Stem Cell Therapy to Improve Burn Wound Healing

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

June 4, 2014

Primary Completion Date

March 18, 2019

Study Completion Date

March 18, 2019

Conditions
Skin Burn Degree Second
Interventions
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~1. Initial dose level will be 2.5 x 10³ Allogeneic MSCs cells/square cm.~2. Second dose level 5 X 10³ Allogeneic MSCs cells/square cm.~3. Third dose level 1 X 10⁴ Allogeneic MSCs cells/square cm.~4. Fourth dose level 2 X 10⁴ Allogeneic MSCs cells/square cm.~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."

Trial Locations (1)

33136

University of Miami, Miami

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

E.Badiavas

OTHER

NCT02104713 - Stem Cell Therapy to Improve Burn Wound Healing | Biotech Hunter | Biotech Hunter