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New treatment option for Type 1 Diabetes Mellitus
Official title Immunotherapy with Autologous Tregs in T1DM
ClinicalTrials.gov ID: NCT06708780
What this study is testing
What is Ex vivo Expanded Human Autologous Regulatory T Cells?
Ex vivo Expanded Human Autologous Regulatory T Cells is an investigational medicine, being studied as a potential treatment for type 1 diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 65
You may be able to join if
- 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.
You likely can't join if
- 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...
- Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.
See the full eligibility 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.
- 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...
- 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 people.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.