Chronic Kidney Disease (CKD). Kidney damage with decreased GFR
Conditions
Interventions
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
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
Sponsors
Presidency of the Islamic Republic of Iran, Vice-Presidency for Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Sudabeh Alatab
Urology research Center, Sina Hospital
Outcome results
None listed