Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT04441658
Last Updated: 2020-06-22
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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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2020-04-10
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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experimental group
The volunteers of the experimental group will be given peripheral intravenously a dose of 0.75\*10\^6/ kg human umbilical cord mesenchymal stem cells at 0,1,5,6 week.
Umbilical Cord Mesenchymal Stem Cells
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
control group
The control group will be given the same dose of saline containing human albumin.
saline
saline containing human albumin will be infused to the control group
Interventions
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Umbilical Cord Mesenchymal Stem Cells
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
saline
saline containing human albumin will be infused to the control group
Eligibility Criteria
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Inclusion Criteria
2. The course of diabetes is 5-15 years;
3. 20kg/m2≤body mass index (BMI)≤30 kg /m2；
4. 7.5% ≤HbA1c≤10%；
5. Insulin dose and other oral antidiabetic drugs doses should be stable over the 3 months prior to randomization.
Exclusion Criteria
2. Being treated with drug (Glucocorticoids，Tricyclic Antidepressive Agents,etc.) affect the metabolism of glucose in the past 1 month;
3. other causes of diabetes;
4. All kinds of acute complications such as diabetic ketoacidosis and non-ketohyperosmotic syndrome were screened in the past 6 months;
5. Having evidence of ongoing or frequent/severe hypoglycemia in the past 6 months;
6. Severe cardiovascular and cerebral events：occurrence of heart failure NYHA Classification III or IV, myocardial infarction, cerebral infarction, cerebral hemorrhage within 6 months before the observation period;
7. Patients with abnormal liver and kidney function: AST and ALT exceeding 2.5 times of the normal upper limit, and serum creatinine exceeding 1.5 mg/dl for men, exceeding 1.4 mg/dl for women;
8. Positive results of HbsAg、Anti-HCV、HIV or syphilis;
9. Patients suffering from other serious systemic diseases (such as malignancy, central nervous system,cardiovascular system, blood system, digestive system,endocrine system,respiratory system, genitourinary system, immune system and);
10. Ongoing pregnancy or absence of effective contraception in women with childbearing potential;
11. Patients who had received other stem cell therapy before screening.
30 Years
75 Years
ALL
No
Sponsors
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Shanghai East Hospital
OTHER
Responsible Party
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Principal Investigators
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wang congrong, doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital, China
Locations
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Shanghai East Hospital, Shanghai Tongji University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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wang congrong, doctor
Role: primary
Other Identifiers
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DFSC-2020(CR)-02
Identifier Type: -
Identifier Source: org_study_id
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