Clinical trial NCT04501341: BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients
Official title: Effectivity and Safety of Autologous BM-MNC Stem Cell Therapy and Allogenic Umbilical Cord Mesenchymal Stem Cell for Type 2 Diabetes Mellitus Patients"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: T2D
Keywords: type 2 diabetes
Bone-marrow mononuclear cells
Umbilical cord mesenchymal stem cells
Glycemic control
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Dr Cipto Mangunkusumo General Hospital
First posted: 2020-08-06
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 5 subjects receive BM-MNC and 10 subjects receive UC-MSC
Primary purpose: TREATMENT

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.

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 \<= 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)

Primary outcomes:
measure: Decreasing total daily dose of insulin (>= 30%)
timeFrame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
Secondary outcomes:
measure: Increasing of C-peptide level
timeFrame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
measure: Decreasing of insulin resistance level
timeFrame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
measure: Immunology/inflammatory markers
timeFrame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
measure: Adverse events
timeFrame: Up to 12 months after intervention
measure: HbA1c
timeFrame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
state: DKI Jakarta
Study officials:
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