The goal of our study is to assess the immunity and feasibility of using bone marrow stem cells for treatment of renal failure. The most important inclusion criterion is presence of stage III diabetic nephropathy (GFR between 30 to 60 ml / min /1.73 m2) and the main exclusion criterion is presence of renal artery stenosis. We select 10 patients of Labafi Nejad Hospital suffering from renal failure secondary to diabetes mellitus and after receiving their written consents, take stem cell sample. Subsequently, mesenchymal stem cells will be separated after being cultured and will be injected back into the patient’s peripheral vein. Patients will be followed up regarding kidney function through laboratory tests (BUN and Creatinine) and possible complications for a period of one year.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804091267N19
Registration date:2009-07-14, 1388/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-07-14, 1388/04/23
Registrant information
Name
Mojgan Borgheie
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University of Mediacal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
research@unrc.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R. Iran
Expected recruitment start date
2008-09-02, 1387/06/12
Expected recruitment end date
2010-09-03, 1389/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A phase I clinical trial on the use of autograft mesenchymal stem cells for treatment of diabetic chronic kidney disease
Public title
A phase I clinical trial on the use of autograft mesenchymal stem cells for treatment of diabetic chronic kidney disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of stage III diabetic nephropathy (GFR between 30 to 60 ml / min /1.73 m2), controlled hypertension, Blood creatinine level less than 2 mg/dl
Exclusion criteria: History or presence of psychological disorders, history or presence of previous immune deficiencies, consumption of immunosuppressive drugs, presence of renal artery stenosis
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.