Wounds and InjuriesPhase 2NCT01964859
Feasibility Study for Fibroblast Autologous Skin Grafts
A Phase 2 study testing autologous skin fibroblasts and Filler Product in people with Wounds and Injuries, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- autologous skin fibroblasts and Filler Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2015to 1 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine, Dermatology Department
Baltimore, Maryland, 21287
Sherry Leung, 410-502-7546, ctrep@jhmi.edu
Luis Garza, MD, PhD
About this study
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.
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.
Read the 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.
- Conditions
- Wounds and Injuries
- Being tested
- autologous skin fibroblasts, Filler Product
- Keywords
- healthy skin, wounds and injuries, prosthetics, amputations, dermal fibroblasts
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous skin fibroblastsBiological
autologous skin fibroblasts
Filler ProductBiological
Also called Bellafill
In some select subjects the investigators will test if the addition of an FDA approved filler product Bellafill might enhance cellular efficacy.
| Study group | Role | What they receive |
|---|---|---|
| autologous skin fibroblasts | Experimental | The investigators are comparing 3 injection sites in the same individual Receives: Biological: autologous skin fibroblasts; Biological: Filler Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study start7 Jan 2015
- Primary completion2 Dec 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), United States Department of Defense, Maryland Stem Cell Research Fund
- Responsible party
- Sponsor
- Investigators
- Luis Garza, MD, PhD, Principal investigator, Department of Dermatology, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964859
- Sponsor's protocol ID
- NA_00068684
- Other IDs
- 1R01AR064297-01A1
- Status last verified
- Jun 2026
- First submitted
- 15 Oct 2013
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Per the requirements of the journal in which we finally publish.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01964859
- Acronym / sponsor ID
- NA_00068684
- Conditions
- Wounds and Injuries
- Keywords
- healthy skin, wounds and injuries, prosthetics, amputations, dermal fibroblasts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), United States Department of Defense, Maryland Stem Cell Research Fund
- Study start
- 7 Jan 2015 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous skin fibroblasts | Experimental | Biological: autologous skin fibroblasts, Biological: Filler ProductThe investigators are comparing 3 injection sites in the same individual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous skin fibroblastsautologous skin fibroblasts | Biological | autologous skin fibroblasts |
| Filler ProductAlso: BellafillIn some select subjects the investigators will test if the addition of an FDA approved filler product Bellafill might enhance cellular efficacy. | Biological | autologous skin fibroblasts |
Primary outcome
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.
1 secondary outcome
Durometer reading
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. Per the requirements of the journal in which we finally publish.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis Garza, MD, PhD principal investigator
Department of Dermatology, Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous skin fibroblasts and Filler Product in people with Wounds and Injuries, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruizhi Wang (410-502-7546, rwang53@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytoplasmic size increase (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.