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T2DPhase 1/2NCT04501341

BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients

A Phase 1/2 study testing Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC and Intravenous Infusion of UC-MSC in people with T2D, run by Universitas Indonesia at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
T2D
What is being tested?
Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC and Intravenous Infusion of UC-MSC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteIndonesia
Study dates
14 Mar 2016to 1 Dec 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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
Show all 9Show fewer
  • Acute coronary syndrome in last three months
  • Coronary arterial diseases with significant stenosis and has not carried out revascularization
  • Pregnancy (for women subjects)

Trial locations and contacts

1 site in 1 country.

Indonesia1 site, 1 recruiting

  • Faculty of Medicine, Universitas Indonesia

    Jakarta Pusat, DKI Jakarta, 10430

    Pradana Soewondo, Prof, +628188160756, pradana.soewondo@ui.ac.id

    Recruiting

Other trials in Indonesia

About this study

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"

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

Read the 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.

Conditions
T2D
Being tested
Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC, Intravenous Infusion of UC-MSC
Keywords
type 2 diabetes, Bone-marrow mononuclear cells, Umbilical cord mesenchymal stem cells, Glycemic control
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNCBiological

    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

  • Intravenous Infusion of UC-MSCBiological

    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

Study groups in NCT04501341
Study groupRoleWhat they receive
BM-MNC experimentalExperimentalAutologue bone marrow mononuclear cell
Receives: Biological: Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC
UC-MSCExperimentalUmbilical cord mesenchymal stem cell
Receives: Biological: Intravenous Infusion of UC-MSC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. Increasing of C-peptide level

    Measurements were obtained with mixed meal tolerance test

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

  2. Decreasing of insulin resistance level

    Measurement of HOMA-IR, calculated using fasting C-peptide and fasting plasma glucose formula

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

  3. Immunology/inflammatory markers

    Measurements of Interleukin-10 and TNF-alfa from serum and supernatant from PBMC stimulation

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

  4. Adverse events

    Thrombosis, hemorrhage, and infection

    Measured: Up to 12 months after intervention

  5. HbA1c

    Stable HbA1c or decreasing HbA1c (from baseline)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start14 Mar 2016
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion1 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
5 subjects receive BM-MNC and 10 subjects receive UC-MSC
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04501341
Sponsor's protocol ID
132/PT02.FK25/U.Eu113/METEND/V
Status last verified
Aug 2020
First submitted
26 Jul 2020
Last updated
6 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24457898

  • 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.

    PubMed 25999531

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

    PubMed 19817513

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

    PubMed 16035295

  • 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.

    PubMed 28066789

  • 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.

    PubMed 26136869

  • 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.

    PubMed 19364067

  • 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.

    PubMed 23561959

  • 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.

    PubMed 22814142

  • 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.

    PubMed 23093863

  • 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.

    PubMed 31214172

  • 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.

    PubMed 26794657

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC and Intravenous Infusion of UC-MSC in people with T2D, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decreasing total daily dose of insulin (>= 30%) (time frame: Before intervention, 1st, 3rd, 6th, and 12th month after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04501341, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.

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