Status:
UNKNOWN
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Shanghai East Hospital
Conditions:
Type 2 Diabetes
Mesenchymal Stem Cells
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
PHASE2
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-w...
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-w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04441658
Start Date
April 10 2020
End Date
December 1 2022
Last Update
June 22 2020
Active Locations (1)
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1
Shanghai East Hospital, Shanghai Tongji University
Shanghai, Shanghai Municipality, China, 200120