BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients

Tahapan Penelitian : Recruit

Sponsor:

Mitra Pelaksana:

Dr. Cipto Mangunkusumo National General Hospital

No Registry

INA-0WBK8H7N

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 (HbA1c Exclusion 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