Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
Tahapan Penelitian : Recruit
Sponsor:
PT Prodia StemCell Indonesia
Mitra Pelaksana:
RSUP Dr. Sardjito Yogyakarta
No Registry
INA-6COKR1DA
Tanggal Input Registry : 24-06-2025
Tracking Information | |
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Tanggal Antisipasi Studi | 07-07-2025 |
Outcome Primer | adverse event |
Outcome Skunder | 1. Serum creatinine, 2. Urinary albumin-creatinine ratio (UACR), 3. Glomerular filtration rate (GFR). |
Descriptive Information | |
Judul Penelitian Popular | Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial |
Judul Penelitian Ilmiah | Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial |
Jenis Penelitian | Interventional |
Intervensi | 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. |
Jumlah Subyek Penelitian | 10 |
Recruitment Information | |
Eligibility Criteria | 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 HbA1cExclusion 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 |
Administrative Information | |
Nomor Persetujuan Etik | KE/FK/0264/EC/2025 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
Other Study ID Numbers | Not Specified |
Contact Person | Rima Haifa, S,Si., M.Farm-Klin |