1) Objectives: Evaluation of the safety and feasibility intra-arterial injection of autologous stem cells derived from adipose tissue in stroke patients. 2) Design: In this study we will discuss a phase I clinical trial for the safety and feasibility injection of stem cell in patient's stroke. 3) Setting & Conduct: Processing of isolation of stem cells derived from adipose tissue 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 autologous stem cells derived from adipose tissue via intra-arterial route at the dose of1 million cells/kg in 2 min via angiocatheter during angiography). 4) Inclusion criteria: age30-80 ; MRI or CT scan with infarct in middle/anterior cerebral artery without hematoma; ischemic stroke within 7 -30 days before; GCS score > 8, NIHSS score 8 to20, Signed informed consent if the patient is unable to provide meaningful consent their guardian or legal. Exclusion criteria: The patient is in a coma; Evidence on neuroimaging (CT or MRI) of a brain tumor, cerebral edema with midline shift and unwillingness to provide written informed consent. 5)Intervention: Overall 4 patients will be enrolled and autologous stem cells derived from adipose tissue will be injected intra of autologous stem cells derived from adipose tissue.-arterial for all of them. After intervention, NIHSS and MRS score and also MRI will be evaluated. 6) Main outcome measures are Safety and feasibility of intra-arterial injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111427865N2
Registration date:2017-02-09, 1395/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-09, 1395/11/21
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
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the safety and feasibility of intra-arterial injection of autologous stem cells derived from adipose tissue in stroke patients.
Public title
Effect of adipose tissue stem cells in stroke patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Age range 30–80 years 2-Time of stroke onset known and treatment could be started within 7 days of onset. If the exact time of stroke is unknown when the symptoms of stroke have been observed to last referred 3-NIHSS score 8to20 4-CT and MRI images can approve stroke 5-Negative pregnancy test in women who are of childbearing age 6-Stroke confined to MCA territory on CT or MRI brain scana 7-All the study steps detailed to the patient and if the patient's consciousness the patient's relatives have to be explained 8-Signed informed consent if the patient is unable to provide meaningful consent their guardian or legal representative must give their consent to participate by signing the informed consent document. Exclusion criteria:1 2-Evidence on neuroimaging (CT or MRI) of a brain tumor, cerebral edema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction, and intraventricular, intracerebral, or subarachnoid hemorrhage 3-People who have difficulty accessing them in the future 4-Patients with evidence of life-threatening infection including (AIDS, hepatitis and cancer) 5-Renal dysfunction with creatinine .150 mmol/l 6-Before the stroke alone is not able to perform their daily activities 7-Blood glucose levels is not less than 3 mmol or more than 20 mmol 8-Female patients of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding 9-Patients who are participating in another clinical trial 10-Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to the study requirements.
Age
From 30 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
4
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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 Iran University of Medical Sciences
Street address
Besides Milad Tower-Hemat Highway-Tehran
City
Tehran
Postal code
Approval date
2016-11-12, 1395/08/22
Ethics committee reference number
IR.IUMS.REC.1395028575
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I63.5
ICD-10 code description
occlusion and stenosis of cerebral and precerebral arteries, resulting in cerebral infarction
Primary outcomes
1
Description
Score of NIHSS scale
Timepoint
On 2-24 hours,7days,1-3-6-12 month after cell injection
Method of measurement
NIHSS questionnaire (0-42) score
Secondary outcomes
1
Description
Create Rebleeding
Timepoint
On 2-24 hours,7days,1-3-6-12 month after cell injection
Method of measurement
MRI of brain
2
Description
Tumor Formation
Timepoint
Befor and after cell injection
Method of measurement
MRI WHOLE BODY DIFFUSION
3
Description
Rate of Epilepsy
Timepoint
On24 hours and7days after cell injection
Method of measurement
EEG
4
Description
MRS score
Timepoint
On 2-24 hours,7days,1-3-6-12 month after cell injection
Method of measurement
MRS questionnair with score 0-6
5
Description
Evaluation of structural brain function by MRI
Timepoint
On 2-24 hours,7days,1-3-6-12 month after cell injection
Method of measurement
Results of volume of infarction and lateral ventricles before and after cell injection by MRI
Intervention groups
1
Description
injection of Stem cells derived from adipose tissue in the middle cerebral artery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firozgar hospital
Full name of responsible person
Dr masod mehrpour
Street address
Firozgar hospital-Valiasr square-Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
seyedamirhosseini
Street address
Besides Milad Tower-Hemat Highway-Tehran
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyedamirhosseini
Position
PHD Student
Other areas of specialty/work
Street address
Besides Milad Tower-Hemat Highway-Tehran
City
Tehran
Postal code
Phone
+98 21 6693 6299
Fax
Email
amirhosseini1358@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
seyedamirhosseini
Position
phd stydent
Other areas of specialty/work
Street address
Tower-Hemat Highway-Tehran
City
Tehran
Postal code
Phone
+98 21 6693 6299
Fax
Email
amirhosseini1358@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
seyedamir hosseini
Position
phd student
Other areas of specialty/work
Street address
Tower-Hemat Highway-Tehran
City
Tehran
Postal code
Phone
+98 21 6693 6299
Fax
Email
amirhosseini1358@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)