Taste Bud-Derived Stem Cells in Humans
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|ClinicalTrials.gov Identifier: NCT03366168|
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : July 9, 2019
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.
To see if stem cells from taste buds can be isolated in humans.
Healthy adults at least 18 years old
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
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||A Pilot Study of Taste Bud-Derived Stem Cells in Humans|
|Actual Study Start Date :||October 27, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Group 1 - 18-39 years
thirty participants between the ages 18-39 years. Of the thirty participants, fifteen will be men and fifteen will be women.
Group 2 - 40-59 years
thirty participants between the ages 40-59 years. Of the thirty participants, fifteen will be men and fifteen will be women.
Group 3 - 60 years and older
thirty participants ages 60 years and older. Of the thirty participants, fifteen will be men and fifteen will be women.
- To demonstrate that in humans, epithelial stem cells isolated from the base of human taste buds can be propagated. [ Time Frame: Ongoing ]
- To demonstrate that in humans, stem cells isolated from human taste buds can differentiated into glucose responsive insulin seceting 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366168
|Contact: Denise L Melvin, R.N.||(410) firstname.lastname@example.org|
|United States, Maryland|
|National Institute of Aging, Clinical Research Unit||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Josephine M Egan, M.D.||National Institute on Aging (NIA)|