Actively Recruiting
Immunotherapy with Autologous Tregs in T1DM
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2024-11-27
20
Participants Needed
1
Research Sites
242 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
S
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunotherapy with Autologous Tregs in T1DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Type 1 Diabetes Mellitus based on 2021 Chinese Guidelines for Diagnosis and Treatment
- Aged between 8 and 65 years
- Have at least one positive islet autoantibody and/or fasting C-peptide level not exceeding 300 pmol/L
- Able to provide written, signed, and dated informed consent and willing to follow study requirements
You will not qualify if you...
- Uncontrolled diabetic ketoacidosis
- Severe allergic constitution
- Known or suspected tumors
- Acute pancreatitis or severe heart, liver, kidney, rheumatic immune, respiratory, nervous, or infectious diseases
- Gestational diabetes, single gene mutation diabetes, diabetes caused by pancreatic damage, or other secondary diabetes conditions such as from Cushing's syndrome, thyroid dysfunction, or acromegaly
- Women who are pregnant, planning pregnancy before or after treatment, or breastfeeding
- Mental illness, alcohol or drug abuse that would interfere with treatment
- Any other clinical conditions judged by the investigator to risk participant safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
D
Dr. Lu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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