Protocol summary

Study aim
Safety and immuno-modulation evaluation of treatment with intravenous and spinal cord injections of of autologous mesenchymal stem cells in patients with amyotrophic lateral sclerosis (ALS).
Design
Clinical trials without Contorol group , design for 13 patients.
Settings and conduct
Patients referred to clinics of Mashhad University of Medical Science and private sector visited by neurologist and by acquiring appreciation in case of having conditions, they will be enrolled.In Imam Reza Hospital of Mashhad the number 6-7 million MSC cell-derived Bone marrow in the form of Intrathechal (IT) and intravenous (IV) will be injected by a neurologist in the operating room and in completely sterile conditions to the patient . Before and after injection, patients will be evaluated in terms of immunological indices and clinical parameters.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ALS certified by neurologist , Rated 31-46 ALSFRS-R score.Patients should have been treated with a fixed dose of Rilozule 3 months ago. Patients should have no other chronic detrimental disease and do not use ventilator. Exclusion criteria: Patients with Malignancy, Patients with other chronic disruptive diseases, pregnancy.
Intervention groups
Eligible patients will be received 6-7million MSC-derived Bone marrow in intravenous and intra-spinal injections by a professional healthcare . The number of injected cells will be equal in both methods.In addition to cell therapy, patient will receive other common treatments according to the specialist physician.
Main outcome variables
ALSFRS-R evaluation:Using standard questionnaires completed by neurologist. FVC measurement : Using Spirometry test. Evaluation of serum levels of IL-1β-1, TNF-α, IL-10, IFN-γ : using Elisa kits. Evaluation of TCD4 + CD25 + lymphocyte cells using flow cytometry technique

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160809029275N2
Registration date: 2020-06-18, 1399/03/29
Registration timing: prospective

Last update: 2020-06-18, 1399/03/29
Update count: 0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51376276015
Email address
tavakolaj@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and immuno-modulation evaluation of treatment with intravenous and spinal cord injections of of autologous mesenchymal stem cells in patients with amyotrophic lateral sclerosis (ALS).
Public title
Stem cell therapy in ALS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ALS approved by neurologist with 31-46 ALSFRS-R score Patients should be treated with a fixed dose of Rilozule 3 months ago. Patients should not be detrimental to any other chronic disease and do not use ventilator.
Exclusion criteria:
Patients with malignancy Patients with other chronic disruptive diseases Pregnancy Others Neurodegenerative disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 15
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 Mashhad University of Medical Science
Street address
Daneshgah Ave., Qureshi Building, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-05-21, 1399/03/01
Ethics committee reference number
IR.MUMS.REC.1399.269

Health conditions studied

1

Description of health condition studied
Amyotrophic lateral sclerosis
ICD-10 code
G12.21
ICD-10 code description
Amyotrophic lateral sclerosis

Primary outcomes

1

Description
Earned score based on ALS-FRS test
Timepoint
Before, 1 and 3 months after injection of mesenchymal stem cells
Method of measurement
Standard Questionnaire

2

Description
Evaluation of serum levels of cytokines, IL-1 β, TNF-α, IL-10, IFN-γ
Timepoint
Before, 1 and 3 months after injection of mesenchymal stem cells
Method of measurement
Using Elisa method

3

Description
FVC measurement
Timepoint
Before, 1 and 3 months after injection of mesenchymal stem cells
Method of measurement
Using Spirometery test

4

Description
Evaluation of TCD4 + CD25 + lymphocyte cells.
Timepoint
Before, 1 and 3 months after injection of mesenchymal stem cells
Method of measurement
Using Flowcytometery technique

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group of receiving of Bone marroe-derived mesenchymal stem cells
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinics of Mashhad University of Medical sciences and private sector
Full name of responsible person
Dr.Amir Reza Borumand
Street address
Imam Reza Hospital, Imam Reza Sq., Ebne Sina Ave , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+98 51 3859 1057
Email
IRH.p.relations@mums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Qoreishi Building, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
Vresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
60
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Knowledge-based company of Pooya Gostar Parnia Iranian
Full name of responsible person
Dr.Seyed Jalil Tavakol Afshari
Street address
3rd Floor, Sadra Building, kafayi 1, Daneshgah Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3848 2194
Email
Parnia@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Knowledge-based company of Pooya Gostar Parnia Iranian
Proportion provided by this source
40
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Seysd Jalil Tavakol Afshari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Stem cell therapy
Street address
Bu-Ali Square,Bu-Ali Science and Technology Park, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2610
Fax
+98 51 3711 2596
Email
Tavakolaj@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Seyad Jalil Tavakol Afshari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Stem cell therapy
Street address
Bu-Ali square. Bu-Ali Science and Technology Park, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2610
Fax
+98 51 3711 2596
Email
Tavakolaj@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Seyad Jalil Tavakol Afshari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Stem cell therapy
Street address
Bu-Ali square. Bu-Ali Science and Technology Park, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2610
Fax
+98 51 3711 2596
Email
Tavakolaj@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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