NCT01374854

Umbilical Mesenchymal Stem Cells and Mononuclear Cells Infusion in Type 1 Diabetes Mellitus

Umbilical Mesenchymal Stem Cells and Mononuclear Cells Infusion in Type 1 Diabetes Mellitus: A Randomized Controlled Open-label Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Umbilical mesenchymal stem cells (UC-MSCs) infusion is supposed be a promising regeneration therapy with mild side effect as indicated by large quantities of animal experiments and some clinical trials. There are few UC-MSCs clinical trials with regard to diabetes mellitus. The investigators hypothesize that infusion of USC-MSCs may provide multiple signals for beta-cell regeneration and even re-differentiate into local tissues in diabetes mellitus patients, resulting in improvement of diabetic control, of which the effect may be promoted by concomitant infusion of bone marrow mononuclear cells and maximized by intra-arterial pancreatic infusion through angiography.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Umbilical mesenchymal stem cell (UC-MSCs) infusion	1×10\^6/kg UC-MSCs is infused through pancreatic artery along with mononuclear cells by interventional therapy and another same dose of UC-MSCs is administered one week post-intervention.
DRUG	traditional therapy	exogenous insulin injection daily

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-12-01
• Completion: 2014-12-01
• First posted: 2011-06-16
• Last updated: 2012-11-20

Locations

1 site across 1 country: China