Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus
NCT04441658 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2020-06-22
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.
Conditions
- Type 2 Diabetes
- Mesenchymal Stem Cells
Interventions
- 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
Sponsors & Collaborators
-
Shanghai East Hospital
lead OTHER
Principal Investigators
-
wang congrong, doctor · Shanghai East Hospital, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-10
- Primary Completion
- 2022-07-31
- Completion
- 2022-12-31
Countries
- China
Study Locations
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