Stem Cell Therapy to Improve Burn Wound Healing
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.
|Skin Burn Degree Second||Biological: Allogeneic (MSC's) Application to the Burn Wounds||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Official Title:||A Pilot Safety Study of the Administration of Mesenchymal Stem Cells (MSC) in the Treatment of Burn Wounds|
- Monitoring for adverse events as Assessed by CTCAE v4.0 following administration of allogeneic MSCs to 2nd degree burn wounds. [ Time Frame: 1.5 years ]The study will consist of a dose escalation phase consisting of four dose levels. Each dose level will compare the safety of administering allogeneic MSCs, with 5 patients per group.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Experimental: Allogeneic (MSC's) Application to the Burn Wounds
Allogeneic (MSC's) Application to the Burn Wounds. The 1st group of 5 will be started on the lowest dose. If there are no adverse reactions, the 2nd group of 5 will receive a higher dose. This will be repeated for the 3rd and 4th groups with each receiving a higher dose.
Up to 2 administrations of cells per dose level to be given over a period of no more than 8 weeks. Each administration of cells will be no less than ten days apart and no more than 6 weeks apart.
Biological: Allogeneic (MSC's) Application to the Burn Wounds
Allogeneic (MSC's) Application to the Burn Wounds. The first group of 5 will be started on the lowest dose. If there are no adverse reactions, the second group of 5 will receive a higher dose. This will be repeated for the third and fourth groups with each receiving a higher dose
Up to 2 administrations of cells will be allowed per dose level to be given over a period of no more than 8 weeks. Each administration of cells will be no less than ten days apart and no more than 6 weeks apart.
Other Name: Stem Cells Application to the Burn Wounds
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02104713
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Olga Orozco, CCRC 305-585-8160 email@example.com|
|Principal Investigator: Carl I. Schulman, MD,PhD,MSPH,FACS|
|Sub-Investigator: Louis R. Pizano, MD,MBA,FACS|
|Sub-Investigator: Evangelos V. Badiavas, MD, PhD|
|Sub-Investigator: Nicholas Namias, MD,MBA,FACS,FCCM|
|Principal Investigator:||Carl Schulman, MD, PhD||University of Miami|