Safety evaluation of umbilical cord derived mesenchymal stem cells in multiple sclerosis patients
Design
This study is a phase 1 clinical trial, the main purpose of which is to investigate the safety and efficacy of placental mesenchymal stem cells in 5 patients with secondary progressive MS without blinding.
Settings and conduct
The injection of mesenchymal stem cells intravenously at the rate of one million per kilogram of body weight is performed without stopping the monoclonal antibody drugs at Baqiyatullah Hospital in Tehran.
Participants/Inclusion and exclusion criteria
1) Age between 18 and 55
2) Diagnosed of MS based on the criteria given by McDonalds
3) EDSS score between 2 and 7 after at least 3 months have passed since the last attack
4) secondary progressive patients who are treated with monoclonal antibodies
Intervention groups
At the rate of one million per kilogram of body weight (6*10) stem cells are injected into patients, and this amount is administered intravenously (IV).
Main outcome variables
Side effects of MSCs on neurophysiological functions, clinical symptoms and immunological processes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230806059052N1
Registration date:2023-09-18, 1402/06/27
Registration timing:registered_while_recruiting
Last update:2023-09-18, 1402/06/27
Update count:0
Registration date
2023-09-18, 1402/06/27
Registrant information
Name
Mohamad mahdi Esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 81261
Email address
mohamadmahdi.esmaeili.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-09-13, 1403/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety evaluation of umbilical cord derived mesenchymal stem cells in multiple sclerosis patients
Public title
Safety evaluation ofstem cells in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
MS diagnosed based on McDonalds criteria
Secondary progressive patients who are treated with monoclonal antibodies
EDSS score between 2 and 7 after at least 3 months have passed since the last attack
Exclusion criteria:
Active proliferative retinopathy
Poor diabetes control (HbA1c greater than 8.5)
Renal failure (creatinine more than 2.5)
Infection (WBC more than 15000 and/or body temperature more than 38 degrees Celsius)
Organ transplant history
Active malignancy or its history in the past
Cardiovascular disease
pregnant women
Having a positive PCR test for Covid-19
Mental disorders
Age
From 18 years old to 55 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
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
Research Ethics Committees of Baqiyatallah Hospital
Street address
Sheikh Baha'i
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-07-23, 1402/05/01
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.031
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
The danger and side effects of mesenchymal stem cell transplantation in terms of causing pain
Timepoint
injection day and 1, 3, 6 and 12 months after stem cell injection
Method of measurement
Patient self-report
2
Description
Degree of disability
Timepoint
before injection and 1, 3 and 12 months after stem cell injection
Method of measurement
with EDSS index
3
Description
Safety and side effects of mesenchymal stem cell transplantation in terms of hypersensitivity
Timepoint
injection day and 1, 3, 6 and 12 months after stem cell injection
Method of measurement
Clinical observation
4
Description
The safety of stem cell injection in terms of causing infection and inflammation
Timepoint
injection day and 1, 3, 6 and 12 months after stem cell injection
Method of measurement
CBC ESR CRP
5
Description
The safety of stem cell injection in terms of damage to the liver
Timepoint
injection day and 1, 3, 6 and 12 months after stem cell injection
Method of measurement
AST ALT
6
Description
The safety of stem cell injection in terms of kidney dysfunction
Timepoint
injection day and 1, 3, 6 and 12 months after stem cell injection
Method of measurement
BUN Creatinine U/A
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The tests before the injection are performed on an outpatient basis and the patient is admitted to the hospital on the day of the injection, and the patient will be hospitalized for 24 hours after the injection. Mesenchymal stem cells will be injected at about 1x106 MSC/Kg, which is as follows: Mesenchymal stem cells will be delivered in 10 cc of normal saline and 5% albumin solution and will be injected over a period of 6 hours. Before injection, it will be in the room for 20 minutes to reach the ambient temperature. We will gently shake the solution until the cells are homogenized, remove the cells with a 10 cc syringe and inject 100 to 200 cc of normal saline serum. The serum is infused into the patient's vein within 20 minutes. Patients receive 5000 units of heparin before and after cell injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyat Allah Al-Azam Hospital
Full name of responsible person
Dr. Seyyed Javad Hosseini Nejad Anbaran
Street address
Sheikh Baha'i
City
tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
Info@Mail.bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Abbas Ali Imani Fuladi
Street address
Sheikh Baha'i
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
Info@Mail.Mbmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyyed Javad Hosseini Nejad Anbaran
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Sheikh Baha'i
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 3832
Email
Javadhoseini1360@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyyed Javad Hosseini Nejad Anbaran
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Sheikh Baha'i
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 3832
Email
Javadhoseini1360@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohamad Mahdi Esmaeili Araghi
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sheikh Baha'i۱۱
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 3832
Email
Mohamadmahdi.esmaeili.a@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Clinical study report of the research plan ((Evaluation of the safety of mesenchymal stem cells derived from the umbilical cord in the treatment of patients with multiple sclerosis)) in the form of an article.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is not possible to access the data for the use of other people.
From where data/document is obtainable
Javadhoseini1360@gmail.com
What processes are involved for a request to access data/document
Within one months after the request, your request will be reviewed and the result will be announced.