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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441658
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai East Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 10, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The changes in HbA1C level [ Time Frame: 24 weeks after treatment ]
    The changes in HbA1C level after transplantation


Secondary Outcome Measures :
  1. Reduction of insulin requirement [ Time Frame: 24 weeks after treatment ]
    Reduction of insulin requirement after transplantation

  2. The changes in blood glucose level [ Time Frame: 24 weeks after treatment ]
    The changes in blood glucose level after transplantation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441658


Contacts
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Contact: wang congrong, doctor +86-021-38804518 wcr601@163.com
Contact: liu zhongmin, doctor +86-021-38804518 liu.zhongmin@tongji.edu.cn

Locations
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China, Shanghai
Shanghai East Hospital, Shanghai Tongji University Recruiting
Shanghai, Shanghai, China, 200120
Contact: wang congrong, doctor         
Sponsors and Collaborators
Shanghai East Hospital
Investigators
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Principal Investigator: wang congrong, doctor Shanghai East Hospital. China.
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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT04441658    
Other Study ID Numbers: DFSC-2020(CR)-02
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases