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Studying the effect of bone marrow mesenchymal stem cell injection into the subarachnoid space on improvement and reduction of complications in spinal cord injured patients

Protocol summary

Summary
Main outcome: The safety and effect of mesenchymal stem cell therapy on spinal cord injured patients will be assessed. Design: 30 patients with spinal cord injury will be selected and will be divided randomly into two groups. Around 10 million cells (three times) will be injected; MRI and physical assessments before and after cell therapy will be done by a physician who does not know the groups. Setting and conduct: Cells will be isolated from bone marrow of patient under aseptic conditions; cells will be culture in DMEM high glucose until proliferation and the mesenchymal stem cell type will be identified by immunostaining. After collection of enough mesenchymal stem cells they will be injected in to the patient's subarachnoid space. Participants, including major eligibility criteria: Patients must have 13-60 years old, patients must not have fever, convulsion and meningitis and any other infectious disease, the health condition of the patients must be stable, patients must have self control on breath, by occurrence of any side effect such as fever, convulsion or tumor that patient will be excluded from study. Interventions: Patients will have one bone marrow puncture and three subarachnoid injections of stem cells (10million/each). Variables: Main variables are: improvement in sense and motor function, MRI of injury size and type, physical examinations results, effect of each injection on improvement , effect of age on improvement, control on urination and defecation, tumor formation, fever and convulsion and any other complication or side effect occurrence will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013050813267N1
Registration date: 2014-02-06, 1392/11/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-02-06, 1392/11/17
Registrant information
Name
Farshad Homayouni Moghadam
Name of organization / entity
Royan Institute for Biotechnology
Country
Iran (Islamic Republic of)
Phone
Email address
f_homayounim@yahoo.com
Recruitment status
Recruitment complete
Funding source
Ali-Ebne Abitaleb Faculty of Medicine, Islamic Azad University, Yazd Branch
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of bone marrow mesenchymal stem cell injection into the subarachnoid space on improvement and reduction of complications in spinal cord injured patients
Public title
Studying the effect of bone marrow mesenchymal stem cell injection into the subarachnoid space on improvement and reduction of complications in spinal cord injured patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: filling the questionnaire by patient and his/her family; age 13-60; no more than 3 months passed from injury date, no history of cancer in patient and his family; no history to other chronic disorder; no other acute disease at present; self control on breathing; no contribution in the other studies; no convulsion and fever; no infectious diseases in patient like AIDS and hepatitis, and meningitis. Exclusion criteria: patient request; occurrence of fever and convulsion after cell therapy, occurrence of any other complication; infection, instability of patient's health conditions ; worsening of the patient's disease.
Age
From 13 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Iranian Ministry Of Health Ethic Commitee
Street address
Tehran, Azady Boulevard
City
Tehran
Postal code
Approval date
2013-03-14, 1391/12/24
Ethics committee reference number
1- k91p/69

Health conditions studied

1

Description of health condition studied
Spinal Cord Injury
ICD-10 code
T09.3
ICD-10 code description
Injury Of Spinal Cord, Level Unspecified

Primary outcomes

1

Description
Evaluation of Generation of Ectopic Tissue Such as Tumor After Stem Cell Therapy
Timepoint
Three months after third injection
Method of measurement
MRI; Physical Examination; Biochemical Tests About Presence of Ectopic Tissue or Tumor in Patients

Secondary outcomes

1

Description
Improvement In Somatic Sensation And Control Of Bladder , And Motor Function Improvements
Timepoint
1 Month
Method of measurement
Physical Examination

Intervention groups

1

Description
In intervention group, at first bone marrow aspiration (10ml) will be done and mesenchymal stem cells will be collected using centrifuge and Ficoll solvent. Cells will be cultured and after proliferation they will be collected by trypsination and microbial, quality and quantity analysis will be done on them. Collected cells with the quantity of 10-20 million cells will be solved in 5ml distilled water, and will be injected slowly (5 minutes) to sub arachnoid space of patient using lumbar puncture technique by anesthesiologist in operating room and in sterile conditions. Each patients will have 3 injections with near to 1 month interval between them.
Category
Treatment - Surgery

2

Description
In control group just vehicle of cells (distilled water) with the same volume of intervention group (5ml) will be injected to the sub arachnoid space of patients. Injecting solvent will be injected slowly (5 minutes) and by anesthesiologist in the operating room and in sterile conditions. Each patient in this group will receive 3 injections by one month interval between them. Bone Marrow aspiration will not perform in this group but just the action of bone marrow aspiration will be simulated in the operating room for them.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Yazd University Of Medical Sciences, Neurobiomedical Research Center
Full name of responsible person
Farshad Homayouni Moghadam, Hamid Hobobati
Street address
Yazd, Shohadaye Gomnam Boulevard, Shahid Sadoughi Yazd University of Medical Sciences, Neurobiomedical Research Center
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi Yazd University Of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Fatemeh Ezodini
Street address
Shahid Sadoughi Yazd University Of Medical Sciences, Vice Chancellor for Research, Bahonar Street
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi Yazd University Of Medical Sciences, Vice Chancellor for Research
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
Shahid Sadoughi Yazd University Of Medical Sciences, Yazd, Iran
Full name of responsible person
Hamid Hobobati
Position
Neurosurgeon
Other areas of specialty/work
Street address
Yazd, Shahid Sadoughi Yazd University Of Medical Sciences, School Of Medicine
City
Yazd
Postal code
8915173143
Phone
+98 35 1820 3410
Fax
Email
hh1358@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi Yazd University Of Medical Sciences
Full name of responsible person
Farshad Homayouni Moghadam
Position
PhD of Physiology, Stem Cell Researcher
Other areas of specialty/work
Street address
Yazd, Shohadaye Gomnam Boulevard, Shahid Sadoughi Yazd University Of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 1820 3411
Fax
Email
f_homayounim@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department Of Physiology, Shahid Sadoughi Yazd University Of Medical Sciences
Full name of responsible person
Farshad Homayouni Moghadam
Position
PhD of Physiology, Stem Cell Resaercher
Other areas of specialty/work
Street address
Shahid Sadoughi Yazd University Of Medical Sciences, Shohadaye Gomnam Boulevard
City
Yazd
Postal code
Phone
+98 35 1820 3412
Fax
Email
f_homayounim@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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