In this study, investigators aimed to assess safety and efficasy of intrathecal injection of autologous mesenchymal stem cells in patients with Amyotrophic Lateral Sclerosis (ALS)
Design
Clinical trial without control group
Settings and conduct
Patients referred to neuromuscular clinic of Golestan hospital of Ahvaz are visited by a neurologist and patients with definite or probable ALS based on revised ELEscorial criteria will enter the study. All patients sign the informed consent prior to inclusion in the study. In Shafa hospital of Ahvaz bone marrow aspiration is performed and autologous mesenchymal stem cells are isolated. Patients are received bone marrow mesenchymal stem cells via lumbar puncture into the cerebrospinal fluid. Patients are monitored before and after treatment, potential adverse reactions are assessed, and the clinical outcome is evaluated by Revised ALS Functional Rating Scale (ALSFRS-R) and Forced Vital Capacity (FVC)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed as definite or probable ALS disease according to ELEscorial criteria, Time passed since onset of symtoms till inclusion be 3 years or less, ALSFRS-R score more than 26, FVC more than 40%, An age range of 25 to 70 years; Exclusion criteria: any major systemic disease, any coexisting neurodegenerative disease, pregnancy or lactation
Intervention groups
Eligible patients are received bone marrow mesenchymal stem cells via lumbar puncture into the cerebrospinal fluid.
Main outcome variables
ALSFRS-R evaluation: using standard questionnaires completed by neurologist. FVC measurement: using spirometry test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200828048551N1
Registration date:2020-09-09, 1399/06/19
Registration timing:registered_while_recruiting
Last update:2020-09-09, 1399/06/19
Update count:0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Fatemeh Houshmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
hooshmandf66@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-24, 1398/12/05
Expected recruitment end date
2020-09-26, 1399/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficasy and safety of intrathecal injection of autologous mesenchymal stem cells in patients with amyotrophic lateral sclerosis (ALS)
Public title
Efficasy and safety of intrathecal injection of autologous mesenchymal stem cells in patients with amyotrophic lateral sclerosis (ALS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed as definite or probable ALS disease according to EL Escorial criteria
ALSFRS-R more than 26
FVC more than 40%
age 25-70 years
Time passed since onset of the symptoms till inclusion be 3 years or less
Exclusion criteria:
Any major systemic disease
Any coexisting neurodegenerative disease
No other major pathology in brain or spinal cord
pregnancy or lactation
Age
From 25 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
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 Ahvaz University of Medical Sciences
Street address
Ahvaz university of medical sciences, Farvardin Ave, Ahvaz