RECRUITING

Feasibility Study for Fibroblast Autologous Skin Grafts

Conditions

Wounds and Injuries healthy skin prosthetics amputations dermal fibroblasts

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility Study for Fibroblast Autologous Skin Grafts: Biopsy of Skin Fibroblasts, Expansion in Cell Therapy Core, Topical Injection of Fibroblasts, and Subsequent Removal of Graft for Laboratory Studies.

Quick Facts

Study Start:2015-01-07

Study Completion:2028-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01964859

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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, metastatic cancer, infectious diseases such as HIV, Human T-lymphotropic virus (HTLV) I/II, Hepatitis B, Hepatitis C). Biopsies taken from individuals with infections that are not allowed to enter the cell therapy core will make it such that these individuals cannot participate. * Specifically we will exclude those with autoimmune diseases affecting the skin such as lupus. * Having current skin diseases (i.e. extreme and active eczema, psoriasis, lichen planus) that the investigator feels is not safe for study participation * A diagnosis of uncontrolled diabetes * Active smoker during the study * We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation. * Known bovine or meat sensitivity or severe allergies manifested by anaphylaxis to any product * Known bleeding disorder

Inclusion Criteria

Exclusion 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.

* 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, metastatic cancer, infectious diseases such as HIV, Human T-lymphotropic virus (HTLV) I/II, Hepatitis B, Hepatitis C). Biopsies taken from individuals with infections that are not allowed to enter the cell therapy core will make it such that these individuals cannot participate.
* Specifically we will exclude those with autoimmune diseases affecting the skin such as lupus.
* Having current skin diseases (i.e. extreme and active eczema, psoriasis, lichen planus) that the investigator feels is not safe for study participation
* A diagnosis of uncontrolled diabetes
* Active smoker during the study
* We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.
* Known bovine or meat sensitivity or severe allergies manifested by anaphylaxis to any product
* Known bleeding disorder

Contacts and Locations

Study Contact

Ruizhi Wang

CONTACT

410-502-7546

rwang53@jhmi.edu

Principal Investigator

Luis Garza, MD, PhD

PRINCIPAL_INVESTIGATOR

Department of Dermatology, Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins School of Medicine, Dermatology Department

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Luis Garza, MD, PhD, PRINCIPAL_INVESTIGATOR, Department of Dermatology, Johns Hopkins School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-01-07

Study Completion Date2028-11-01

Study Record Updates

Study Start Date2015-01-07

Study Completion Date2028-11-01

Terms related to this study

Keywords Provided by Researchers

healthy skin
wounds and injuries
prosthetics
amputations
dermal fibroblasts

Additional Relevant MeSH Terms

Wounds and Injuries