Immunotherapy with Autologous Tregs in T1DM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ex vivo Expanded Human Autologous Regulatory T Cells, Routine Care.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 8 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM
Overview
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.
Interventions
- Biological Ex vivo Expanded Human Autologous Regulatory T Cells
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. - Other Routine Care
Routine care is provided to all participants according to clinical guidelines for T1DM.
Primary outcome measures
- 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 outcome measures (1)
- Therapeutic effects on diabetes-related outcomes [Time frame: From enrollment to the end of treatment at 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing Uni — Nanjing
Identifiers
NCT: NCT06708780 · 2021-427-TREG