Protocol summary

Summary
Cerebral palsy(CP) consisted of a group of nonprogressive disorders of brain injuries . and is one of the major problems of pediatric neurology and at the present time there is no standard medical or surgical treatment for it .Stem cell therapy is one of a new and hopeful therapeutic methods of CP .This study designed for the evaluation of therapeutic effects of intrathecal hematopoietic and mesenchymal stem cells derived from allogenic umbilical cord in improvement of developmental functions of spastic CP patients between 4-14 years old . Developmental conditions consisted of GMFM88 , GMFCS and Denver and spasticity according to Ashworth scale and brain imaging findings documented at the start and during the study period . The patients referred to neurology clinic of Children’s Medical Center . Suitable cases selected from patients with remarkable cerebral damage of non congenital origin in imaging .If parents after awareness of etiology and study design and even probable adverse effects have a consent , recruited . 108 cases will be recruited and randomly divided to 3 groups of 36 cases : hematopoietic stem cells derived from allogenic umbilical cord , Mesenchymal cells derived from allogenic umbilical cord and control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201706176907N13
Registration date: 2017-07-12, 1396/04/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-12, 1396/04/21
Registrant information
Name
Mahmoudreza Ashrafi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9252
Email address
ashrafim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences , Social welfare organization of Iran,Royan stem cell Technology , Hormozgn University of Medical Sciences, Stem cell iranian science and technolgy institute
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Scientific title
Evaluation of the efficacy of allogeneic umbilical cord derived hematopoietic stem cells and mesenchymal stromal cells in patients with spastic cerebral palsy on developmental function , A Clinical trial phase 2
Public title
effectes of umblical blood stem cells injection in the treatment of children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : 1-known cases of spastic cerebral palsy(diplegic, hemiplegic or quadriplegic ) 2- 4 - 14 years old 3 - Gross motor function classification bitween 2 -5 4- patient without seizure or with controled seizure disorder (for patient with suspected seizure EEG must de done before recruitment ) 5- evidence of definite abnormal imaging finding compatible with CP that is not congenital 6- informed consept is taken from their parents exclusion criteria: 1- patient with normal brain MRI 2- progressive neurologic diseases ( for example leukodystrophy and neurometabolic disease) 3-cortical malformations, genetic disorders such as brain dysgenesia secondary to metabolic causes or infections 4- other types of cerebral palsy including athethoid , atonic , ataxic , and mixed type 5- acute intercurrent infections such as HCV, HBV, HIV 6- malignancies 7- hemorrhagic diathesis , severe anemia ( HB less than 8 ) 8- ventilatore dependent pulmonary diseases : pneumonia , respiratory tract infections 9- renal insufficiency 10 - severe liver dysfunction 11- other bone marrow disorders
Age
From 3 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
None
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
در حال حاضر ندارد در حال اقدام هستیم
Secondary trial Id
ندارد
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of Medical Sciences
Street address
Keshavarz blvd Ghods street devision 6
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.TUMS.VCRREC.1996.2506

Health conditions studied

1

Description of health condition studied
spastic cerebral palsy
ICD-10 code
G80.9
ICD-10 code description

Primary outcomes

1

Description
motor development alteration with GMFM 88 score
Timepoint
begining , 1 month , 3 month ,6 month , 12 month
Method of measurement
questionairre

2

Description
improvement of motor function with GMFCS score
Timepoint
begining , 1 month , 3 month ,6 month , 12 month
Method of measurement
questionairre

3

Description
spasticity improvement of patients according to Ashworth scale
Timepoint
begining , 1 month , 3 month ,6 month , 12 month
Method of measurement
questionairre

4

Description
developmental status according to Denver screening test
Timepoint
begining, 1 month , 3 month ,6 month , 12 month
Method of measurement
questionairre

Secondary outcomes

1

Description
Decrement of brain lesion
Timepoint
at onset of study , end of study ( 1 year )
Method of measurement
MRI , MRS , DTI

2

Description
fever
Timepoint
24 hours , 48 hours , 72 hours
Method of measurement
axillary thermometer

3

Description
aseptic meningitis
Timepoint
first 3 days or any time signes occured
Method of measurement
LP

4

Description
hyper sensivity reactions
Timepoint
first week of injection
Method of measurement
physical exam

Intervention groups

1

Description
the group who would be injected intrathecally HSC o rmononuclear hematopoietic stem cell derived from umbilical cord ( 5 millions per Kg )
Category
Other

2

Description
the group who would be injected intrathecally MSC or mesenchymal stem cellls derived from umbilical cord ( 5 million per kg)
Category
Other

3

Description
attempeting for intrathecal injection simulating lumbar puncture without awareness of patient and evaluators
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
anahita majmaa
Street address
end of keshavarz Boulvar Gharib Street children's Medical Center
City
Tehran
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
masood yunesian
Street address
Keshavarz Boulvar , Ghods Street , Central organization
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
Tehran 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
stem cell iranian science and technolgy institute
Full name of responsible person
Amir ali Hamidie
Street address
Sheykh Bahaee street, Ladane street NUM 20
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
stem cell iranian science and technolgy institute
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

3

Sponsor
Name of organization / entity
ROYAN stem cell technology
Full name of responsible person
Morteza zarrabi
Street address
No. 24, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran.
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
ROYAN stem cell technology
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

4

Sponsor
Name of organization / entity
Welfare Organization of Iran
Full name of responsible person
Zahra Noparasst
Street address
Emam khomeyni square , Shaheed fayazbakhsh street Num 1121
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
Welfare Organization of Iran
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

5

Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Alireza moaedi
Street address
Shahid mohammadi Hospital , Jomhori eslami Boulvar
City
Bandarabass
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
Hormozgan 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

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran university medical science
Full name of responsible person
Anahita Majmaa
Position
pediatrician
Other areas of specialty/work
Street address
end of Keshavarze avenues , childrensmedicalcenter hospital
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 6612 9252
Fax
Email
majmaaa911@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university Medical Sciences
Full name of responsible person
Mahmoudreza Ashrafi
Position
Professor of Pediatric Neurology
Other areas of specialty/work
Street address
children's Medical Center
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 6612 9252
Fax
+98 21 6612 9252
Email
ashrafim@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University Medical Sciences
Full name of responsible person
Anahita Majmaa
Position
pediatrician
Other areas of specialty/work
Street address
end of Keshavarz Boulvar ,Gharib Street children's Medical Center
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 6612 9252
Fax
Email
majmaaa911@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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