Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Taste Bud-Derived Stem Cells in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03366168
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

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


Condition or disease
Diabetes

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Pilot Study of Taste Bud-Derived Stem Cells in Humans
Estimated Study Start Date : April 26, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. To demonstrate that in humans, epithelial stem cells isolated from the base of human taste buds can be propagated. [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. To demonstrate that in humans, stem cells isolated from human taste buds can differentiated into glucose responsive insulin seceting cells [ Time Frame: Ongoing ]
  2. 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. [ Time Frame: Ongoing ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ninety healthy participants, fifteen men and fifteen women in each age group: (1)ages 18-39 years, (2)40-59 years and (3)60 years and older.
Criteria
  • 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:

  • 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.
  • 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.).

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Denise L Melvin, R.N. (410) 350-3924 dm381j@nih.gov

Locations
Layout table for location information
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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Josephine M Egan, M.D. National Institute on Aging (NIA)

Publications:
Layout table for additonal information
Responsible Party: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT03366168     History of Changes
Other Study ID Numbers: 999918010
18-AG-N010
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: September 21, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ):
Diabetes
Fungiform Papillae
Insulin