Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03366168
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2017-12-07
Brief Title:
Taste Bud-Derived Stem Cells in Humans
Sponsor:
National Institute on Aging NIA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Taste Bud-Derived Stem Cells in Humans
Status:
RECRUITING
Status Verified Date:
2024-05-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-AG-N010 | None | None | None |