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NCT Number: NCT06708780

Immunotherapy with Autologous Tregs in T1DM

Type 1 diabetes (T1D) is an autoimmune disease characterized by a progressive immune distruction of pancreat beta cells and deterioration of endogenous insulin secretion. Regulatory T cells (Treg) are fuctionally deficient in T1D, leading to the loss of immune tolerance to the islets and the initiation of an autoimmune attack. Previouse studies have revealed the potential theraputic effects of autologous Treg transplantation in T1D. We have modified the preparation protocol for autologous Tregs. The purpose of this study is to assess the safety and effect of autologous Treg therapy in patients with T1D.

Recruiting

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Key information

Age range

8 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Dr. Lu, MD

CONTACT

Dr. Lu, medical doctor

CONTACT

[email protected]

0086-025-68182432

Prof. Zhou, PhD

CONTACT

Prof. Zhu, MD

CONTACT

Prof. Zhu, Medical doctor

CONTACT

[email protected]

0086-025-68182432

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria of T1DM based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes;
  • Aged 8 to 65 years;
  • At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L;
  • Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.

Exclusion criteria

  • The condition of diabetic ketoacidosis has not been controlled;
  • Severe allergic constitution;
  • Known or suspected tumor;
  • Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases.
  • Suffering from gestational diabetes mellitus, single gene mutation diabetes mellitus, diabetes mellitus caused by pancreatic damage or other secondary diabetes mellitus (such as diabetes mellitus caused by Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
  • Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.
  • Mental illness, alcohol or drug abuse, unable to cooperate with treatment;
  • According to the judgment of the investigator, there are other clinical conditions that may endanger the safety of the subjects.

Treatment and study plan

Ex vivo Expanded Human Autologous Regulatory T Cells

Biological

Peripheral blood component donation is used to collect Treg cells for ex vivo expansion, with technical guidance provided by the Center for Biotechnology Drug Development at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.

Routine care

Other

Routine care is provided to all participants according to clinical guidelines for T1DM.

Primary outcomes

  1. Number of Participants with adverse events, laboratory abnormalities and other signs of toxicity.

    Time frame: From enrollment to the end of treatment at 1 year

Secondary outcomes

  1. Therapeutic effects on diabetes-related outcomes

    Time frame: From enrollment to the end of treatment at 1 year

    Therapeutic effects on diabetes-related outcomes 1 year after intervention include: 1) C-peptide response during mixed meal tolerance test, reported as the change from baseline in the fasting level, postprandial level and area under the curve; 2) Insulin Use; 3) Hemoglobin A1c.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Collaborators

  • Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Registry information

Official study title

Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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