Back to resultsEfficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes, Mesenchymal Stem Cells
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Umbilical Cord Mesenchymal Stem Cells
saline
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Umbilical Cord Mesenchymal Stem Cells, Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes；
- The course of diabetes is 5-15 years;
- 20kg/m2≤body mass index (BMI)≤30 kg /m2；
- 7.5% ≤HbA1c≤10%；
- Insulin dose and other oral antidiabetic drugs doses should be stable over the 3 months prior to randomization.
Exclusion Criteria:
- 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.
Sites / Locations
- Shanghai East Hospital, Shanghai Tongji UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
control group
Arm Description
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.
The control group will be given the same dose of saline containing human albumin.
Outcomes
Primary Outcome Measures
The changes in HbA1C level
The changes in HbA1C level after transplantation
Secondary Outcome Measures
Reduction of insulin requirement
Reduction of insulin requirement after transplantation
The changes in blood glucose level
The changes in blood glucose level after transplantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04441658
Brief Title
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
Official Title
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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（including insulin） 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Mesenchymal Stem Cells
Keywords
Umbilical Cord Mesenchymal Stem Cells, Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The control group will be given the same dose of saline containing human albumin.
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Mesenchymal Stem Cells
Intervention Description
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
Intervention Type
Biological
Intervention Name(s)
saline
Intervention Description
saline containing human albumin will be infused to the control group
Primary Outcome Measure Information:
Title
The changes in HbA1C level
Description
The changes in HbA1C level after transplantation
Time Frame
24 weeks after treatment
Secondary Outcome Measure Information:
Title
Reduction of insulin requirement
Description
Reduction of insulin requirement after transplantation
Time Frame
24 weeks after treatment
Title
The changes in blood glucose level
Description
The changes in blood glucose level after transplantation
Time Frame
24 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes；
The course of diabetes is 5-15 years;
20kg/m2≤body mass index (BMI)≤30 kg /m2；
7.5% ≤HbA1c≤10%；
Insulin dose and other oral antidiabetic drugs doses should be stable over the 3 months prior to randomization.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wang congrong, doctor
Phone
+86-021-38804518
Email
wcr601@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
liu zhongmin, doctor
Phone
+86-021-38804518
Email
liu.zhongmin@tongji.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wang congrong, doctor
Organizational Affiliation
Shanghai East Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital, Shanghai Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wang congrong, doctor
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
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