Protocol summary

Summary
In the beginning, among patients with type one diabetes who been diagnosed diabetic retinopathy and volunteers for cell therapy, twenty patients will be selected. 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 EMRI. Then, mesenchymal stem cells obtained via bone marrow aspiration would be cultured. Each patients receive 2 millionmesenchymal stem cell per kilogram by IV injection. Optic Coherence Tomography(OCT), retinal artery flow (by Angiography fluorescein) and visual acuity according to the chart Snellen will be examined in our patient at regular interval : One week before, a month later, two months, six and nine months after cell treatment and visited by medical team ,and according to the protocol follow up test will be done. Expecting by both development of these cells into retinal cells and regulation of immune system (which has an important role in the improvement of diabetes) lead to improve function of eyes in patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111291414N29
Registration date: 2012-08-14, 1391/05/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-14, 1391/05/24
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 of 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
Scientific title
Investigation on autologous mesenchymal stem cell transplantation in diabetic retinopathy
Public title
Investigation on autologous mesenchymal stem cell transplantation in diabetic retinopathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:People with diabetes type one with at least 10 years duration ;Age 18-40 years;Signing informed consent;Patients with diabetic retinopathy diagnosed by an ophthalmologist ;HbA1c ≤ 7.5% (blood glucose is controlled at least for one month);All eligible patients for celltherapy (according to standard protocol ); BP≤130/80 ;Cardiac Consultation form that is filled by a cardiologist (Cardiac echocardiography and ECG) Exclusion criteria: Acute vascular inflammation ; Acute thrombosis (three months); Pulmonary hypertension;Liver disease; Hematological malignancy and bone marrow cancer;Infectious diseases;Mental illness; Generalized edema ; Malignancy; pregnancy ; Sensitivity to the fluorescein
Age
From 18 years old to 40 years old
Gender
Both
Phase
0
Groups that have been masked
None
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
This is an interventional study to evaluate the effect autologous transplant of bone marrow stem cells for patients with diabetes type one.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Endocrine & Metabolism Research Institute Tehran University Of Medical Sciences
Street address
ShariatiHospital,North KargarSt
City
Tehran
Country
Iran (Islamic Republic of)
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 retinopathy (dibetes type one)
ICD-10 code
H36.0*
ICD-10 code description
Diabetic retinopathy

Primary outcomes

1

Description
Retin blood Flow
Timepoint
Optic Coherence Tomography(OCT), retinal artery flow (by Angiography fluorescence) and visual acuity according to the chart Snellen will be examined in our patient at regular interval : One week before, a month later, two months, six and nine months after cell treatment and visited by medical team ,and according to the protocol follow up test will be done.
Method of measurement
Fluorescein Angiography

Secondary outcomes

1

Description
Optic Coherence
Timepoint
One week before, one, two, six and nine months after intervention
Method of measurement
Optic Coherence Tomgtaphy

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
Full name of responsible person
Dr. Nasli- Dr.Razmandeh
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue
City
Tehran
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The EMRI Endocrinology and 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
City
Tehran
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The EMRI Endocrinology and 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
Professor
Full name of responsible person
Dr. Larijani
Position
Endocrinology & Metabolism Research Center, Dr.Shariati Hospital
Other areas of specialty/work
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1411413137
Phone
+98 21 8822 0037
Fax
+98 21 8822 0052
Email
emrc@tums.ac.ir
Web page address
http://emrc.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The EMRI Endocrinology and Metabolism Research Institute , Tehran University of Medical Sciences
Full name of responsible person
Dr. Nasli ,Dr.Razmandeh
Position
Assistant professor, General Practitioner
Other areas of specialty/work
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1411413137
Phone
+98 21882200378
Fax
+98 21 8822 0052
Email
r.razmandeh1388@gmail.com
Web page address
http://emri.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
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