]>
IRCT201204248349N1 IRCT 2015-05-10 Presidency of the Islamic Republic of Iran, Vice-Presidency for Science and Technology Effects of mesenchymal stem cell therapy in patients with chronic kidney disease Evaluation of effects of injected autologous mesenchymal stem cells on kidney function in patients with chronic kidney disease 2014-01-30 anticipated 15 Complete https://irct.ir/trial/8826 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Chronic Kidney Disease (CKD). Intervention group: single peripheral injection of autologous mesenchymal stem cells (1,000,000/kg). The mesenchymal stem cells will be separated from bone marrow aspiration sample and then the cells will be cultured and proliferated in specialized lab until they reach enough numbers and then they will be injected through peripheral vein into the circulation. the injection will be performed only one time..
public Dr. Sudabeh Alatab
Urology Research Center, Sina Hospital, Hassan-Abad Sq. Emam Khomeini St. Tehran, Iran
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 sudabehalatab@yahoo.com Urology research Center, Sina Hospital scientific Dr. Iraj Najafi
4th Floor, Dr. Shariati hospital, North Kargar Ave. Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2469 najafi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: 1-CKD patient 2- GFR between 15-30 mml/min 3- No serious underlying disease 4- Availability of previous medical records for creatinin and GFR 5- Age between 18-65 years The necessary information will be given to patients before enrollment and patient will sign the consent form. Exclusion Criteria: 1- Serious mental disorders (suicide history, major depression) 2- Patients who cannot come for regular visits 3- Less than one year survival 4- Patients who use immunosuppressive drug 5- Pregnancy 6- Congestive Heart Failure (CHF) 7- Malignancy 8- Coagulation disorders 9- Uncontrolled hypertension 10- Positive virology tests 11- Infection or osteomyelitis in bone marrow aspiration site 12- Hb<8 g/dL, platelet <100,000 18 years 65 years Both N18.1, N18 Kidney damage with decreased GFR Treatment - Other Intervention group: single peripheral injection of autologous mesenchymal stem cells (1,000,000/kg). The mesenchymal stem cells will be separated from bone marrow aspiration sample and then the cells will be cultured and proliferated in specialized lab until they reach enough numbers and then they will be injected through peripheral vein into the circulation. the injection will be performed only one time. Blood pressure. Timepoint: Before and every two months after intervention up to one year. Method of measurement: Mercury sphygmomanometer. Serum creatinin. Timepoint: Baseline and every two months after intervention up to one year. Method of measurement: Autoanalyser. Glomerular filtration rate (GFR). Timepoint: Baseline and every two months after intervention up to one year. Method of measurement: MDRD formula. Urine creatinin. Timepoint: Baseline and every two months after intervention up to one year. Method of measurement: 24 h urine collection. Urine Protein. Timepoint: Baseline and every two months after intervention up to one year. Method of measurement: 24 h urine collection. Need to dialysis. Timepoint: Baseline and every two months after intervention. Method of measurement: Serum creatinin. Stem cell injection complications. Timepoint: Baseline and every two months after intervention. Method of measurement: Biochemical and clinical assessment of patients. Presidency of the Islamic Republic of Iran, Vice-Presidency for Science and Technology Approved 2012-02-22 Sciences Ethics committee of Tehran University Of Medical Sciences 6th floor, central building of TUMS, Ghods street, Keshavarz Blv, Tehran, Iran Tehran Iran (Islamic Republic of)