Chronic Kidney Failure in Children. N18.3Chronic kidney disease, stage 3Kidney damage with moderately decreased GFR (30-59 mL/min)N18.4Chronic kidney disease, stage 4Kidney damage with severely decreased GFR (15-29 mL/min)
Conditions
Interventions
Intervention group: Cell Type: Adipose-derived Mesenchymal Stem Cells (MSCs) of allogeneic origin. Cell Source: Adipose tissue from healthy donors. Administration Method: Systemic injection (intraveno
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: Age: 2-18 years Both genders (girls and boys) Evidence of chronic kidney damage with increased creatinine despite conventional treatments Chronic kidney failure defined as reduced kidney function with or without proteinuria for more than three months Patients with GFR 20-40 will be enrolled in the study Normal bone marrow function No use of immunosuppressive drugs for disease treatment Written informed consent (ethical consent form signed by parents) Able to comply with visit schedule and study procedures including follow-ups after hospital discharge
Exclusion criteria
Exclusion criteria: Suspected of any bacterial or viral infection Uncontrollable infection Recurrence or progression of disease caused by malignancy Specific contraindications for MSC injection Serious comorbidities that do not respond adequately to specific treatment Symptomatic brain metastases AKI due to post-renal outflow obstruction, glomerulonephritis, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA)-associated nephritis, anti-glomerular basement membrane disease, cryoglobulinemia, thrombotic microangiopathy, and AKI due to purpura nephritis Allergic individuals Organ transplant or hematopoietic stem cell transplant Patients with malignant tumors or those with a history of cancer Patients who are hemodynamically unstable Organ failure affecting more than 2 non-renal organs Acute or chronic vasculitis of any cause History of chronic systemic infection of any cause Immunosuppressive therapy that has not been stabilized for more than 4 months, or in the case of chronic corticosteroid treatment, doses exceeding 15 mg per day of prednisone or equivalent in the past 30 days Platelet count less than <25,000/uL or other severe hematological abnormalities that put the subject at risk of death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Outcome Variables: Acute and delayed adverse effects caused by the injection of allogeneic mesenchymal stem cells derived from adipose tissue in children aged 2 to 18 years with chronic kidney failure. Changes in vital signs (blood pressure, heart rate, respiration, and body temperature) after the injection of allogeneic mesenchymal stem cells derived from adipose tissue. Occurrence of acute and delayed allergic reactions in response to the injection of allogeneic mesenchymal stem cells derived from adipose tissue. Incidence of potential infections following the injection of allogeneic mesenchymal stem cells derived from adipose tissue Efficacy Outcome Variables: Changes in glomerular filtration rate (GFR) in children with chronic kidney failure after the injection of mesenchymal stem cells. Changes in blood pressure in children with chronic kidney failure after the injection of mesenchymal stem cells. Changes in residual urinary output in children with chronic kidney failure after the injection of mesenchymal stem cells. Changes in serum creatinine levels in children with chronic kidney failure after the injection of mesenchymal stem cells. Changes in proteinuria levels in children with chronic kidney failure after the injection of mesenchymal stem cells. Timepoint: Measurement of Safety and Efficacy Outcomes at Specific Time Points: Baseline (Before Starting the Intervention): To establish pre-treatment parameters. During Stem Cell Injection: To assess acute reactions. Week One Post-Injection: To evaluate immediate responses and complications. Month One Post-Injection: For monitoring short-term effects. Every Three Months During Follow-Up: To track long-term outcomes. At these time points, the following parameters will be measured and recorded: acute and delayed adverse effects, changes in vital signs, potential allergic reactions, potential infections, changes in GFR, blood pressure, residual urinary output, serum creatinine levels, and proteinuria levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Variables: Changes in Blood Biochemical Parameters Related to Kidney Function (Excluding Serum Creatinine, Which Is a Primary Outcome): Assessing additional biochemical markers to evaluate kidney functionality. Changes in Urine Test Parameters (Excluding Proteinuria, Which Is a Primary Outcome): Monitoring other urinary markers to assess kidney function and overall health. Improvement in Quality of Life of Children with Chronic Kidney Disease After Mesenchymal Stem Cell Therapy: Evaluated using standard quality-of-life assessment tools for pediatric patients. Changes in the Need for Routine Medications in Patients with Chronic Kidney Disease: Assessing any reduction or alteration in the dosage or dependency on medications. Changes in Growth and Development in Children After Mesenchymal Stem Cell Therapy: Evaluated using pediatric growth charts and developmental milestones. Each of these secondary outcome variables is aimed at assessing the efficacy of adipose-derived mesenchymal stem cell therapy in improving kidney function and the quality of life in children with chronic kidney disease. Timepoint: Baseline (Before Starting the Intervention): Serves as the initial measurement point. Week One Post-Stem Cell Injection: To assess early changes. Month One Post-Stem Cell Injection: For monitoring short-term effects. Every Three Months Post-Stem Cell Injection (Regularly During Follow-Up): To track long-term trends and sustained effects. These time points are designated for all secondary outcome variables, including: Changes in blood biochemical parameters related to kidney function Changes in urine test parameters Improvement in quality of life Changes in the need for routine medications Changes in growth and development in children This schedule is designed to allow for a thorough evaluation of the trends and changes in these variables over the entire study period. Method of measurement: Changes in Blood Biochemical Parameters Related to Kidney Functi | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMastaneh Moghtaderi
Tehran University of Medical Sciences
Outcome results
None listed