Autologous Volar Fibroblast Injection Into the Stump Site of Amputees (NCT03947450) | Clinical Trial Compass
RecruitingPhase 2
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
United States50 participantsStarted 2019-09-05
Plain-language summary
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
Patients interested in study participation must meet all of the following inclusion criteria:
* May be male or female
* Must be between 18 years and 65 years of age
* Must have a below the knee amputation.
* Must be using a prosthetic for the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month.
* 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
* 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:
Patients meeting any of the following criteria will be ineligible for study participation:
* A skin erosion deeper than the skin dermis.
* Having received any investigational drug within 30 days prior to study entry
* An allergy history to any study materials including local anesthetic, dimethyl sulfoxid…