BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients

NCT04501341 | Unknown Phase 1 DMC

• 1 other identifier: 132/PT02.FK25/U.Eu113/METEND/V
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

T2D

Keywords

type 2 diabetes; Bone-marrow mononuclear cells; Umbilical cord mesenchymal stem cells; Glycemic control

Outcome Measures

Primary Outcomes (1)

• 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.

  Before intervention, 1st, 3rd, 6th, and 12th month after intervention

Secondary Outcomes (5)

• Increasing of C-peptide level

  Before intervention, 1st, 3rd, 6th, and 12th month after intervention

• Decreasing of insulin resistance level

  Before intervention, 1st, 3rd, 6th, and 12th month after intervention

• Immunology/inflammatory markers

  Before intervention, 1st, 3rd, 6th, and 12th month after intervention

• Adverse events

  Up to 12 months after intervention

• HbA1c

  Before intervention, 1st, 3rd, 6th, and 12th month after intervention

Study Arms (2)

BM-MNC experimental

EXPERIMENTAL

Autologue bone marrow mononuclear cell

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

UC-MSC

EXPERIMENTAL

Umbilical cord mesenchymal stem cell

Biological: Intravenous Infusion of UC-MSC

Interventions

Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC BIOLOGICAL

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

BM-MNC experimental

Intravenous Infusion of UC-MSC BIOLOGICAL

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

UC-MSC

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indonesia University: lead
• Dr Cipto Mangunkusumo General Hospital: collaborator

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Related Publications (12)

• Itariu BK, Stulnig TM. Autoimmune aspects of type 2 diabetes mellitus - a mini-review. Gerontology. 2014;60(3):189-96. doi: 10.1159/000356747. Epub 2014 Jan 22.

  PMID: 24457898 BACKGROUND

• Tsai S, Clemente-Casares X, Revelo XS, Winer S, Winer DA. Are obesity-related insulin resistance and type 2 diabetes autoimmune diseases? Diabetes. 2015 Jun;64(6):1886-97. doi: 10.2337/db14-1488.

  PMID: 25999531 BACKGROUND

• Campbell RK, Martin TM. The chronic burden of diabetes. Am J Manag Care. 2009 Sep;15(9 Suppl):S248-54.

  PMID: 19817513 BACKGROUND

• Fery F, Paquot N. [Etiopathogenesis and pathophysiology of type 2 diabetes]. Rev Med Liege. 2005 May-Jun;60(5-6):361-8. French.

  PMID: 16035295 BACKGROUND

• Wehbe T, Chahine NA, Sissi S, Abou-Joaude I, Chalhoub L. Bone marrow derived stem cell therapy for type 2 diabetes mellitus. Stem Cell Investig. 2016 Dec 6;3:87. doi: 10.21037/sci.2016.11.14. eCollection 2016.

  PMID: 28066789 BACKGROUND

• Guan LX, Guan H, Li HB, Ren CA, Liu L, Chu JJ, Dai LJ. Therapeutic efficacy of umbilical cord-derived mesenchymal stem cells in patients with type 2 diabetes. Exp Ther Med. 2015 May;9(5):1623-1630. doi: 10.3892/etm.2015.2339. Epub 2015 Mar 9.

  PMID: 26136869 BACKGROUND

• Estrada EJ, Valacchi F, Nicora E, Brieva S, Esteve C, Echevarria L, Froud T, Bernetti K, Cayetano SM, Velazquez O, Alejandro R, Ricordi C. Combined treatment of intrapancreatic autologous bone marrow stem cells and hyperbaric oxygen in type 2 diabetes mellitus. Cell Transplant. 2008;17(12):1295-304. doi: 10.3727/096368908787648119.

  PMID: 19364067 BACKGROUND

• Bhansali A, Asokumar P, Walia R, Bhansali S, Gupta V, Jain A, Sachdeva N, Sharma RR, Marwaha N, Khandelwal N. Efficacy and safety of autologous bone marrow-derived stem cell transplantation in patients with type 2 diabetes mellitus: a randomized placebo-controlled study. Cell Transplant. 2014;23(9):1075-85. doi: 10.3727/096368913X665576.

  PMID: 23561959 BACKGROUND

• Hu J, Li C, Wang L, Zhang X, Zhang M, Gao H, Yu X, Wang F, Zhao W, Yan S, Wang Y. Long term effects of the implantation of autologous bone marrow mononuclear cells for type 2 diabetes mellitus. Endocr J. 2012;59(11):1031-9. doi: 10.1507/endocrj.ej12-0092. Epub 2012 Jul 13.

  PMID: 22814142 BACKGROUND

• Chao YH, Wu HP, Chan CK, Tsai C, Peng CT, Wu KH. Umbilical cord-derived mesenchymal stem cells for hematopoietic stem cell transplantation. J Biomed Biotechnol. 2012;2012:759503. doi: 10.1155/2012/759503. Epub 2012 Oct 3.

  PMID: 23093863 BACKGROUND

• Weiss ARR, Dahlke MH. Immunomodulation by Mesenchymal Stem Cells (MSCs): Mechanisms of Action of Living, Apoptotic, and Dead MSCs. Front Immunol. 2019 Jun 4;10:1191. doi: 10.3389/fimmu.2019.01191. eCollection 2019.

  PMID: 31214172 RESULT

• Gao F, Chiu SM, Motan DA, Zhang Z, Chen L, Ji HL, Tse HF, Fu QL, Lian Q. Mesenchymal stem cells and immunomodulation: current status and future prospects. Cell Death Dis. 2016 Jan 21;7(1):e2062. doi: 10.1038/cddis.2015.327.

  PMID: 26794657 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: 5 subjects receive BM-MNC and 10 subjects receive UC-MSC

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: August 6, 2020
• Study Start: March 14, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

ID (1)