In the first through volunteers patients with diabetes type 1 ,that they have diabetic neuropathy and to take the similar medication in the two groups control and case consisted of twenty patients in each group will be selected. The plan is explained for all patients after if they want to be entered in study they have to sign consent. Then the patient is asked to monitor their blood glucose for one month (Self Monitoring Blood Glocose) should be to control their diabetes. After each patient are sampled to measure fasting blood glucose and HbA1C in Laboratory of Diabetes Centerpy. Adult human MSCs are isolated from the healthy bone marrow of patients of case group and cultured. Patients receive 1 injection dose of 2 million MSCs/kg. patients.Both of two groups one week before cell therapy and 1.5 ,3 , 6,12 and months after cell therapy will be examined by the medical team that includes physicians, endocrinology and neurological .Michigan survey, UK, a ten-point test monofilament test , diapason ,,( VASVisual Analog Scale) test and EMG NCV will be performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103171414N23
Registration date:2012-07-10, 1391/04/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-10, 1391/04/20
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 and Metabolism Research Institute Tehran University Of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on autologous mesenchymal stem cell transplantation in diabetic neurophaty
Public title
Effect of mesenchymal stem cells transplantation to improve of diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-People with diabetes type one that their disease passed at least 10 years 2-signing informed consent, 3-age 40-60 years4- All patients are eligible for cell therapy (under protocol) 5 - HbA1c ≤ 7.5% (blood glucose is controlled at least of one month) 6 - BP ≤ 130/80Exclusion criteria: 1 - acute inflammation of vascular 2 - acute thrombosis (three months) 3 - recent bleeding in the retina (the last three months) 4 - pulmonary hypertension 5 - liver disease 6- tumors in bone marrow or any malignancy is diagnosed 7 - infectious diseases 8-mental illness 9- generalized edema 10 - malignancy 11 - pregnancy 12 - to use any walking aids 13 - having a foot ulcer during the study 14 - amputation of limbs
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Tehran University Of Medical Sciences
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue,
City
Tehran
Postal code
1411413137
Approval date
2011-12-28, 1390/10/07
Ethics committee reference number
E-00182
Health conditions studied
1
Description of health condition studied
Diabetic neurophaty
ICD-10 code
G63.2*
ICD-10 code description
Diabetic polyneuropathy (E10-E14 with common fourth character .4+)
Primary outcomes
1
Description
Monofilament test
Timepoint
Before intervention and 6,12,24,48,96 weeks after intervention
Method of measurement
Numeration
2
Description
Diapason test
Timepoint
Before intervention and 6,12,24,48,96 weeks after intervention
Method of measurement
Numeration
3
Description
Electromyography & Nnerve conduction velocity
Timepoint
Before intervention and 6,12,24,48,96 weeks after intervention
Method of measurement
mV
4
Description
Visual Analog Scale
Timepoint
Before intervention and 6,12,24,48,96 weeks after intervention
Method of measurement
numerical
Secondary outcomes
1
Description
Weight
Timepoint
Before intervention and 4,12,24,48,96 weeks after intervention
Method of measurement
Weigher
2
Description
Fasting blood glucose
Timepoint
Before intervention and 4,12,24,48,96 weeks after intervention
Method of measurement
Glucose oxidase
3
Description
HbA1c
Timepoint
Before intervention and 4,12,24,48,96 weeks after intervention
Method of measurement
HPLC
Intervention groups
1
Description
Once Injection 2 million cells per kilogram of body weight of autologous mesenchymal stem cells were taken from the bone marrow amount of 50 ml during 30 minutes for one time.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Institute Tehran University Of Medical Sciences
Full name of responsible person
Dr.ٍEnsieh Nasli
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Institute Tehran University Of Medical Sciences
Full name of responsible person
Dr. Nika Mojahed
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ٍٍٍEndocrinology & Metabolism Research Institute Tehran University Of Medical Sciences
Full name of responsible person
Dr. Ramin Heshmat
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 Institute Tehran University Of Medical Sciences
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 InstituteTehran University Of Medical Sciences
Full name of responsible person
Dr. Bagher Larijani
Position
Professor
Other areas of specialty/work
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue, Tehran, Iran
City
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Fax
+98 21 8822 0052
Email
emrc@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ٍٍٍEndocrinology & Metabolism Research InstituteTehran University Of Medical Sciences
Full name of responsible person
Dr. Ensieh 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
1411413137
Phone
+98 21 8490 2677
Fax
+98 21 8822 0052
Email
emrc@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)