Using taste bud stem cells to explore diabetes treatment
A Pilot Study of Taste Bud-Derived Stem Cells in Humans
This study is testing if stem cells from human taste buds can help us understand diabetes treatment by looking at how these cells work and change as we age.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03366168 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the potential of stem cells derived from human taste buds to be isolated and propagated in the lab. Researchers will biopsy small samples of tongue tissue from healthy adults across different age groups to assess the number and functionality of these stem cells. The study will also explore how aging affects the quantity and differentiation capability of these cells, particularly their ability to secrete insulin in response to glucose. Participants will undergo a single study visit involving medical screening and a biopsy procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 years and older with sufficient fungiform papillae on their tongues.
Not a fit: Patients with chronic medical conditions requiring anticoagulant medications or those with insufficient taste buds will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to innovative treatments for diabetes by utilizing stem cells to produce insulin-secreting cells.
How similar studies have performed: While the use of taste bud-derived stem cells is a novel approach, similar studies exploring stem cells for diabetes treatment have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Baltimore, Maryland
- National Institute of Aging, Clinical Research Unit — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Josephine M Egan, M.D. — National Institute on Aging (NIA)
- Study coordinator: Denise L Melvin, R.N.
- Email: melvinde@mail.nih.gov
- Phone: (410) 350-3924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.