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Feasibility Study for Fibroblast Autologous Skin Grafts

Primary Purpose

Wounds and Injuries

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

autologous skin fibroblasts

About this trial

This is an interventional basic science trial for Wounds and Injuries focused on measuring healthy skin, wounds and injuries, prosthetics, amputations, dermal fibroblasts

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Johns Hopkins School of Medicine, Dermatology DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

autologous skin fibroblasts

Arm Description

we are comparing 3 injection sites in the same individual

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01964859

First Posted

October 15, 2013

Last Updated

June 8, 2023

Sponsor

Johns Hopkins University

Collaborators

National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT01964859

Brief Title

Feasibility Study for Fibroblast Autologous Skin Grafts

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 7, 2015 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), United States Department of Defense

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wounds and Injuries

Keywords

healthy skin, wounds and injuries, prosthetics, amputations, dermal fibroblasts

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study 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.

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

autologous skin fibroblasts

Arm Type

Experimental

Arm Description

we are comparing 3 injection sites in the same individual

Intervention Type

Biological

Intervention Name(s)

autologous skin fibroblasts

Primary Outcome Measure Information:

Title

Cytoplasmic size increase

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Durometer reading

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ruizhi Wang

Phone

410-502-7546

rwang53@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis Garza, MD, PhD

Organizational Affiliation

Department of Dermatology, Johns Hopkins School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins School of Medicine, Dermatology Department

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherry Leung

Phone

410-502-7546

ctrep@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Luis Garza, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Per the requirements of the journal in which we finally publish.

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Feasibility Study for Fibroblast Autologous Skin Grafts

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