DiabetesNCT03366168
Taste Bud-Derived Stem Cells in Humans
An observational study of Diabetes, run by National Institute on Aging (NIA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2017to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
NIA Studies Recruitment, 410-350-3941, niastudiesrecruitment@mail.nih.gov
About this study
Official title: A Pilot Study of Taste Bud-Derived Stem Cells in Humans
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.
Read more
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.
- Conditions
- Diabetes
- Keywords
- Diabetes, Fungiform Papillae, Insulin, Natural History
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Ages 18-39 years | |
| Group 2 | Ages 40-59 years | |
| Group 3 | Ages 60 years old or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To demonstrate that in humans, stem cells isolated from human taste buds can be differentiated into glucose responsive insulin secreting cells
Measured: Ongoing
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.
Measured: Ongoing
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.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start18 Dec 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Josephine M Egan, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366168
- Sponsor's protocol ID
- 999918010
- Other IDs
- 18-AG-N010
- Status last verified
- 21 Oct 2026
- First submitted
- 7 Dec 2017
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study and no data/samples will be shared.
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Taste Bud-Derived Stem Cells in Humans
- ClinicalTrials.gov ID
- NCT03366168
- Acronym / sponsor ID
- 999918010
- Conditions
- Diabetes
- Keywords
- Diabetes, Fungiform Papillae, Insulin, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Ages 18-39 years |
| Group 2 | – | –Ages 40-59 years |
| Group 3 | – | –Ages 60 years old or older |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To demonstrate that in humans, epithelial stem cells isolated from the base of human taste buds can be propagated.
Time frame: Pilot Study
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.
3 secondary outcomes
To demonstrate that in humans, stem cells isolated from human taste buds can be differentiated into glucose responsive insulin secreting cells
Time frame: Ongoing
To quantify stem cell numbers and propagation rates as a factor of age.
Time frame: Ongoing
To investigate if differentiation capability of the stem cells changes as a factor of age.
Time frame: Ongoing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 38145006Yao 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.
- Individual participant dataSharing planned: No. This is a pilot study and no data/samples will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josephine M Egan, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise L Melvin, R.N. ((410) 350-3924, melvinde@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that in humans, epithelial stem cells isolated from the base of human taste buds can be propagated. (time frame: Pilot Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03366168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.