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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AR064297-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| United States Department of Defense | FED |
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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. In some select subjects the investigators will test if the addition of an FDA approved filler product might enhance cellular efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous skin fibroblasts | Experimental | The investigators are comparing 3 injection sites in the same individual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous skin fibroblasts | Biological | autologous skin fibroblasts |
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| Measure | Description | Time Frame |
|---|---|---|
| Cytoplasmic size increase | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Durometer reading | 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. | 6 months |
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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 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruizhi Wang | Contact | 410-502-7546 | rwang53@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Luis Garza, MD, PhD | Department of Dermatology, Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine, Dermatology Department | Recruiting | Baltimore | Maryland | 21287 | United States |
Per the requirements of the journal in which we finally publish.
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
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| C516180 | ArteFill |
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| Maryland Stem Cell Research Fund |
| UNKNOWN |
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Sites are labeled as A, B and C and masked for outcomes assessors-- but these are all in the same subject.
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| Filler Product |
| Biological |
In some select subjects the investigators will test if the addition of an FDA approved filler product Bellafill might enhance cellular efficacy. |
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