BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients

August 2, 2020 updated by: Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD, Indonesia University

Effectivity and Safety of Autologous BM-MNC Stem Cell Therapy and Allogenic Umbilical Cord Mesenchymal Stem Cell for Type 2 Diabetes Mellitus Patients"

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Faculty of Medicine, Universitas Indonesia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BM-MNC experimental
Autologue bone marrow mononuclear cell
Biological: Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC
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
Experimental: UC-MSC
Umbilical cord mesenchymal stem cell
Biological: Intravenous Infusion of UC-MSC
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreasing total daily dose of insulin (>= 30%)
Time Frame: 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.
Before intervention, 1st, 3rd, 6th, and 12th month after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

Dr Cipto Mangunkusumo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 26, 2020

First Submitted That Met QC Criteria

August 2, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 2, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132/PT02.FK25/U.Eu113/METEND/V

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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