Feasibility Study for Fibroblast Autologous Skin Grafts

Launched by JOHNS HOPKINS UNIVERSITY · Oct 15, 2013

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help patients with wounds and injuries by studying how to change normal skin into thicker skin, similar to what we have on our palms and soles. The goal is to see if this technique can improve healing for people who might benefit from stronger skin in areas that are injured or have wounds.

To participate in this study, you need to be between 18 and 65 years old and have healthy skin, as determined by the research team. You should be medically able to join the study and understand the information provided to you. Additionally, women who could become pregnant must have a negative pregnancy test and agree to use contraception during the study. If you decide to join, you can expect to attend scheduled visits, follow care instructions, and possibly undergo some procedures like biopsies (small skin samples). It's important to note that certain health conditions, skin diseases, and treatments may exclude you from participating, so the research team will carefully review your medical history.

Gender

ALL

Eligibility criteria

• 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, 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