description
patients' functional class
Timepoint
Before intervention and 1month-3months-6months after the procedure
Method of measurement
echocardigraphy and ECG and 6minutes walking test
3
Description
Results of 6 minute walking test
Timepoint
Before intervention and 1month-3months-6months after the procedure
Method of measurement
6 minute walking test
Intervention groups
1
Description
Bone marrow will be aspirated and cultured. Mononuclear cells will be derived. Cell extraction is based on ficoll based gradient method. The injectable sample is a cell suspension containing at least 20 million cells in 10 ml of physiologic serum as a cell carrier. The cell sample immediately after preparation (3-4 hours) is sent to the operating room in a sterile syringe with keeping the cold chain. Then these autologous mononuclear cells will be injected in both side pulmonary arteries by catheterism. The study has no control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza clinic
Full name of responsible person
Dr.Hamid Amoozgar
Street address
third floor, Emamreza Clinic, Namazee square, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahmeddini
Street address
Vice chancellor for research, 7th floor, Managing Building of Shiraz University of Medical Sceinces, Zand street, Shiraz, Iran
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Hamid Amoozgar
Position
Professor of Pediatric cardiology
Other areas of specialty/work
Street address
pediatric ward, first floor, Namazee hospital, Namazee square, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4298
Fax
Email
amozgah@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Hamid Amoozgar
Position
Professor of Pediatric cardiology
Other areas of specialty/work
Street address
pediatric ward, first floor, Namazee hospital, Namazee square, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4298
Fax
Email
amozgah@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pegah Banafi
Position
medical student
Other areas of specialty/work
Street address
School of Medicine, Shiraz University of Medical Sciences, Setad square, Shiraz, Iran
City
Shiraz
Postal code
Phone
00
Fax
Email
banafi_p@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)