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Taste Bud-Derived Stem Cells in Humans

A Pilot Study of Taste Bud-Derived Stem Cells in Humans

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03366168
Enrollment
250
Registered
2017-12-08
Start date
2017-12-18
Completion date
2026-12-31
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Fungiform Papillae, Insulin, Natural History

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 cells that secrete insulin. Taste buds are found mostly on the tip and sides of the tongue. Researchers also want to study if the number of taste buds and stem cells decrease as people age. They will remove small pieces of tongue tissue (about the size of a pen tip). The taste buds will grow back. It is hoped that studying taste bud stem cells can lead to new diabetes treatments. Objectives: To see if stem cells from taste buds can be isolated in humans. Eligibility: Healthy adults at least 18 years old Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Tongue photograph and mouth inspection. Food coloring will be applied to the tongue. Participants will have 1 study visit. They will not eat or drink anything 8 hours before. * They will give blood and urine samples. * They will have a tongue biopsy. Vital signs will be checked. The inside of the mouth will be examined. The tongue may be cleaned. The tongue will be numbed. Five small pieces of tissue will be taken with a small scissor. Any bleeding will be blotted with cotton and should stop in minutes. * Participants will be monitored for about 30 minutes. They will get a snack or meal. * They will be told how to take care of the tongue for the rest of the day. Participants will be called a week later to see how the

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 propagated in the lab; if it is, then we wish (2) to investigate whether the stem cells can be differentiated into glucose-responsive insulin-secreting cells; (3) to investigate if the number of lingual-derived stem cells and their propagation rate are affected by age; (4) to investigate if the differentiation capability of the stem cells changes as a factor of aging. EXPERIMENTAL DESIGN AND METHODS: Ninety participants, thirty in each age group: ages 18-39 years, 40-59 years and 60 years old or older will be recruited for this pilot study. Of the thirty participants in each age group, fifteen will be men and fifteen will be women. Each eligible participant will have up to 5 fungiform papillae biopsied on the anterior part of the tongue during Visit 1. MEDICAL RELEVANCE AND EXPECTED OUTCOME: The development of this technique and its standardization to harvest these stem cells in humans is important for future therapeutic interventions, and may be an invaluable method for assessing novel cell based regenerative treatments for diabetes.

Interventions

None listed

Sponsors

National Institute on Aging (NIA)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
To demonstrate that in humans, epithelial stem cells isolated from the base of human taste buds can be propagated.Pilot StudyStem cells will be isolated from the taste buds within the fungiform papillae, propagated in vitro, and then differentiated into glucose responsive insulin secreting cells.

Secondary

MeasureTime frameDescription
To demonstrate that in humans, stem cells isolated from human taste buds can be differentiated into glucose responsive insulin secreting cellsOngoingTo demonstrate that in humans, stem cells isolated from human taste buds can be differentiated into glucose responsive insulin secreting cells
To quantify stem cell numbers and propagation rates as a factor of age.OngoingTo quantify stem cell numbers and propagation rates as a factor of age.
To investigate if differentiation capability of the stem cells changes as a factor of age.OngoingTo investigate if differentiation capability of the stem cells changes as a factor of age.

Countries

United States

Contacts

CONTACTDenise L Melvin, R.N.
melvinde@mail.nih.gov(410) 350-3924
CONTACTJosephine M Egan, M.D.
eganj@mail.nih.gov(410) 558-8414
PRINCIPAL_INVESTIGATORJosephine M Egan, M.D.

National Institute on Aging (NIA)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026