Diabetes MellitusPhase 1/2NCT05207995

The Treatment of Patients With Type 1 Diabetes Mellitus With Autologous Tolerogenic Dendritic Cells

A Phase 1/2 study testing Autologous tolerogenic dendritic cells and Standard treatment according to the clinical protocols in people with Diabetes Mellitus, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the safety and tolerability of the administration of tolerogenic dendritic cells in patients with type 1 diabetes mellitus. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Autologous tolerogenic dendritic cells and Standard treatment according to the clinical protocols
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteBelarus
Study dates: 1 Mar 2022to 26 Dec 2023
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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Clinical diagnosis of Type 1 Diabetes Mellitus
The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
Written informed consent

Who cannot join

The presence of any malignant tumor within the last 5 years
Acute or chronic diseases in the stage of decompensation
Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
Patients are unable or unwilling to give written informed consent and / or follow research procedures
Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Trial locations and contacts

1 site in 1 country.

Belarus1 site

Healthcare institution "Minsk City Clinical Endocrinology Center"
Minsk, 220000

Other trials in Belarus

About this study

Official title: A Phase ½ Study to Evaluate the Safety and Feasibility of Autologous Tolerogenic Dendritic Cells in Patients With Type 1 Diabetes Mellitus

The purpose of this study is to determine the safety and tolerability of the administration of tolerogenic dendritic cells in patients with type 1 diabetes mellitus.

Read the detailed description

The purpose of this study is to determine the safety and tolerability of the administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides in patients with type 1 diabetes mellitus.

Conditions: Diabetes Mellitus
Being tested: Autologous tolerogenic dendritic cells, Standard treatment according to the clinical protocols
Medical subject headings: Diabetes Mellitus

What participants receive

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

Autologous tolerogenic dendritic cellsBiological
Autologous tolerogenic dendritic cells treated with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides (MSC-tolDC) injected subcutaneous.
Standard treatment according to the clinical protocolsOther
Standard treatment of type 1 diabetes mellitus according to the clinical protocols

Study groups in NCT05207995
Study group	Role	What they receive
Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells	Experimental	Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells Receives: Biological: Autologous tolerogenic dendritic cells; Other: Standard treatment according to the clinical protocols
Patients with Type 1 Diabetes Mellitus receiving standard treatment	Active comparator	Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment Receives: Other: Standard treatment according to the clinical protocols

What is being measured

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

The glucose concentration in blood
To assess the glucose concentration in blood
Measured: 1 month
The glycated hemoglobin concentration
To assess the β-cell function measured by the glycated hemoglobin in blood
Measured: 1 month
The C-peptide level in blood
To assess the β-cell function measured by the C-peptide level
Measured: 1 month
The glucose concentration in blood
To assess the glucose concentration in blood
Measured: 6 months
The glycated hemoglobin concentration
To assess the β-cell function measured by the glycated hemoglobin in blood
Measured: 6 months
The C-peptide level in blood
To assess the β-cell function measured by the C-peptide level
Measured: 6 months
The glucose concentration in blood
To assess the glucose concentration in blood
Measured: 1 year
The glycated hemoglobin concentration
To assess the β-cell function measured by the glycated hemoglobin in blood
Measured: 1 year
The C-peptide level in blood
To assess the β-cell function measured by the C-peptide level
Measured: 1 year
Autoantigen specific T cell count
To determine the autoantigen specific T cell count using the flow cytometry
Measured: 1 month
Autoantigen specific T cell count
To determine the autoantigen specific T cell count using the flow cytometry
Measured: 6 months
Autoantigen specific T cell count
To determine the autoantigen specific T cell count using the flow cytometry
Measured: 1 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 month
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 year

Timeline

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

1 Mar 202226 Dec 2023

First posted26 Jan 2022
Study start1 Mar 2022
Primary completion26 Dec 2023
Study completion26 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05207995
Sponsor's protocol ID: IBCE_DM
Status last verified: Dec 2025
First submitted: 29 Nov 2021
Last updated: 2 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
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Recruiting
PAW-Hydrogel for Chronic Wound Healing
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase ½ Study to Evaluate the Safety and Feasibility of Autologous Tolerogenic Dendritic Cells in Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT05207995
Acronym / sponsor ID: IBCE_DM
Conditions: Diabetes Mellitus
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
Collaborators: Belarusian State Medical University
Study start: 1 Mar 2022 (actual)
Primary completion: 26 Dec 2023 (actual)
Study completion: 26 Dec 2023 (actual)
First posted: 26 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the safety and tolerability of the administration of tolerogenic dendritic cells in patients with type 1 diabetes mellitus.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells	Experimental	Biological: Autologous tolerogenic dendritic cells, Other: Standard treatment according to the clinical protocolsGroup 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Patients with Type 1 Diabetes Mellitus receiving standard treatment	Active comparator	Other: Standard treatment according to the clinical protocolsGroup 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Clinical diagnosis of Type 1 Diabetes Mellitus
The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
Written informed consent

Key exclusion criteria (7 listed)

The presence of any malignant tumor within the last 5 years
Acute or chronic diseases in the stage of decompensation
Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autologous tolerogenic dendritic cellsAutologous tolerogenic dendritic cells treated with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides (MSC-tolDC) injected subcutaneous.	Biological	Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Standard treatment according to the clinical protocolsStandard treatment of type 1 diabetes mellitus according to the clinical protocols	Other	Patients with Type 1 Diabetes Mellitus receiving standard treatment, Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells

Primary outcome

The glucose concentration in blood
Time frame: 1 month
To assess the glucose concentration in blood
The glycated hemoglobin concentration
Time frame: 1 month
To assess the β-cell function measured by the glycated hemoglobin in blood
The C-peptide level in blood
Time frame: 1 month
To assess the β-cell function measured by the C-peptide level
The glucose concentration in blood
Time frame: 6 months
To assess the glucose concentration in blood
The glycated hemoglobin concentration
Time frame: 6 months
To assess the β-cell function measured by the glycated hemoglobin in blood
The C-peptide level in blood
Time frame: 6 months
To assess the β-cell function measured by the C-peptide level
The glucose concentration in blood
Time frame: 1 year
To assess the glucose concentration in blood
The glycated hemoglobin concentration
Time frame: 1 year
To assess the β-cell function measured by the glycated hemoglobin in blood
The C-peptide level in blood
Time frame: 1 year
To assess the β-cell function measured by the C-peptide level
Autoantigen specific T cell count
Time frame: 1 month
To determine the autoantigen specific T cell count using the flow cytometry
Autoantigen specific T cell count
Time frame: 6 months
To determine the autoantigen specific T cell count using the flow cytometry
Autoantigen specific T cell count
Time frame: 1 year
To determine the autoantigen specific T cell count using the flow cytometry
Adverse effects associated with the therapy
Time frame: 1 month
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Time frame: 1 year
Determination of adverse effects associated with the therapy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

antonevich.n@gmail.com Antonevich, Dr study director

the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Tatiana Mokhort, Prof study director

Belarusian State Medical University

Andrei Y Hancharou, Dr. study director

The Institute for Biophysics and Cell Engineering of the NAS of Belarus

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Dec 2025. 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 Belarus. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The glucose concentration in blood (time frame: 1 month). The study lists 14 primary outcomes in all. 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 NCT05207995.

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 2 Dec 2025.