Status:
RECRUITING
Taste Bud-Derived Stem Cells in Humans
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Diabetes
Eligibility:
All Genders
18-120 years
Brief Summary
Background: Stem cells are found in body tissues. They can regenerate into more of the same cells or become other types of cell. Researchers want to use stem cells from taste buds to try to make cell...
Detailed Description
OBJECTIVES AND SPECIFIC AIMS: The objectives of this proof-of-concept study are: (1) to investigate whether stem cells, normally present in tongue epithelium at the base of taste buds, can be propaga...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18 years and older
- Healthy (see exclusion criteria below)
- Are able to understand the study risks and procedures, and consent to participate in the study.
- Are able to read and speak English.
- EXCLUSION CRITERIA:
- Have less than 40 fungiform papillae on the anterior third portion of the tongue as evidenced by tongue photo taken during the screen visit.
- Does not agree to the use of their tissue samples to produce stem cells.
- A medical condition that requires the use of chronic anticoagulant medication use such as warfarin, clopidogrel, heparin or antiplatelet agents other than low dose aspirin (81mg).
- History of increased bleeding due to either a known medical condition or an undiagnosed cause.
- Active infections or chronic conditions that would prevent access to the biopsy area.
- Taking non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen) and the participant is unable to stop taking them 4 days before and 3 days after the final biopsy procedure.
- Taking more than 81 mg of aspirin a day and the participant is unable to stop taking it for 4 days before and 3 days after the biopsy procedure.
- Allergic to Lidocaine (Xylocaine) or any other local anesthetic or the participant has had in the past a severe allergic reaction to similar drugs.
- Have taken steroids, other than ocular within 30 days of their scheduled biopsy procedure.
- HIV virus infection.
- Hepatitis B or C.
- Kidney disease (Creatinine greater than1.5 mg/dl or calculated creatinine clearance less than 50 cc/min).
- Liver disease (ALT, AST or alkaline phosphatase twice the normal serum concentration).
- Severe gastrointestinal diseases such as Crohn s disease or ulcerative colitis requiring continuous treatment.
- History of severe pulmonary disease such as chronic obstructive pulmonary disease (COPD) or asthma requiring continuous medication use.
- History of using any tobacco products within the past six months.
- History of severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment.
- Currently pregnant or breastfeeding.
- Current illness that as judged by the study physician substantially increases the risks associated with the tongue biopsy (active infections, allergies, etc.).
Exclusion
Key Trial Info
Start Date :
December 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03366168
Start Date
December 18 2017
End Date
December 31 2025
Last Update
December 19 2025
Active Locations (1)
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1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224