UCMSCs Combined With Standard Therapy for the Treatment of Newly Diagnosed Type 1 Diabetes
NCT ID: NCT06407297
Last Updated: 2024-12-27
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
NA
24 participants
INTERVENTIONAL
2024-05-23
2026-05-01
Brief Summary
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Detailed Description
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A total number of 24 patients will be enrolled in the study and followed for one year after UCMSCs/placebo treatment. Patients 8-18 years of age, both male and female, diagnosed for type 1 diabetes will be eligible. Providing informed consent and fulfillment of inclusion criteria and no exclusion criteria, they will within 6 months of diagnosis be randomized.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental
UCMSCs
Peripheral intravenous infusion of umbilical cord mesenchymal stem cells
Placebo Comparator
Placebo
Peripheral intravenous infusion of Placebo
Interventions
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UCMSCs
Peripheral intravenous infusion of umbilical cord mesenchymal stem cells
Placebo
Peripheral intravenous infusion of Placebo
Eligibility Criteria
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Inclusion Criteria
2. Presence of at least one pancreatic autoantibody, or idiopathic type 1 diabetes mellitus (T1DM) with negative autoantibody testing.
3. Ages 8 to 18 years, regardless of gender.
4. Newly diagnosed T1DM within the past 6 months.
5. Fasting C-peptide ≥0.1 nmol/L and postprandial 2-hour C-peptide \>0.2 nmol/L.
6. Voluntary acceptance of stem cell transplantation therapy by the individual, their family members, or legal guardians, and signing of an informed consent form.
Exclusion Criteria
2. Severe allergic constitution.
3. BMI \<14 or \>35.
4. History of other autoimmune diseases, hematologic disorders.
5. HIV positive, carrier of viral hepatitis, active phase of viral hepatitis, or other uncontrolled infectious diseases.
6. History of acute pancreatitis, pulmonary embolism, or other thrombotic diseases, as well as severe diseases of the heart, liver, kidneys, respiratory system, nervous system, etc.
7. Suffering from gestational diabetes, monogenic diabetes, diabetes caused by pancreatic injury, or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction, or acromegaly-induced diabetes);
8. Pregnancy or planning pregnancy within 3 months before or after treatment, as well as breastfeeding women.
9. Mental illness, alcohol or drug abuse, inability to comply with treatment.
10. Known or suspected tumors.
11. According to the investigator's judgment, there are other clinical conditions that may endanger the safety of the subjects.
8 Years
18 Years
ALL
Yes
Sponsors
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Shanghai Changzheng Hospital
OTHER
Responsible Party
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Principal Investigators
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Hao Yin
Role: PRINCIPAL_INVESTIGATOR
Shanghai Changzheng Hospital
Locations
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Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hao Yin
Role: primary
Other Identifiers
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CZYZ-T1DM-2023-IIT
Identifier Type: -
Identifier Source: org_study_id