Taste Bud-Derived Stem Cells in Humans

NCT03366168 | Recruiting

• 2 other identifiers: 99991801018-AG-N010
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes

Keywords

Diabetes; Fungiform Papillae; Insulin; Natural History

Outcome Measures

Primary Outcomes (1)

• To demonstrate that in humans, epithelial stem cells isolated from the base of human taste buds can be propagated.

  Stem cells will be isolated from the taste buds within the fungiform papillae, propagated in vitro, and then differentiated into glucose responsive insulin secreting cells.

  Pilot Study

Secondary Outcomes (3)

• To demonstrate that in humans, stem cells isolated from human taste buds can be differentiated into glucose responsive insulin secreting cells

  Ongoing

• To quantify stem cell numbers and propagation rates as a factor of age.

  Ongoing

• To investigate if differentiation capability of the stem cells changes as a factor of age.

  Ongoing

Study Arms (3)

Group 1

Ages 18-39 years

Group 2

Ages 40-59 years

Group 3

Ages 60 years old or older

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

One hundred twenty participants, forty in each age group: ages 18-39 years, 40-59 years and 60 years and older will complete the pilot study. Of the forty participants in each age group, twenty will be men and twenty will be women.

You may qualify if:

• Age 18 years and older

You may not qualify if:

• Are able to understand the study risks and procedures, and consent to participate in the study.
• Are able to read and speak English.
• 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).

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

Related Publications (1)

• Yao Q, Doyle ME, Liu QR, Appleton A, O'Connell JF, Weng NP, Egan JM. Long-Term Dysfunction of Taste Papillae in SARS-CoV-2. NEJM Evid. 2023 Sep;2(9):10.1056/evidoa2300046. doi: 10.1056/evidoa2300046. Epub 2023 Jul 20.

  PMID: 38145006 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Josephine M Egan, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise L Melvin, R.N.

CONTACT

(410) 350-3924; melvinde@mail.nih.gov

Josephine M Egan, M.D.

CONTACT

(410) 558-8414; eganj@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 8, 2017
• Study Start: December 18, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2026

Record last verified: 2025-12-16

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)