BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients
Tahapan Penelitian : Recruit
Sponsor:
PT Prodia StemCell Indonesia
Mitra Pelaksana:
Dr. Cipto Mangunkusumo National General Hospital
No Registry
Tanggal Input Registry : 04-06-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 24-09-2024 |
| Outcome Primer | Decreasing total daily dose of insulin (>= 30%) |
| Outcome Skunder | Increasing of C-peptide level |
| Descriptive Information | |
| Judul Penelitian Popular | BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients |
| Judul Penelitian Ilmiah | Effectivity and Safety of Autologous BM-MNC Stem Cell Therapy and Allogenic Umbilical Cord Mesenchymal Stem Cell for Type 2 Diabetes Mellitus Patients |
| Jenis Penelitian | Interventional |
| Intervensi | Experimental: Autologue bone marrow mononuclear cell Experimental: Umbilical cord mesenchymal stem cell |
| Jumlah Subyek Penelitian | 10 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Type 2 diabetes patients on insulin therapy with or without oral hypoglycemic agents with total daily dose of insulin >= 0,5 unit/kg body weight, Stable HbA1C in the last six months (HbA1cExclusion Criteria: Type 1 diabetes mellitus, eGFR < 45 mL/min/m2 (for BM-MNC), Liver disease (moderate- severe), Active infection, Contrast hypersensitivity (for BM-MNC), History of Malignancy, Acute coronary syndrome in last three months, Coronary arterial diseases with significant stenosis and has not carried out revascularization, Pregnancy (for women subjects) |
| Administrative Information | |
| Nomor Persetujuan Etik | 206/UN2.F1/ETIK/2016 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | dr. Farid Kurniawan, Sp.PD, PhD |