ClinicalTrials.gg
RecruitingNCT03366168Updated Oct 26, 2026

Taste Bud-Derived Stem Cells in Humans

An observational study in Diabetes, sponsored by National Institute on Aging (NIA). Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by National Institute on Aging (NIA) · Observational

From the registry’s dates

  • Started Dec 2017; still recruiting 8 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
250
Ages
18 Years to 120 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Diabetes Mellitus by National Institute on Aging (NIA) — 1 open to participants now, 2 under way, none of them phase 3. Diabetes Mellitus · National Institute on Aging (NIA).

Started
2017
the only one that year
Observational
6 of 10
1 open now
Registered
10th of 10
by date

Among the 10 studies in Diabetes Mellitus by National Institute on Aging (NIA), this one is the only one that started in 2017, is one of 6 observational ones, and was the 10th registered.

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

Browse Diabetes Mellitus studies →

Open to participants now

1 of the 10 studies in Diabetes Mellitus by National Institute on Aging (NIA) is open now, in 1 country.

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.

This study: 18 Years to 120 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Diabetes Mellitus by National Institute on Aging (NIA), or all of them as a file.
02

Study 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

Read 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.

03

Conditions studied

  • Diabetes

Keywords

  • Diabetes
  • Fungiform Papillae
  • Insulin
  • Natural History
04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 , other than ocular within 30 days of their scheduled biopsy procedure.
  • virus infection.
  • or C.
  • Kidney disease (Creatinine greater than1.5 mg/dl or calculated less than 50 cc/min).
  • Liver disease (, 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 (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.).
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
250 participants (estimated)

Groups and cohorts

  • Group 1

    Ages 18-39 years

  • Group 2

    Ages 40-59 years

  • Group 3

    Ages 60 years old or older

06

What researchers measure

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.

    Time frame: Pilot Study

Secondary outcomes

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

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

    Time frame: Ongoing

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

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

    Time frame: Ongoing

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

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

    Time frame: Ongoing

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 38145006 ↗

Individual participant data

Plan to share: No — This is a pilot study and no data/samples will be shared.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2017 (actual). Primary completion is estimated for Dec 2026, 108 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2017
First posted
Dec 8, 2017
StartActual
Dec 18, 2017
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03366168
Responsible party
Sponsor
First posted
Dec 8, 2017
Start date
Dec 18, 2017
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 26, 2026

Study contacts

Denise L Melvin, R.N.
Contact
melvinde@mail.nih.gov
(410) 350-3924
Josephine M Egan, M.D.
Contact
eganj@mail.nih.gov
(410) 558-8414
Josephine M Egan, M.D.
principal investigator · National Institute on Aging (NIA)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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