NCT06708780RecruitingPhase 1
Immunotherapy with Autologous Tregs in T1DM
Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 26 Nov 2024
- Start date
- 12 Apr 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Type 1 diabetes
- NCT number
- NCT06708780
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 12 Apr 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Known or suspected tumor;
- Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 8 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.