Eligibility Details:
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 2
weeks 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, antibiotics,
antimycotics, dimethyl sulfoxide, human albumin, or bovine constituents, or hetastarch
- Specifically: subjects allergic to penicillin, streptomycin, amphotericin will be
excluded in addition to those listed above.
- 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, 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
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
