Feasibility Study for Fibroblast Autologous Skin Grafts



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:1/17/2019
Start Date:December 2014
End Date:December 2022
Contact:Ruizhi Wang
Email:rwang53@jhmi.edu
Phone:410-502-7546

Use our guide to learn which trials are right for you!

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.

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.

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.

Inclusion Criteria:

- may be male or female

- must be between 18 years and 65 years of age

- must be medically able to undergo the administration of study material determined by
laboratory tests obtained 2 weeks before baseline for which the investigator
identified no significant abnormality

- provide informed consent for participation

- females of childbearing potential must: have a negative pregnancy test at screening,
agree not be become pregnant or breastfeed for the period of the study, be willing to
use reliable form of contraception during the study

- be willing to comply with the scheduled visits, biopsy/injection procedures, wound
care instructions, and treatment plan.

Exclusion Criteria:

- received any investigational drug within 30 days prior to study entry

- an allergy history to any study materials including anesthetic, antibiotics,
antimycotics, dimethyl sulfoxide, human albumin, bovine constituents, hetastarch,
penicillin, streptomycin, amphotericin

- pregnant, lactating, or trying to become pregnant

- history of keloid formation

- an active wound

- significant medical history of infectious disease (HIV, Human T- Lymphotrophic virus
(HTLV) I/II, hepatitis B, hepatitis C), autoimmune conditions, cancer

- current skin disease (eczema, psoriasis, lichen planus)

- diagnosis of uncontrolled diabetes

- active smoker

- use of chronic immunosuppressive therapies such as oral and topical steroids.
We found this trial at
1
site
Baltimore, Maryland 21287
Principal Investigator: Luis Garza, MD, PhD
Phone: 410-502-7546
?
mi
from
Baltimore, MD
Click here to add this to my saved trials