Feasibility Study for Fibroblast Autologous Skin Grafts
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01964859|
Recruitment Status : Recruiting
First Posted : October 17, 2013
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Wounds and Injuries||Biological: autologous skin fibroblasts||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Sites are labeled as A, B and C and masked for outcomes assessors-- but these are all in the same subject.|
|Primary Purpose:||Basic Science|
|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.|
|Actual Study Start Date :||January 7, 2015|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Experimental: autologous skin fibroblasts
we are comparing 3 injection sites in the same individual
Biological: autologous skin fibroblasts
- Cytoplasmic size increase [ Time Frame: 6 months ]Volar keratinocytes have larger area of the cytoplasm. We will quantitate the area of cytoplasm of non-volar keratinocytes to see if they increase selectively with volar fibroblasts as opposed to other fibroblasts injections or vehicle. The change in the area of cytoplasm of non-volar keratinocytes will be measured. The units of this measurement are a ratio of cytoplasmic area to total cellular area as a control.
- Durometer reading [ Time Frame: 6 months ]Durometers measure the firmness of the skin. We will measure all sites to see if the area injected with volar fibroblasts is more firm. The units of measurement is in Durometer Units.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964859
|Contact: Ruizhi Wangemail@example.com|
|United States, Maryland|
|Johns Hopkins School of Medicine, Dermatology Department||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Sherry Leung 410-502-7546 firstname.lastname@example.org|
|Principal Investigator: Luis Garza, MD, PhD|
|Principal Investigator:||Luis Garza, MD, PhD||Department of Dermatology, Johns Hopkins School of Medicine|