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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

Tracking Information
First Submitted Date  ICMJE June 19, 2020
First Posted Date  ICMJE June 22, 2020
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE April 10, 2020
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
The changes in HbA1C level [ Time Frame: 24 weeks after treatment ]
The changes in HbA1C level after transplantation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • Reduction of insulin requirement [ Time Frame: 24 weeks after treatment ]
    Reduction of insulin requirement after transplantation
  • The changes in blood glucose level [ Time Frame: 24 weeks after treatment ]
    The changes in blood glucose level after transplantation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes
  • Mesenchymal Stem Cells
Intervention  ICMJE
  • Biological: Umbilical Cord Mesenchymal Stem Cells
    human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
  • Biological: saline
    saline containing human albumin will be infused to the control group
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Umbilical Cord Mesenchymal Stem Cells
  • Placebo Comparator: control group
    The control group will be given the same dose of saline containing human albumin.
    Intervention: Biological: saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: wang congrong, doctor +86-021-38804518 wcr601@163.com
Contact: liu zhongmin, doctor +86-021-38804518 liu.zhongmin@tongji.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04441658
Other Study ID Numbers  ICMJE DFSC-2020(CR)-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai East Hospital
Study Sponsor  ICMJE Shanghai East Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: wang congrong, doctor Shanghai East Hospital. China.
PRS Account Shanghai East Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP