Clinical trial NCT04441658: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Mesenchymal Stem Cells
Keywords: Umbilical Cord Mesenchymal Stem Cells
Type 2 Diabetes
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes；
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:

1. Heavy allergic constitution or an allergy to any component used in cell culture.
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.

Primary outcomes:
measure: The changes in HbA1C level
timeFrame: 24 weeks after treatment
Secondary outcomes:
measure: Reduction of insulin requirement
timeFrame: 24 weeks after treatment
measure: The changes in blood glucose level
timeFrame: 24 weeks after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Shanghai Tongji University
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital, China
name: wang congrong, doctor
role: PRINCIPAL_INVESTIGATOR
References: