main goal is to access the safety of treatment with placental mesenchymal stem cell in new onset T1DM patients.
Design
10 eligible new onset T1DM patients with 12-18 yr age will be enrolled in this phase one clinical trial. no blinding and single group clinical trial will be done and placental mesenchymal stem cell will be transplanted with clinical grade standard .
Settings and conduct
new onset T1DM patients with less than 6 month from Diagnosis will be enrolled. intravenous injection of clinical grade placental mesenchymal stem cell-which cultured in endocrinology and metabolism research institute- will be done after taken inform consent from patients in children medical center . before and after placental mesenchymal stem cell transplantation we will check laboratory parameter of diabetes mellitus, insulin consumption, and adverse events and visit the patients in intervals before and after transplantation for 1 year.
Participants/Inclusion and exclusion criteria
inclusion criteria
both gender
12-18 years old
type one diabetes mellitus
at least one positive auto antibody of T1DM
in first 6 month of diagnosis
Exclusion criteria
malignancy
simultaneous auto immune disorders
pregnancy
DKA presentation
chronic disorder
Intervention groups
transplantation of placental mesenchymal stem cell from peripheral vein and with dose 2 million per new onset diabetic patient kilogram weight
Main outcome variables
HbA1c level; c-peptide level; T1DM auto antibodies; FBS and PPG; insulin requirment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171021036903N2
Registration date:2019-12-24, 1398/10/03
Registration timing:registered_while_recruiting
Last update:2019-12-24, 1398/10/03
Update count:0
Registration date
2019-12-24, 1398/10/03
Registrant information
Name
sedigheh madani
Name of organization / entity
EMRI
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 1298
Email address
s_madani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
phase I clinical trial placental mesenchymal stem cell therapy for the treatment of type 1 diabetes mellitus
Public title
The safety of placental mesenchymal stem cell therapy for the treatment of type 1 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
both gender
12-18 years old
type one diabetes mellitus
at least one positive auto antibody of T1DM
in first 6 month of diagnosis
Exclusion criteria:
malignancy
simultaneous auto immune disorders
pregnancy
chronic disorder other than diabetes
Age
From 12 years old to 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
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 tehran university of medical science
Street address
Bolvar keshavarz street, Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4367
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus type 1
ICD-10 code
E10.9
ICD-10 code description
Type 1 diabetes mellitus without complications
Primary outcomes
1
Description
daily insulin requirement
Timepoint
Before intervention and 1,3,6,12 month after intervention
Method of measurement
daily insulin requirement per kilogram weight
2
Description
HbA1c
Timepoint
Before and 1,3,6,12 month after intervention
Method of measurement
blood sample
3
Description
c peptide level
Timepoint
Before and 1,3,6,12 month after intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
life threatening major side effect
Timepoint
before and 1,3,6 ,12 months after intervention
Method of measurement
physical examination
Intervention groups
1
Description
one time placental mesenchymal stem cell transplantation -which produced in endocrinology and metabolism research institute of Tehran university of medical science- from peripheral vein to T1Dm patients with 2 million per kilogram weight dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
TUMS hospitals-Endocrinology and metabolism research institute
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
from clinical scientist budget
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
Seyyedeh Sedigheh Madani
Position
Pediatric Endocrinology Subspecialist, Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Jalal Al Ahmed
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Fax
+98 21 8822 0052
Email
sedigheh_madani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyyedeh Sedigheh madani
Position
pediatric endocrinologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Jalal al Ahmed
City
tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Email
sedigheh_madani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
seyyedeh sedigheh madani
Position
pediatric endocrinology subspecialist student
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
jalal al ahmed
City
tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Email
sedigheh_madani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
donor and recipient demographic data and recipient fallow up data
When the data will become available and for how long
from beginning to the end of the study
To whom data/document is available
principal manager /the supervisor professor /ethic committee
Under which criteria data/document could be used
for analysis of the results and searching the reason of the probable side effects
From where data/document is obtainable
PI
What processes are involved for a request to access data/document
PI acceptance ------ ethic committee acceptance ------- recording of this acceptance and the amount of data that should be given and the result that should be achieved