NCT04441658

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Mesenchymal Stem Cells

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-04-10
• Primary completion: 2022-07-01
• Completion: 2022-12-01
• First posted: 2020-06-22
• Last updated: 2020-06-22

Locations

1 site across 1 country: China