AmputationPhase 2NCT03947450
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
A Phase 2 study testing Autologous Skin Fibroblasts in people with Amputation and Skin Wound, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Skin Wound, Stem Cell
- What is being tested?
- Autologous Skin Fibroblasts
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 1 Apr 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
- Patients interested in study participation must meet all of the following inclusion criteria:
- May be male or female
- Must be between 18 years and 65 years of age
- Must have a below the knee amputation.
- Must be using a prosthetic for the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month.
- 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.
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- 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
- 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
- Patients meeting any of the following criteria will be ineligible for study participation:
- A skin erosion deeper than the skin dermis.
- 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, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%).
- Pregnant, lactating, or trying to become pregnant
- A history of keloid formation
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- 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, 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.
- Presence of necrotic ischemic tissue on any stump ulcers, and/or capillary refill on stump skin of greater than 3 seconds
- Active infection of the residual limb.
- 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.
- Recent amputee who has not yet been approved to use a prosthetic.
- Use of a prosthetic for less than 3 months.
- Amputees with neuromas of the terminal limb within the last 3 months.
- Known bleeding disorder.
- For those receiving Bellafill/collagen skin test: history of serious allergy, such as anaphylaxis.
- For whole stump injections: Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen, Acetanilid, Aniline dyes, Benzocaine, Chloroquine, Dapsone, Naphthalene, Nitrates and Nitrites, Nitrofurantoin, Nitroglycerin, Nitroprusside, Pamaquine, Para-aminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.)
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
Department of Dermatology at Johns Hopkins University
Baltimore, Maryland, 21287
Ruizhi Wang, 410-502-7546, Rwang53@jhmi.edu
Erika Dare, CRNP, 410-502-7546, edare1@jhmi.edu
About this study
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
Read the detailed description
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
The investigators have demonstrated that injection of fibroblasts (from the palm or sole) is safe in healthy adults and potentially enhances palm or sole features in skin cells in areas other than the palm and sole. In a prior study, healthy adults injected with fibroblasts (from the palm or sole) experienced more firm skin at the injection site.
The objective of this study is to determine if fibroblast (from palm or sole) injections are safe and effective at increasing epidermal thickness and skin firmness at the stump site in below the knee amputees. Outcomes are assessed via questionnaires, non-invasive imaging devices, and non-invasive skin firmness measuring devices.
Injections will be targeted to the entire stump (unless determined otherwise by the PI and participant), including pressure intolerant areas of the skin that come into contact with the prosthetic socket, a region that is prone to skin irritation and breakdown, We will evaluate the most effective approach to administering this intervention via injections to the entire stump and the safety and effectiveness of whole stump injections and their effects on prosthesis use, skin breakdown, quality of life, and activity level.
The investigators hope that information from this study will help with problems like skin breakdown in patients with amputations and prosthetics. The skin at the 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.
- Conditions
- Amputation, Skin Wound, Stem Cell
- Being tested
- Autologous Skin Fibroblasts, Placebo
- Keywords
- amputation, stem cells, autologous fibroblast, skin wound, skin breakdown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Skin FibroblastsBiological
The site or whole stump will be injected with autologous fibroblasts
PlaceboBiological
The site or whole stump will be injected medium only without autologous skin fibroblasts
| Study group | Role | What they receive |
|---|---|---|
| Autologous skin fibroblasts | Experimental | For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives autologous skin fibroblast whole stump injections.
For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives autologous skin fibroblasts. Receives: Biological: Autologous Skin Fibroblasts |
| Control | Placebo comparator | For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives vehicle (placebo) whole stump injections.
For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives a placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by number of hospitalizations
To determine the safety of the use of autologous volar fibroblasts to reprogram non-volar to volar-like epidermis with larger cytoplasmic area in human participants. The investigators will measure the numbers of hospitalizations which are related to the study. The occurrence of any study related hospitalization will be counted as one.
Measured: 12 months
Secondary outcomes (1)
Change in amount of skin breakdown as assessed by ulceration measurement
Skin breakdown as assessed by ulceration measurement: The investigators will measure areas of skin breakdown on the terminal limb to see if the areas injected with volar fibroblasts have influenced skin healing. The unit of measurement is in millimeters. Pre and post cell-injection measurements will be compared.
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start5 Sep 2019
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single arm crossover, subjects will be randomized 1:1 into whole stump injections of volar fibroblasts and vehicle injections respectively. Subjects will be blinded to which injections they will receive. At the end of the study, subjects who received vehicle injections will be notified and offered whole stump volar fibroblast injections. Blinding will occur for research staff both during measurements of epidermal thickness/area. If the PI or subject determines that they do not qualify for whole stump injection, do not desire whole stump injection, or are already enrolled as localized stump injections- the study will continue as a parallel interventional study model in which 2 locations are selected for fibroblast and vehicle injections on the same subject. Subjects who receive localized injections will be offered whole stump fibroblast injection at the end of the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Stem Cell Research Fund, United States Department of Defense, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Luis Garza, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947450
- Sponsor's protocol ID
- IRB00192461
- Other IDs
- W81XWH-18-2-0055
- Status last verified
- Jun 2026
- First submitted
- 9 May 2019
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tsai J, Rostom M, Garza LA. Understanding and Harnessing Epithelial-Mesenchymal Interactions in the Development of Palmoplantar Identity. J Invest Dermatol. 2022 Feb;142(2):282-284. doi: 10.1016/j.jid.2021.06.016. Epub 2021 Aug 6.
