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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Shanghai East Hospital
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Updated on 16 February 2024
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body mass index
hypoglycemic agents
antidiabetic agent
antidiabetic agents

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 treatmentincluding 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.

Details
Condition NIDDM, diabetes mellitus, type 2, Diabetes Mellitus, diabetes (pediatric), cells mesenchymal, diabetes (pediatric), diabetes mellitus, type 2
Age 30years - 75years
Treatment Saline, Umbilical Cord Mesenchymal Stem Cells
Clinical Study IdentifierNCT04441658
SponsorShanghai East Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Type 2 diabetes
The course of diabetes is 5-15 years
20kg/m2body mass index (BMI)30 kg /m2
7.5% HbA1c10%
Insulin dose and other oral antidiabetic drugs doses should be stable over the 3 months prior to randomization

Exclusion Criteria

Heavy allergic constitution or an allergy to any component used in cell culture
Being treated with drug (GlucocorticoidsTricyclic Antidepressive Agents,etc.) affect the metabolism of glucose in the past 1 month
other causes of diabetes
All kinds of acute complications such as diabetic ketoacidosis and non-ketohyperosmotic syndrome were screened in the past 6 months
Having evidence of ongoing or frequent/severe hypoglycemia in the past 6 months
Severe cardiovascular and cerebral eventsoccurrence of heart failure NYHA Classification III or IV, myocardial infarction, cerebral infarction, cerebral hemorrhage within 6 months before the observation period
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
Positive results of HbsAgAnti-HCVHIV or syphilis
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)
Ongoing pregnancy or absence of effective contraception in women with childbearing potential
Patients who had received other stem cell therapy before screening
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