Feasibility Study for Fibroblast Autologous Skin Grafts (NCT01964859) | Clinical Trial Compass
RecruitingPhase 2
Feasibility Study for Fibroblast Autologous Skin Grafts
United States80 participantsStarted 2015-01-07
Plain-language summary
This research is being done to determine if investigators can change skin from one type to another. Specifically, investigators are interested in making normal skin into the thicker skin found on our palms and soles.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* May be male or female
* Must be between 18 years and 65 years of age
* In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained within 7 days before baseline for which the investigator identified no clinically significant abnormality.
* Be able to comprehend the informed consent document and provide consent for participation
* Females of childbearing potential must:
* have a negative pregnancy test at screening
* agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study
* be willing to use a reliable form of contraception during the study
* Have healthy skin as determined by the PI or study Nurse Practitioner.
* Be willing and able to comply with the scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.
Exclusion Criteria:
* Having received any investigational drug within 30 days prior to study entry
* An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, or hetastarch
* Pregnant, lactating, or trying to become pregnant
* A history of keloid formation
* An active nonhealing wound
* Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, meta…