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).
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