Protocol summary

Summary
1) Objectives: Evaluation of the safety and feasibility of delivering human umbilical cord mononuclear cells (cbMNCs) via catheter to the proximal end of the lesion artery in patients with sub-acute stroke in the territory of the middle cerebral artery is the main objective of this study 2)Design: In this study we will discuss a phase I clinical trial for the safety and feasibility of cbMNCs on the possible phenotypic changes in patients with sub-acute ischemic stroke.3)Setting & Conduct: Processing of isolation of cbMNCs under GMP condition, Conducting quality control tests, intra-arterial infusion of these cells between 7 to 30 days after onset of stroke (one injection of cbMNCs via intra-arterial route at the dose of 3 million cells/kg in 2 min via angiocatheter during angiography). 4) Inclusion criteria: age 18-75; MRI or CT scan with infarct in middle/anterior cerebral artery without hematoma; ischemic stroke within 7 -30 days before; GCS score > 8; BI score ≤50, NIHSS score ≥7; inability to raise arms to 90 degrees; stable medical condition for more than 48 hours. Exclusion criteria: lacunar syndrome; intubation; posterior circulation stroke; inaccessibility for follow up; allergy to local anesthetic; unwillingness to provide written informed consent 5)Intervention: Overall 4 patients will be enrolled and allogeneic cbMNCs will be injected intra-arterial for all of them. After intervention, NIHSS, MRS and BI score and also MRI will be evaluated. 6) Main outcome measures are Safety and feasibility of allogeneic cbMNCs intra-arterial injection.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016051327865N1
Registration date: 2016-11-08, 1395/08/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-08, 1395/08/18
Registrant information
Name
Masoud Mehrpour
Name of organization / entity
Firoozgar General Hospital, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1201
Email address
azeditehrani.f@tak.iums.ac.ir
Recruitment status
recruiting
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences; Iranian council for development of Stem cell sciences & Technologies, Vice presidency for Science and Technology
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Scientific title
Evaluation of the safety and feasibility of delivering human umbilical cord mononuclear cells (cbMNCs) via catheter to the proximal end of the lesion artery in patients with sub-acute stroke in the territory of the middle cerebral artery
Public title
The Safety and feasibility of Intra-Arterial Stem Cell Therapy In Patients with Sub-Acute Stroke
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: age: 18-75; MRI or CT scan with infarct in middle/anterior cerebral artery without hematoma; ischemic storke with 7 -30 days before; Glasgow Coma Scale score >8; BI score of ≤50, National Institute of Health stroke scale (NIHSS) score of ≥7; inability to raise arms to 90 degrees; stable condition more than 48 hours, normal body temperature; normal blood pressure with mean arterial pressure<125 mmHg (with systolic blood pressur>90 mmHg); normal blood sugar<200 mg/dl; normal urea/electrolyte. Exclusion criteria: lacunar syndrome; intubation; posterior circulation stroke; morbidity likely to limit survival to less than 3 years; pre-stroke disability leading to dependence on others for activity of daily living; inaccessibility for follow up; allergy to local anesthetic; unwillingness to provide written informed consent; symptoms suggestive of acute cardiac; hepatic or renal disease; pregnancy; HIV positivity; participation in any other trial; poor access vessel angiography; Fever.
Age
From 18 years old to 75 years old
Gender
Both
Phase
1
Groups that have been masked
None
Sample size
Target sample size: 4
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
14665-354
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.IUMS.REC.1395.27803

Health conditions studied

1

Description of health condition studied
Ischemic stroke
ICD-10 code
I63.5
ICD-10 code description
Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries

Primary outcomes

1

Description
Score of NIHSS scale
Timepoint
On 0, 30th, 90th and 180th days after cell injection
Method of measurement
NIHSS questionnaire (0-42) score

Secondary outcomes

1

Description
Rate of Epilepsy
Timepoint
On 90th and 180th day after injection
Method of measurement
EEG

2

Description
MRS score
Timepoint
On 0, 90th and 180th days after injection
Method of measurement
MRS questionnair with score 0-6

3

Description
BI score
Timepoint
On 0, 90th and 180th days after cell injection
Method of measurement
BI questionnaire with sore (0-100)

4

Description
Evaluation of structural brain function by MRI
Timepoint
On 0, 30th, 90th and 180th days after injection
Method of measurement
Results of volume of infarction and lateral ventricles before and after cell injection by MRI

Intervention groups

1

Description
Intervention: Injection of stem cells into middle cerebral artery during angiography (one injection of cbMNCs via intra-arterial route at the dose of 3 million cells/kg in 2 min)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar General Hospital, Iran University of Medical Sciences
Full name of responsible person
Masoud Mehrpour
Street address
Karimkhan Avenue, Behafarin Street
City
Tehran
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Moosavi
Street address
5th floor, Central Organization of Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Country
Iran (Islamic Republic of)
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 and Technology, Iran University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Iranian council for development of Stem cell sciences & Technologies, Vice presidency for Science an
Full name of responsible person
Dr. Ramin Heshmat
Street address
Ladan Alley, Sheikh Bahayi Shomali Avenue, Mollasadra Avenue
City
Tehran
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian council for development of Stem cell sciences & Technologies, Vice presidency for Science an
Proportion provided by this source
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
Department of Neuroscience, Faculty of Advanced Technologies in Medicine, Iran University of Medical
Full name of responsible person
Fereshteh Azedi Tehrani
Position
PhD Candidate
Other areas of specialty/work
Street address
Faculty of Advanced Technologies in Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
14665-354
Phone
+98 21 8670 4698
Fax
+98 21 8670 4698
Email
fazeditehrani@gmail.com, azeditehrani.f@tak.iums.ac.ir
Web page address
http://fatim.iums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, Firoozgar General Hospital
Full name of responsible person
Masoud Mehrpour
Position
MD, Neurologist, Interventionist
Other areas of specialty/work
Street address
Behafarin Avenue, Karimkhan Street
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1593747811
Phone
+98 21 8214 1201
Fax
+98 21 8894 2622
Email
mehrpr@yahoo.com
Web page address
http://firoozgar.iums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Department of Neuroscience, Faculty of Advanced Technologies in Medicine, Iran University of Medical
Full name of responsible person
Fereshteh Azedi Tehrani
Position
PhD Candidate
Other areas of specialty/work
Street address
Faculty of Advanced Technologies in Medicine, Iran University of Medical Sciences,Shahid Hemmat Highway
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
14665-354
Phone
+98 21 8670 4698
Fax
+98 21 8670 4698
Email
fazeditehrani@gmail.com, azeditehrani.f@tak.iums.ac.ir
Web page address
fatim@iums.ac.ir

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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