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New treatment option for Wounds and Injuries
Official title Feasibility Study for Fibroblast Autologous Skin Grafts
ClinicalTrials.gov ID: NCT01964859
What this study is testing
What is autologous skin fibroblasts?
autologous skin fibroblasts is an investigational medicine, being studied as a potential treatment for wounds and injuries.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Be able to comprehend the informed consent document and provide consent for participation
- Females of childbearing potential must:
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.