PubMed 34366107
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
- Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
- ClinicalTrials.gov ID
- NCT03947450
- Acronym / sponsor ID
- IRB00192461
- Conditions
- Amputation, Skin Wound, Stem Cell
- Keywords
- amputation, stem cells, autologous fibroblast, skin wound, skin breakdown
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Maryland Stem Cell Research Fund, United States Department of Defense, National Institutes of Health (NIH)
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 13 May 2019 (actual)
- 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 study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
Detailed description
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
The investigators have demonstrated that injection of fibroblasts (from the palm or sole) is safe in healthy adults and potentially enhances palm or sole features in skin cells in areas other than the palm and sole. In a prior study, healthy adults injected with fibroblasts (from the palm or sole) experienced more firm skin at the injection site.
The objective of this study is to determine if fibroblast (from palm or sole) injections are safe and effective at increasing epidermal thickness and skin firmness at the stump site in below the knee amputees. Outcomes are assessed via questionnaires, non-invasive imaging devices, and non-invasive skin firmness measuring devices.
Injections will be targeted to the entire stump (unless determined otherwise by the PI and participant), including pressure intolerant areas of the skin that come into contact with the prosthetic socket, a region that is prone to skin irritation and breakdown, We will evaluate the most effective approach to administering this intervention via injections to the entire stump and the safety and effectiveness of whole stump injections and their effects on prosthesis use, skin breakdown, quality of life, and activity level.
The investigators hope that information from this study will help with problems like skin breakdown in patients with amputations and prosthetics. The skin at the 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single arm crossover, subjects will be randomized 1:1 into whole stump injections of volar fibroblasts and vehicle injections respectively. Subjects will be blinded to which injections they will receive. At the end of the study, subjects who received vehicle injections will be notified and offered whole stump volar fibroblast injections. Blinding will occur for research staff both during measurements of epidermal thickness/area. If the PI or subject determines that they do not qualify for whole stump injection, do not desire whole stump injection, or are already enrolled as localized stump injections- the study will continue as a parallel interventional study model in which 2 locations are selected for fibroblast and vehicle injections on the same subject. Subjects who receive localized injections will be offered whole stump fibroblast injection at the end of the study.
| Arm | Type | Receives |
|---|---|---|
| Autologous skin fibroblasts | Experimental | Biological: Autologous Skin FibroblastsFor whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives autologous skin fibroblast whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives autologous skin fibroblasts. |
| Control | Placebo comparator | Biological: PlaceboFor whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives vehicle (placebo) whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives a placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients interested in study participation must meet all of the following inclusion criteria:
- May be male or female
- Must be between 18 years and 65 years of age
- Must have a below the knee amputation.
- Must be using a prosthetic for the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month.
Key exclusion criteria (18 listed)
- Patients meeting any of the following criteria will be ineligible for study participation:
- A skin erosion deeper than the skin dermis.
- 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, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%).
- Pregnant, lactating, or trying to become pregnant
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 FibroblastsThe site or whole stump will be injected with autologous fibroblasts | Biological | Autologous skin fibroblasts |
| PlaceboThe site or whole stump will be injected medium only without autologous skin fibroblasts | Biological | Control |
Primary outcome
Safety as assessed by number of hospitalizations
Time frame: 12 months
To determine the safety of the use of autologous volar fibroblasts to reprogram non-volar to volar-like epidermis with larger cytoplasmic area in human participants. The investigators will measure the numbers of hospitalizations which are related to the study. The occurrence of any study related hospitalization will be counted as one.
1 secondary outcome
Change in amount of skin breakdown as assessed by ulceration measurement
Time frame: Baseline, 1 month
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.
- Derived from this study: PubMed 34366107Tsai J, Rostom M, Garza LA. Understanding and Harnessing Epithelial-Mesenchymal Interactions in the Development of Palmoplantar Identity. J Invest Dermatol. 2022 Feb;142(2):282-284. doi: 10.1016/j.jid.2021.06.016. Epub 2021 Aug 6.
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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
Johns Hopkins University
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 in people with Amputation and Skin Wound, 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 12 inclusion and 18 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. Some participants in this study may receive a placebo. 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, MPhil (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?
Safety as assessed by number of hospitalizations (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03947450, which also lists 1 linked publication.
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.