A Phase 1/2 interventional study of Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC and Intravenous Infusion of UC-MSC in T2D, sponsored by Indonesia University. Status unknown at 1 site in Indonesia. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-08-06.
Sponsored by Indonesia University · Phase 1/2, Interventional, and Treatment
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 15 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Autologue bone marrow mononuclear cell
Biological: Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC
Umbilical cord mesenchymal stem cell
Biological: Intravenous Infusion of UC-MSC
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
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
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.
Time frame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
Increasing of C-peptide level
Measurements were obtained with mixed meal tolerance test
Time frame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
Decreasing of insulin resistance level
Measurement of HOMA-IR, calculated using fasting C-peptide and fasting plasma glucose formula
Time frame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
Immunology/inflammatory markers
Measurements of Interleukin-10 and TNF-alfa from serum and supernatant from PBMC stimulation
Time frame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
Adverse events
Thrombosis, hemorrhage, and infection
Time frame: Up to 12 months after intervention
HbA1c
Stable HbA1c or decreasing HbA1c (from baseline)
Time frame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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