Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441658
• Other study ID #: DFSC-2020(CR)-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 10, 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: Shanghai East Hospital
• Contact: wang congrong, doctor
• Phone: +86-021-38804518
• Email: wcr601[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Mesenchymal Stem Cells
• Type 2 Diabetes

Intervention

Biological:
• Umbilical Cord Mesenchymal Stem Cells
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
• saline
saline containing human albumin will be infused to the control group

Locations

Country	Name	City	State
China	Shanghai East Hospital, Shanghai Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes in HbA1C level	The changes in HbA1C level after transplantation	24 weeks after treatment
Secondary	Reduction of insulin requirement	Reduction of insulin requirement after transplantation	24 weeks after treatment
Secondary	The changes in blood glucose level	The changes in blood glucose level after transplantation	24 weeks after treatment