Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
RSUP Dr. Sardjito Yogyakarta
No Registry
INA-6COKR1DA
Tanggal Input Registry : 24-06-2025

07-07-2025
adverse event
1. Serum creatinine, 2. Urinary albumin-creatinine ratio (UACR), 3. Glomerular filtration rate (GFR).
 
Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
Interventional
Allogeneic human umbilical cord mesenchymal stem cells (hUCMSCs). The study subjects received a single bilateral intra-renal artery hUCMSCs injection with CT guidance at a dose of 1x10^6 cells/kgBW.
10
 

Inclusion Criteria:

1. Type 2 DM 2. Age 40-65 years 3. Patients with clinical diagnosis of CKD stage III and IV (GFR 15-60 mL/min based on CKD-EPI) 4. Renal pathology examination with biopsy showing diagnosis of diabetic nephropathy type IIa – IV 5. Proteinuria with UACR from random urine sample (morning) 30-3000 mg/g at screening 6. Controlled DM, namely HbA1c

Exclusion Criteria:

1. Patients with malignancy or history of malignancy. 2. Patients with active liver disease or abnormal liver function tests (ALT or AST ≥2 times the upper limit of normal) 3. Hemoglobin
 
KE/FK/0264/EC/2025
Not applicable
Not applicable
Not Specified
Rima Haifa, S,Si., M.Farm-Klin