In this study we aim to examine the effect of mesenchymal stem cell transplantation on treatment of type 1 diabetic patients. Clinical trial is performed on 20 type 1 diabetic patients aged 5 to 30 years who are in stages before the onset of severe irreversible complications ,have FBS level less than 200 mg/dl and have diabetes for up to 20 weeks. Patients who have history of DKA presentations or have acute infectious diseases are excluded from the trial. Adult human MSCs are isolated from the healthy bone marrow of patients and cultured. Patients receive 2 injections with the interval of 3 months and dose of 2 million MSCs/kg. Before and 3, 6, 12 months after the first injection the clinical and paraclinical indexes of patients are assessed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810271414N8
Registration date:2010-04-06, 1389/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-06, 1389/01/17
Registrant information
Name
Bagher Larijani
Name of organization / entity
Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
emrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology & Metabolism Research Center, Dr.Shariati hospital
Expected recruitment start date
2010-01-15, 1388/10/25
Expected recruitment end date
2010-03-16, 1388/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Autologous mesenchymal stem cell transplantation in the treatment of type 1 diabetic patients
Public title
Mesenchymal stem cell transplantation in the treatment of type 1 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: signing informed consent, presence of type 1 diabetes, age 5-30 years, duration of diabetes up to 20 weeks, being in stages before the onset of severe irreversible complications
Exclusion criteria: history of DKA presentation, having acute infectious diseases
Age
From 5 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Endocrinology & Metabolism Research Center, Dr.Shariat hospitali
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue, Tehran, Iran
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
E-0069
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
CD markers
Timepoint
3 months
Method of measurement
serum analysis
2
Description
anti insulin Ab
Timepoint
3 months
Method of measurement
serum analysis
3
Description
anti receptor Ab
Timepoint
3 months
Method of measurement
serum analysis
4
Description
anti GAD
Timepoint
3 months
Method of measurement
serum analysis
5
Description
c-peptide
Timepoint
3 months
Method of measurement
serum analysis
6
Description
HbA1c
Timepoint
3 months
Method of measurement
blood sample analysis
7
Description
insulin dose
Timepoint
3 months
Method of measurement
mean dose of insulin injected in one week
8
Description
mean of FBS
Timepoint
3 months
Method of measurement
blood sample
9
Description
mean of BS
Timepoint
3 months
Method of measurement
blood sample
Secondary outcomes
empty
Intervention groups
1
Description
autologous mesenchymal stem cell transplantation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ٍٍٍEndocrinology & Metabolism Research Center, Dr.Shariati hospital
Full name of responsible person
Dr. Nasli - Dr.Mojahed - Dr. Amini
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrinology & Metabolism Research Center
Full name of responsible person
Dr. Larijani
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology & Metabolism Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrinology & Metabolism Research Center, Dr.Shariati Hospital
Full name of responsible person
Dr. Larijani
Position
Professor
Other areas of specialty/work
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8822 0037
Fax
Email
emrc@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Endocrinology & Metabolism Research Center, Dr.Shariati Hospital
Full name of responsible person
Dr. Nasli
Position
Assistant professor
Other areas of specialty/work
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21882200378
Fax
+98 21 8822 0052
Email
n.nasli@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)