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

• Sponsor: Shanghai East Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04441658
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 31.7
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Mesenchymal Stem Cells	Biological: Umbilical Cord Mesenchymal Stem Cells; Biological: saline	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Apr 10, 2020
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group 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.	Biological: Umbilical Cord Mesenchymal Stem Cells; human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
Placebo Comparator: control group The control group will be given the same dose of saline containing human albumin.	Biological: saline; saline containing human albumin will be infused to the control group

Outcome Measures

Primary Outcome Measures

1. The changes in HbA1C level [24 weeks after treatment]

   The changes in HbA1C level after transplantation

Secondary Outcome Measures

1. Reduction of insulin requirement [24 weeks after treatment]

   Reduction of insulin requirement after transplantation

2. The changes in blood glucose level [24 weeks after treatment]

   The changes in blood glucose level after transplantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai East Hospital, Shanghai Tongji University	Shanghai	Shanghai	China	200120

Sponsors and Collaborators

• Shanghai East Hospital

Investigators

• Principal Investigator: wang congrong, doctor, Shanghai East Hospital. China.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai East Hospital
• ClinicalTrials.gov Identifier: NCT04441658
• Other Study ID Numbers: DFSC-2020(CR)-02
• First Posted: Jun 22, 2020
• Last Update Posted: Jun 22, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai East Hospital: Umbilical Cord Mesenchymal Stem Cells; Type 2 Diabetes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 22, 2020