Stem Cell Therapy to Improve Burn Wound Healing
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|ClinicalTrials.gov Identifier: NCT02104713|
Recruitment Status : Recruiting
First Posted : April 4, 2014
Last Update Posted : January 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Skin Burn Degree Second||Biological: Allogeneic (MSC's) Application to the Burn Wounds||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||June 2019|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104713
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Olga Orozco, CCRC 305-585-8160 firstname.lastname@example.org|
|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|