BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients

Phase 1

• Conditions: T2D
• Interventions: Biological: Intravenous Infusion of UC-MSC; Biological: Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC

• Registration Number: NCT04501341
• Lead Sponsor: Indonesia University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-03-14
• Study First Submitted: 2020-07-26
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-02
• Last Update Submitted: 2020-08-02
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC-MSC	Intravenous Infusion of UC-MSC	Umbilical cord mesenchymal stem cell
BM-MNC experimental	Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC	Autologue bone marrow mononuclear cell

Primary Outcome Measures

Name	Time	Method
Decreasing total daily dose of insulin (>= 30%)	Before intervention, 1st, 3rd, 6th, and 12th month after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Increasing of C-peptide level	Before intervention, 1st, 3rd, 6th, and 12th month after intervention	Measurements were obtained with mixed meal tolerance test
Immunology/inflammatory markers	Before intervention, 1st, 3rd, 6th, and 12th month after intervention	Measurements of Interleukin-10 and TNF-alfa from serum and supernatant from PBMC stimulation
HbA1c	Before intervention, 1st, 3rd, 6th, and 12th month after intervention	Stable HbA1c or decreasing HbA1c (from baseline)
Decreasing of insulin resistance level	Before intervention, 1st, 3rd, 6th, and 12th month after intervention	Measurement of HOMA-IR, calculated using fasting C-peptide and fasting plasma glucose formula
Adverse events	Up to 12 months after intervention	Thrombosis, hemorrhage, and infection

Trial Locations

Locations (1)

Faculty of Medicine, Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia