Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
30
1 country
1
Brief Summary
This study is a 24-week single-center, randomized, double-blind, placebo-controlled trial. The trial includes a 3-week early screening and lifestyle education period, 6-week treatment period, and 18-week follow-up period. Chinese type 2 diabetic subjects receiving traditional hypoglycemic treatment were randomly assigned to umbilical cord mesenchymal stem cell or placebo infusion therapy to observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Apr 2020
Longer than P75 for phase_1 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2020
CompletedFirst Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJune 22, 2020
June 1, 2020
2.2 years
June 19, 2020
June 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The changes in HbA1C level
The changes in HbA1C level after transplantation
24 weeks after treatment
Secondary Outcomes (2)
Reduction of insulin requirement
24 weeks after treatment
The changes in blood glucose level
24 weeks after treatment
Study Arms (2)
experimental group
EXPERIMENTALThe 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.
control group
PLACEBO COMPARATORThe control group will be given the same dose of saline containing human albumin.
Interventions
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
Eligibility Criteria
You may qualify if:
- Type 2 diabetes；
- The course of diabetes is 5-15 years;
- kg/m2≤body mass index (BMI)≤30 kg /m2；
- % ≤HbA1c≤10%；
- Insulin dose and other oral antidiabetic drugs doses should be stable over the 3 months prior to randomization.
You may not qualify if:
- Heavy allergic constitution or an allergy to any component used in cell culture.
- Being treated with drug (Glucocorticoids，Tricyclic Antidepressive Agents,etc.) affect the metabolism of glucose in the past 1 month;
- other causes of diabetes;
- All kinds of acute complications such as diabetic ketoacidosis and non-ketohyperosmotic syndrome were screened in the past 6 months;
- Having evidence of ongoing or frequent/severe hypoglycemia in the past 6 months;
- 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;
- 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;
- Positive results of HbsAg、Anti-HCV、HIV or syphilis;
- 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);
- Ongoing pregnancy or absence of effective contraception in women with childbearing potential;
- Patients who had received other stem cell therapy before screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai East Hospital, Shanghai Tongji University
Shanghai, Shanghai Municipality, 200120, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
wang congrong, doctor
Shanghai East Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2020
First Posted
June 22, 2020
Study Start
April 10, 2020
Primary Completion
July 1, 2022
Study Completion
December 1, 2022
Last Updated
June 22, 2020
Record last verified: 2020-06