Safety of Intranasal Spray Containing the Conditioned Medium of Mesenchymal Stem Cells Derived from Umbilical Cord Wharton's jelly in Alzheimer's Disease (Mild to Moderate) in phase 1 of a clinical trial
An evaluation of the safety of IN of CM Derived from Umbilical Cord WJMSCs in Alzheimer’s patients
Design
Clinical trial with intervention groups (before and after), without blinding and randomization, Prism software for data analysis, phase 1 on 9 patients
Settings and conduct
-Interventional, Pre-Post, Within-group studies.
-Patients referring to the Brain and Cognition Clinic (Firouzgar Hospital IUMS) & written consent from
Sampling: Random& Convenience
-Isolation of CM
Steps: phase 1,2 and 3
Until complications in a dose more than 2.3 or 1.6, (toxic dose) the lower dose (safe dose & tolerated).
Participants/Inclusion and exclusion criteria
9 patients with mild to moderate AD dementia (Phase 1)
Inclusion:
MMSE Score:18-24
Males and Females (60 to 85 Years)
Exclusion:
Cancer & Mental disorders
Intervention groups
3 patients in each group (n=3)
Group 1: 1cc CM
Group 2: 2cc CM
Group 3: 3cc CM
Main outcome variables
Primary: Adverse Events & Changes in Biomarkers
Secondary: Cognitive Function Events (IADL & MoCA)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240131060870N1
Registration date:2024-02-19, 1402/11/30
Registration timing:prospective
Last update:2024-02-19, 1402/11/30
Update count:0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Setareh Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 9103 4580
Email address
strhai632@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-15, 1403/01/27
Expected recruitment end date
2025-04-16, 1404/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety of Intranasal Spray Containing the Conditioned Medium of Mesenchymal Stem Cells Derived from Umbilical Cord Wharton's jelly in Alzheimer's Disease (Mild to Moderate) in phase 1 of a clinical trial
Public title
Investigating the Effect of Intranasal Spray Containing Conditioned Medium from Umbilical Cord in Alzheimer's Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have brain structural changes based on MRI and doctor's diagnosis, which confirms their Alzheimer's dementia.
Gender and Age: men and women between 60 and 85 Y.
Diagnosis of Mild to Moderate Alzheimer's dementia at least 6 months before the start of the study.
MMSE (Mini-Mental State Examination) Score: 10 and 24 at the time of starting the study
Exclusion criteria:
Cancer patients who have been diagnosed in the last 5 years.
Patients who cannot undergo MRI due to their condition.
People with mental disorders
Have diseases such as vitamin B12 deficiency, diabetes, hypo/hyperthyroidism, and hepatitis.
History of cell therapy in the last 6 months.
Subjects who have participated in another clinical study within 3 months before the start of this study.
History of brain neoplasm.
Age
From 60 years old to 85 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
9
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Convenience Sampling
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Ethics Committee in Biomedical Research, Ethics in Research Working Group, Research and Technology Vice President, Central Headquarters Building, Iran University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-01-06, 1402/10/16
Ethics committee reference number
IR.IUMS.REC.1402.885
Health conditions studied
1
Description of health condition studied
Mild to moderate phase ,Alzheimer's patients, Alzheimer Disease, AD, Dementia
ICD-10 code
G30.1
ICD-10 code description
Diseases, Nervous System, Degenerative, Alzheimer's Disease, Late-onset, After the age of 65, AD, Dementia, Neurodegenerative, Central nervous system, CNS
Primary outcomes
1
Description
Fever
Timepoint
Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy
Method of measurement
Thermometer
2
Description
Headache
Timepoint
Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy
Method of measurement
Visual Analogue Scale (VAS)
3
Description
Dizziness, Nausea, and Vomiting
Timepoint
Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy
Method of measurement
Dizziness Questionnaire: is a 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap. Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0
4
Description
Pro-inflammatory cytokines: IL-1β, TNF-α and IL-6
Timepoint
Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy
Method of measurement
Human interleukin ELISA kit: designed for quantitative measurement of β1, IL-6 and TNF alpha in serum, plasma, cerebrospinal fluid and cell culture supernatant samples. This kit is designed and produced using monoclonal antibodies against human interleukins. Therefore, it is not used in measuring similar animal cases.
5
Description
Growth Factors:GF:TGF-β and BDNF
Timepoint
Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy
Method of measurement
ELISA kit Human TGF-B and BDNF: designed to detect TGF-β and BDNF in tissue samples, serum, plasma, cerebrospinal fluid and human cell culture supernatant.
6
Description
Protein Amyloid beta (Aβ)
Timepoint
Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy
Method of measurement
Blood Sample: Measurement of beta-amyloid plasma level by blood test
Secondary outcomes
1
Description
The instrumental Activities of Daily Living Scale (IADL) is used to assess a patient's independent living skills and measures.
Timepoint
0 ,2 week,1 and 3 month after CM therapy
Method of measurement
IADL Paper Questionnaire: which has 18 points.
2
Description
Montreal Cognitive Assessment Test (MOCA): was designed as a rapid screening tool for "mild cognitive impairment" and "Alzheimer's disease".
Timepoint
0 ,2 week,1 and 3 month after CM therapy
Method of measurement
MOCA Paper Questionnaire: It is used to measure different levels of memory and the person must have at least 6 classes of literacy.
3
Description
Questionnaire ADL (Activities of Daily Living Scale) is a tool designed to measure the level of independence in ADLs in clinical outpatient populations
Timepoint
0 ,2 week,1 and 3 month after CM therapy
Method of measurement
Questionnaire ADL is paper-based and has 14 points.
Intervention groups
1
Description
Intervention group:: First, conditioned media solution or conditioned medium derived from mesenchymal stem cells from Wharton's jelly umbilical cord, 1 cc as an intranasal spray, twice a day (every 12 hours), for 3 consecutive days, produced in the hospital Motahari, Iran University of Medical Sciences
Category
Treatment - Drugs
2
Description
Intervention group: Second, CM, 2 cc as an intranasal spray, twice a day (every 12 hours), for 3 consecutive days,
Category
Treatment - Drugs
3
Description
Intervention group: Third, CM, 3 cc as an intranasal spray, twice a day (every 12 hours), for 3 consecutive days,
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Brain and Cognition Clinic (Firoozgar Hospital IUMS)
5th floor of the central headquarters, Research and Technology Vice President,Central Headquarters Building, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research.iums@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology, Iran University of Medical Sciences and Health Services
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
Iran University of Medical Sciences
Full name of responsible person
Naser Amini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Cellular and Molecular Research Center Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1636743943
Phone
+98 21 8670 4720
Email
amini.n@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naser Amini
Position
Assistant Professor of Neuroscience
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences, School of Advanced Technologies in Medicine, Cellular and Molecular Research Center
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4837
Email
amini.n@iums.ac.i
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Setareh Akbari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
No. 2, Qari Alley, Valiasr Alley, West Jhanbazan St
City
Tehran
Province
Tehran
Postal code
1636743943
Phone
+98 912 961 0488
Email
strhai632@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
.
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document