BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients

University of Indonesia (UI)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: T2D

Treatments: Biological: Intravenous Infusion of UC-MSC; Biological: Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC

Study type: Interventional

Funder types: Other

Identifiers

NCT04501341

132/PT02.FK25/U.Eu113/METEND/V

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

BM-MNC experimental

Experimental group

Description:

Autologue bone marrow mononuclear cell

Treatment:

Biological: Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC

UC-MSC

Experimental group

Description:

Umbilical cord mesenchymal stem cell

Treatment:

Biological: Intravenous Infusion of UC-MSC