Taste Bud-Derived Stem Cells in Humans
ConditionDiabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorNational Institute on Aging (NIA)
About this trial
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
...
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years and older
Healthy (see
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 3 trial groupsGroup A: Group 1
Group B: Group 2
Group C: Group 3
Trial outcomes
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 StudySecondary 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
Ongoing2
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
Ongoing3
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
OngoingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov