Evaluation of neuro-inflammatory markers in patients with amyotrophic lateral sclerosis (ALS) after cell therapy with mesenchymal stem cells.
Design
Clinical trials without Contorol group , design for 21 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 Pastoor Hospital of Mashhad the number one million BM-MSC /kg BW 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 confirmed by a neurologist with an ALSFRS-R score between 31-46.
Patients must have been treated with a stable dose of Rilozule for the previous 3 months.
Patients should not have any other chronic diseases and should not use ventilators.
Patients in the age range of 18 to 75 years.
Exclusion criteria:
Patients with malignancy.
Patients with other chronic diseases.
pregnancy
Suffering from other neurodegenerative diseases.
Simultaneous participation in other clinical trials
Intervention groups
Eligible patients will receive one million autologous BM mesenchymal stem cells /Kg BW as intravenous and intrathecal injections (with equal volume) 3 times with one month interval by a specialist doctor. In addition to cell therapy, patients will also receive other common treatments according to the expert doctor's opinion.
Main outcome variables
Earned score based on ALS-FRS test
FVC measurement
Evaluation of serum levels of cytokines, TNFα , MCP-1, NFL, GDNF
Evaluation of MIR 206 , Mir338p, Mir133p expression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160809029275N5
Registration date:2024-05-02, 1403/02/13
Registration timing:retrospective
Last update:2024-05-02, 1403/02/13
Update count:0
Registration date
2024-05-02, 1403/02/13
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
2022-12-22, 1401/10/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
2022-12-22, 1401/10/01
Actual recruitment end date
2023-04-21, 1402/02/01
Trial completion date
2023-04-21, 1402/02/01
Scientific title
Evaluation of neuro-inflammatory markers for amyotrophic lateral sclerosis (ALS) patients before and after Mesenchymal Stem Cell (MSC) transplantation
Public title
Biomarkers evaluation following MSC therapy in ALS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ALS confirmed by a neurologist with an ALSFRS-R score between 31-46.
Patients must have been treated with a stable dose of Rilozule for the previous 3 months.
Patients should not have any other chronic diseases and should not use ventilators.
Patients in the age range of 18 to 75 years.
Exclusion criteria:
Patients with malignancy.
Patients with other chronic diseases.
pregnancy.
Suffering from other neurodegenerative diseases.
Simultaneous participation in other clinical trials
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
25
Actual sample size reached:
21
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
کمیته اخلاق دانشگاه علوم پزشکی مشهد
Street address
Daneshgah Ave., Qureshi Building, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-12-17, 1401/09/26
Ethics committee reference number
IR.MUMS.REC.1401.325
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 2 months after injection of mesenchymal stem cells
Method of measurement
Standard Questionnaire
2
Description
FVC measurement
Timepoint
Before, 1 and 2 months after injection of mesenchymal stem cells
Method of measurement
Using Spirometery test
3
Description
Evaluation of serum levels of cytokines, TNFα , MCP-1, NFL, GDNF
Timepoint
Before, 1 and 2 months after injection of mesenchymal stem cells
Method of measurement
Using Elisa method
4
Description
Evaluation of MIR 206 , Mir338p, Mir133p expression
Timepoint
Before, 1 and 2 months after injection of mesenchymal stem cells
Method of measurement
Using the Real Time PCR method
Secondary outcomes
empty
Intervention groups
1
Description
Eligible patients will receive one million autologous BM mesenchymal stem cells /Kg BW as intravenous and intrathecal injections by a specialist doctor. The number of injected cells will be equal in both methods. The number of injections is three times and they are performed at a distance of one month from each other (in months zero, one and two of the study). In addition to cell therapy, patients will also receive other common treatments according to the expert doctor's opinion.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Mashhad University of Medical Sciences and the private sector
Full name of responsible person
دکتر امیررضا برومند
Street address
Ahmad Aabad Ave, Pastor Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3844 0482
Email
Drboroumand2017@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
دکتر سید جلیل توکل افشاری
Street address
Daneshgah Ave., Qureshi Building, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3842 1023
Email
vce.em@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?