BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients

Indonesia University15 enrolled

Overview

The aim of this preliminary study is to evaluate the safety and efficacy of bone-marrow mononuclear cells (BM-MNCs) and umbilical-cord tissue-derived mesenchymal stem cells (UC-MSCs) administration in type 2 diabetes patients

Type 2 diabetes (T2D) patients had peripheral insulin resistance accompanied by progressive pancreatic beta cell degeneration and dysfunction due to glucotoxicity and lipotoxicity. Several studies have shown that the immune system plays a significant role in the pathogenesis of T2D. Bone-marrow mononuclear cells (BM-MNCs) and umbilical-cord tissue-derived mesenchymal stem cells (UC-MSCs) via its immunomodulatory properties have the potential to improve insulin resistance condition and pancreatic beta-cells dysfunction thus improve the glycemic control and insulin requirement in T2D patients. In this pilot study, we plan to recruit 15 T2D patients with total daily dose of insulin \>= 0.5 unit/kgBW/day to receive BM-MNCs (5 subjects) or UC-MSCs injections (10 subjects). These subjects will be closely followed up for 12 months for evaluation of primary and secondary outcome.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

T2D

Interventions

Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNCBIOLOGICAL

Autologous bone-marrow mononuclear cells infused to the main blood vessels that supply the pancreas according to the results of previous pancreatic CT-scan, performed by interventional radiologist. The target is to distribute the BM-MNCs equally in all part of the pancreas. Dosage: 1 x 10\^5 - 1 x 10\^6 CD34 cells/kgBW

Intravenous Infusion of UC-MSCBIOLOGICAL

Allogeneic umbilical cord tissue-derived mesenchymal stem cells will be given via intravenous infusion. Dosage: 2 x 10\^6 cells/kgBW, twice, with three months interval

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 \<= 8.5%) 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)

Locations (1)

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

RECRUITING

Outcomes

Primary Outcomes

Decreasing total daily dose of insulin (>= 30%)

After intervention, blood glucose level will be reported by the subjects on weekly basis. The insulin dose and/or oral medication will be adjusted accordingly.