Recruiting NCT01964859

Feasibility Study for Fibroblast Autologous Skin Grafts

Phase II Interventional Wounds and Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: autologous skin fibroblasts, Filler Product.
Who it may be relevant to: Registry conditions: Wounds and Injuries. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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.

Detailed description

To change the skin identity investigators propose to take skin cells from a person's own sole or palm (these are called "autologous skin fibroblasts"), multiply them in the lab, inject the cells (now called a "graft") back into the same person but at a different site of skin like the buttock, and then eventually remove the injected cells to see if they caused the skin to change.

Investigators hope that information from this study will help with problems like skin break-down in patients with amputations and prosthetics. The skin at their stump was not meant to withstand the pressure and friction of prosthetics and this study is the first step in trying to convert stump skin to palm/sole-like skin. In some select subjects the investigators will test if the addition of an FDA approved filler product might enhance cellular efficacy.

Interventions

Biological autologous skin fibroblasts
autologous skin fibroblasts
Biological Filler Product
In some select subjects the investigators will test if the addition of an FDA approved filler product Bellafill might enhance cellular efficacy.

Primary outcome measures

Cytoplasmic size increase [Time frame: 6 months]

Secondary outcome measures (1)

Durometer reading [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Basic science

Study locations

United States · 1 center

Johns Hopkins School of Medicine, Dermatology Department — Baltimore

Identifiers

NCT: NCT01964859 · NA_00068684 · 1R01AR064297-01A1

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