RECRUITING

Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

Conditions

Amputation Skin Wound Stem Cell stem cells autologous fibroblast skin breakdown

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

Quick Facts

Study Start:2019-09-05

Study Completion:2028-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03947450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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 * 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.)

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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
* 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.)

Contacts and Locations

Study Contact

Ruizhi Wang, MPhil

CONTACT

410-502-7546

rwang53@jhmi.edu

Erika Dare, CRNP

CONTACT

410-502-7546

edare1@jhmi.edu

Principal Investigator

Luis Garza, MD PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Department of Dermatology at Johns Hopkins University

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Luis Garza, MD PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-05

Study Completion Date2028-04-01

Study Record Updates

Study Start Date2019-09-05

Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

amputation
stem cells
autologous fibroblast
skin wound
skin breakdown

Additional Relevant MeSH Terms

Amputation
Skin Wound
Stem Cell