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The safety and efficacy of autologous regulatroy T cells therapy in type 1 diabetes

The safety and efficacy of autologous regulatroy T cells therapy in type 1 diabetes

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052683
Enrollment
Unknown
Registered
2021-11-03
Start date
2021-11-15
Completion date
Unknown
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes

Interventions

Experimental group:intensive insulin therapy combined with autologous Treg transfusion
Control group:intensive insulin therapy alone

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the 1999 WHO diagnostic criteria for diabetes; 2. Agd 12 to 65 years; 3. At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L; 4. I and my family members or legal guardians voluntarily accept and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The condition of diabetic ketoacidosis has not been controlled; 2. Severe allergic constitution; 3. Known or suspected tumor; 4. Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases; 5. 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.); 6. Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding; 7. Mental illness, alcohol or drug abuse, unable to cooperate with treatment; 8. According to the judgment of the investigator, there are other clinical conditions that may endanger the safety of the subjects.

Design outcomes

Primary

MeasureTime frame
rate of clinical remission;

Secondary

MeasureTime frame
side effects;HbA1c;serum C peptide;

Countries

China

Contacts

Public ContactZhu Dalong

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

zhudalong@nju.edu.cn+86 13805150781

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026