Investigation of safety and efficacy of intrathecal and intravenous injection of umbilical cord-derived mesenchymal stem cells (UC-MSC) in patients with multiple sclerosis
Investigating the safety of intraspinal and intravenous injection of umbilical cord-derived mesenchymal stem cells (UC-MSC) in patients with multiple sclerosis based on the incidence of side effects and EDSS index
Design
Phase 1 clinical trial without randomization, without blinding (open-label) on 5 patients.
Settings and conduct
The study population consists of patients aged 18 to 55 years who are suffering from multiple sclerosis of SPMS type and have not responded to more than one line of treatment, and the EDSS of these patients should be 3 to 6. In addition to their classical treatment, all these 5 patients received 1 x 106 cells/kg of mesenchymal stem cells intravenously and 0.5 x 106 cells/kg intraspinally. Also, all patients received a booster dose of 0.5 x 106 cells/kg. They receive intrathecal injection 3 months later. The mesenchymal stem cells used are derived from the umbilical cord (UC-MSC). The place of study is the MS Clinic of Imam Khomeini Hospital Complex in Tehran.
Participants/Inclusion and exclusion criteria
McDonald's diagnostic criteria for multiple sclerosis.
RRMS or SPMS type of multiple sclerosis.
The expanded Disability Status Scale (EDSS) is between 3 and 6.
Intervention groups
In addition to their classical treatment, these 5 patients received 1 x 106 cells/kg of mesenchymal stem cells intravenously and 0.5 x 106 cells/kg intraspinally. All patients received a booster dose of 0.5 x 106 cells/kg intravenously. They receive a spinal cord 3 months later. The mesenchymal stem cells used are derived from the umbilical cord (UC-MSC).
Main outcome variables
Side effects; Disability (EDSS); Upper extremity motor skill performance; Cognitive function; Number of new brain lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161212031362N3
Registration date:2023-01-18, 1401/10/28
Registration timing:prospective
Last update:2023-01-18, 1401/10/28
Update count:0
Registration date
2023-01-18, 1401/10/28
Registrant information
Name
Mohammad Hossein Harirchian
Name of organization / entity
Iranian center of neurological research
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 8899
Email address
harirchm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of safety and efficacy of intrathecal and intravenous injection of umbilical cord-derived mesenchymal stem cells (UC-MSC) in patients with multiple sclerosis
Public title
Investigation of safety and efficacy of intrathecal and intravenous injection of umbilical cord-derived mesenchymal stem cells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
McDonald's 2017 diagnostic criteria for multiple sclerosis
Exclusion criteria:
Any history of severe disease that interferes with study results, such as cancer, severe kidney disease, liver disease, digestive disease, heart disease, or any uncontrolled disease
Cognitive Disorder, Inability in fill out the consent form voluntarily
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
Ethic Committee of Neuroscience Institute , Tehran University of Medical Sciences
Street address
Neuroscience Institute, Imam Khomeini Hospital complex; Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2022-11-11, 1401/08/20
Ethics committee reference number
IR.TUMS.NI.REC.1401.057
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 disability degree
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
EDSS index, functional examination of body systems in 8 aspects: pyramidal, cerebellar, brainstem, sensory, urinary and digestive, visual, cerebral and other aspects of a person's ability to walk
2
Description
Walking performance
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Questionnaire - Timed 25-Foot Walk, the time a person can walk 25 feet, a maximum time of 3 minutes
3
Description
Upper extremity motor skill performance
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Questionnaire 9 hole peg test, the time that a person can put the pegs in the hole and then take them out of the hole. Maximum time is 5 minutes
4
Description
Cognitive function
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Paced Auditory Serial Addition Test (PASAT) questionnaire, a number is said every 3 seconds and the person must add two consecutive numbers together. The number of correct answers is between 0-60
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patient with multiple sclerosis; A) Intrathecal injection of mesenchymal stem cells: 1. Patient admission to the hospital. It is better to hospitalize the patients 24 to 48 hours after the injection of mesenchymal stem cells. 2. Mesenchymal stem cells are delivered in 3 to 4 cc of normal saline solution, and the injection should be performed within 6 hours. 3. Before injection, place the solution containing the cells in the room for 20 minutes to reach room temperature. 4. Do not use alcohol or betadine to sterilize the injection area because it damages the cells hit. 5. Shake the solution gently to homogenize the cells. 6. The 24 g spinal needle is placed in the standard position between the 2nd and 5th lumbar vertebra. 7. After collecting 3-5 ccs of CSF sample for baseline analysis, the solution containing mesenchymal stem cells is injected into the CSF with gentle hand pressure within 1 to 2 minutes, and then 1CC Ringer lactate or normal saline is injected. 8. After the cell injection, the patient is placed in Trendelenberg position 10 degrees and every 15 minutes is rotated on its sides for 2 hours to maximize even distribution of cells in the CSF. 9. Antibiotics can be prescribed to prevent meningitis. B) Intravenous injection of mesenchymal stem cells: 1. Patient admission to the hospital. It is better to hospitalize the patients 24 to 48 hours after the injection of mesenchymal stem cells. 2. Mesenchymal stem cells are delivered in 10 ccs of normal saline and 5% albumin solution and must be injected within 6 hours after delivery. 3. Before injection, place the solution containing the cells in the room for 20 minutes to reach room temperature. 4. Gently shake the solution to homogenize the cells. 5. Remove the cells with a 10 cc syringe and inject them into 100 to 200 cc of normal saline serum. 6. The serum should be infused into the patient's vein within 20 minutes. 7. It is recommended to prescribe agonists of H1 and H2 receptors to prevent allergic reactions before injection and monitor patients for 2 hours. 8. Before and after cell injection, patients should receive 5000 units of heparin (10000 units in total).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Center of Neurological Research
Full name of responsible person
Mohammad hossein Harirchian
Street address
Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2398
Email
icnr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Qods St, Keshavarz BLVD
City
تهران
Province
Tehran
Postal code
4979133141
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad hossein Harirchian
Position
Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard
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
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
Reporting the results of "Investigation of safety and efficacy of intrathecal and intravenous injection of umbilical cord-derived mesenchymal stem cells (UC-MSC) in patients with multiple sclerosis" investigation as 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
harirchn@hotmail.com
harirchm@tums.ac.ir
What processes are involved for a request to access data/document
Within one month after the request, your request will be reviewed and the result will be announced.