Mesenchymal Stem Cells, Type 2 Diabetes
Conditions
Keywords
Umbilical Cord Mesenchymal Stem Cells, Type 2 Diabetes
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.
Interventions
BIOLOGICALUmbilical Cord Mesenchymal Stem Cells
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
BIOLOGICALsaline
saline containing human albumin will be infused to the control group
Sponsors
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes in HbA1C level | 24 weeks after treatment | The changes in HbA1C level after transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of insulin requirement | 24 weeks after treatment | Reduction of insulin requirement after transplantation |
| The changes in blood glucose level | 24 weeks after treatment | The changes in blood glucose level after transplantation |
Countries
China
Contacts
Primary Contactwang congrong, doctor
Backup Contactliu zhongmin, doctor
Outcome results
None listed