Tests patient's own regulatory T cells in type 1 diabetes
Tests safety of patients' own regulatory T cells in people with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Immunotherapy with Autologous Tregs in T1DM
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 65 years old?
Source: NCT06708780, who can take part
Where in China
- The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Trial code
- NCT06708780
- Record updated
- 27 November 2024
- Original description
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.Read full original descriptionShow less
Clinical Safety and Therapeutic Effects of 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.
Inclusion: 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: The condition of diabetic ketoacidosis has not been controlled; Severe allergic constitution; 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.); 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; Known or suspected tumor; Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.