Stem Cell Therapy to Improve Burn Wound Healing

Skin Burn Degree Second Clinical Trial

Official title: A Pilot Safety Study of the Administration of Mesenchymal Stem Cells (MSC) in the Treatment of Burn Wounds

Status Completed

Clinical Trial Summary

This study will determine the safety of allogeneic stem cell therapy from healthy donors, for 2nd degree burn wounds of less than 20% Total Body Surface Area (TBSA), at four different dose levels.

Clinical evaluation will take place every 1 to 4 weeks intervals until wound closure, and then monthly for 6 months following the last administration of MSCs.

Once the safety and dose-response analysis in Phase 1 is completed, an expanded trial will be initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Phase 1 will establish the maximum safe dose that will be used in the Phase II trial.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Burns
• Skin Burn Degree Second

• NCT number: NCT02104713
• Study type: Interventional
• Source: University of Miami
• Status: Completed
• Phase: Phase 1
• Start date: June 4, 2014
• Completion date: March 18, 2019