1. Home
  2. Approved trials
  3. » فارسی

Investigation on autologous mesenchymal stem cell transplantation in diabetic nephrophaty (type one)

Protocol summary

Summary
1-Objectives, Investigation on autologous mesenchymal stem cell transplantation in diabetic nephrophaty (type one) 2-Design, In the beginning, among patients with type one diabetes nephropathy who eligible for inclusion criteria and volunteer for cell therapy, twenty patients will be selected. 3-Setting and conduct, All stages of the project explain for each patients, then if they want to enter the project inform consent would be obtained from each patients. Then, from all participants asked to take SMBG for at least one month. After that each patients take laboratory samples for FBS and HbA1C at laboratory of Diabetes and Metabolic Diseases Clinic. Then, mesenchymal stem cells (MSCs) obtained via bone marrow aspiration would be cultured. Ater prepration of the cells, each patients receive MSCs by IV injection. One week before, a month later, three months, six, 12 and 24 months after cell treatment the patient will be examined and visited by medical team ,and according to the protocol follow up test will be done. 4- Participants including major eligibility criteria, Type 1 diabetic nephropathy with 30 ≤ GFR ≤ 45(mL/min/1.73 m2) 5- Intervention, Each patients receive 2 million MSCs / kg by IV injection. 6- main outcome measures (variables), Include Glomerular Filtration Rate (GFR) and Albumin/Creatinine ratio.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111291414N28
Registration date: 2012-07-29, 1391/05/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-29, 1391/05/08
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 (EMRI)
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-07-23, 1392/05/01
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 nephrophaty (type one)
Public title
Investigation on autologous mesenchymal stem cell transplantation in diabetic nephrophaty (type one)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. signing informed consent 2. People with diabetes type one with at least 10 years duration 3. age 18-40 years 4. Diabetic nephropathy diagnosed by nephrologists 5. HbA1c ≤ 7.5% (blood glucose is controlled at least for one month) Exclusion criteria: 1. acute vascular inflammation 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. Diastolic blood pressure ≥110 13. Cigar Smoker
Age
From 18 years old to 40 years old
Gender
Both
Phase
0
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
Ethics commttee of Tehran Medical University of Science
Street address
ShariatiHospital,North KargarSt,1411413137
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
E-00182

Health conditions studied

1

Description of health condition studied
Diabetes Nephropathy (type 1)
ICD-10 code
N08.3
ICD-10 code description
Glomerular disorders in diabetes mellitus

Primary outcomes

1

Description
GFR
Timepoint
Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion
Method of measurement
using MDRD and Cockroft-Gault formula-ml/min/1.73square meter

2

Description
Albumin/Creatinine ratio
Timepoint
Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion
Method of measurement
mg/mmol

Secondary outcomes

1

Description
C-peptide
Timepoint
Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion
Method of measurement
ng/ml

2

Description
Cr
Timepoint
Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion
Method of measurement
mg/dl

3

Description
BUN
Timepoint
Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion
Method of measurement
mg/dl

4

Description
HbA1c
Timepoint
Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion
Method of measurement
%

5

Description
FBS
Timepoint
Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion
Method of measurement
mg/dl

Intervention groups

1

Description
Injection of autologous mesenchymal stem cell
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes and metabolic diseases clinic
Full name of responsible person
Dr Nasli
Street address
Next to south entrance door of Tehran Heart Center,North KargarSt
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute (EMRI)
Full name of responsible person
Dr Ramin Heshmat
Street address
Shariati Hospital, North KargarSt, Endocrinology and Metabolism Research Institute (EMRI)
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute (EMRI)
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 and Metabolism Research Institute (EMRI)
Full name of responsible person
Dr Bagher Larijani
Position
Professor
Other areas of specialty/work
Street address
Shariati Hospital, North KargarSt, Endocrinology and Metabolism Research Institute (EMRI)
City
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Fax
+98 21 8822 0052
Email
emrc@tums.ac.ir
Web page address
http://emri.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Endocrinology and Metabolism Research Institute (EMRI)
Full name of responsible person
Maryam Ghodsi
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital, North KargarSt, Endocrinology and Metabolism Research Institute (EMRI)
City
Tehran
Postal code
1411413137
Phone
+98 21 8833 4192
Fax
+98 21 8800 3700
Email
emrc@tums.ac.ir
Web page address
http://emrc.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...