Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2023-04-12
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treg Group
Participants in this group are transplanted with expanded autologous Tregs in addition to routine therapy for T1DM.
Ex vivo Expanded Human Autologous Regulatory T Cells
Peripheral blood component donation is used to collect Treg cells for ex vivo expansion, with technical guidance provided by the Center for Biotechnology Drug Development at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.
Routine Care
Routine care is provided to all participants according to clinical guidelines for T1DM.
Control Group
Participants in this group receive only routine therapy for T1DM.
Routine Care
Routine care is provided to all participants according to clinical guidelines for T1DM.
Interventions
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Ex vivo Expanded Human Autologous Regulatory T Cells
Peripheral blood component donation is used to collect Treg cells for ex vivo expansion, with technical guidance provided by the Center for Biotechnology Drug Development at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.
Routine Care
Routine care is provided to all participants according to clinical guidelines for T1DM.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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 syndrome, thyroid dysfunction or acromegaly, etc.);
* 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 subjects.
8 Years
65 Years
ALL
No
Sponsors
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Shanghai Institute of Materia Medica, Chinese Academy of Sciences
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Zhu DaLong
Professor
Locations
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The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Prof. Zhu, MD
Role: backup
Prof. Zhou, PhD
Role: backup
Dr. Lu, MD
Role: backup
Other Identifiers
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2021-427-TREG
Identifier Type: -
Identifier Source: org_study_id