Healthy VolunteersNCT02755584
Study of Skin Cells That Stop Replicating (Senescent) During Wound Healing
An observational study of Healthy Volunteers, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
Background: Cellular senescence is the aging of cells. It is a complex process that may be connected with aging and age-related diseases. It is unknown if these cells appear around wound sites in humans a few days after skin injury and if there are differences in young and old individuals. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Healthy Volunteers
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes healthy volunteers between the ages of 20-39 years and 70 years old and older. Each age group will be men and women Caucasian and African American.
Who may be able to join
- Age 20 - 39 years or age 70 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.
- Caucasian or African American
- Previous enrolled participants.
Who cannot join
- 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.
- A medical condition that causes impaired wound healing such as diabetes.
- Current androgenic/anabolic and/or corticosteroid use or use within 90 days of the procedure (ocular corticosteroid use okay).
- Current antibiotic or anti-viral use or use within 60 days of the procedure.
- Active infections or chronic skin conditions that would prevent access to the biopsy area.
Show all 24Show fewer
- 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 3 days before the biopsy and 1 day after the biopsy procedure.
- Taking more than 81 mg of aspirin a day and the participant is unable to stop taking it for 3 days before the biopsy and 1 day 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.
- Allergic to topical betadine solution.
- Severe allergy to adhesives found in tape.
- HIV virus infection.
- Hepatitis B or C or exposure within 6 months of visit.
- History of diabetes (requiring any medical treatment other than diet and exercise) or fasting plasma glucose is >=126 mg/dL or HbA1c >= 6.5%.
- Clinically significant hormonal dysfunction (self-reported or laboratory values out of range. Mild hypothyroidism (TSH < 10 microIU/mL) in participants over 60 is not considered exclusion).
- Kidney disease (Creatinine >1.5 mg/dl or calculated creatinine clearance < 50 cc/min)
- Liver disease (Bilirubin > 1.5 mg/dl (unless higher levels can be ascribed to Gilbert s 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 severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment.
- Currently pregnant or breastfeeding.
- Participants with history of skin keloid formation during wound healing
- Current illness that as judged by the study physician substantially increases the risks associated the skin biopsy(s) (active infections, allergies, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
Official title: A Pilot Study of Skin Cells That Stop Replicating (Senescent) During Wound Healing
Background:
Cellular senescence is the aging of cells. It is a complex process that may be connected with aging and age-related diseases. It is unknown if these cells appear around wound sites in humans a few days after skin injury and if there are differences in young and old individuals. This study is being done to look at how cells in your body respond to small skin wounds. This information may help treat age-related diseases.
Read more
Objective:
To study how cells in the body respond to small skin wounds.
Eligibility:
Healthy adults ages 20-39 or 70+
Design:
Participants will be screened with medical history, physical exam, and blood sample. They will fast before the screening visit. Women will have a urine pregnancy test.
Participants will have 3 study visits over about 3 weeks.
Visits 1 and 2: Participants will fast before and have blood taken. Women will have a urine test. All participants will have 2 skin biopsies. A spot on the upper arm will be numbed. Two small pieces of skin will be removed. They will keep the area covered until the next visit.
Visit 3: Participants will have their vital signs taken. Their biopsy wounds will be measured and photographed.
Read the detailed description
Objectives and Specific Aims:
The objective of this proof-of-concept study is to understand the physiological role of senescent cells in humans during the aging process using a model of wound healing. Cellular senescence is the phenomenon by which normal cells cease to divide in response to a stress. We aim to determine if in healthy humans: (1) senescent cells appear around wound sites a few days after skin injury; (2) the number of senescent cells induced by skin injury increases with age; (3) the wound healing process, as determined by the size of the healed wounds, is altered with aging; (4) biomarkers of senescence-associated secretory phenotype (SASP) increase significantly in the tissue around the wound a few days after skin injury, and the magnitude of increase is higher in older compared to younger persons; (5) ethnic differences in the dynamics of the appearance of senescent cells and whether such a difference is associated with wound healing. We also want to describe changes that occur with aging in DNA methylation and histone acetylation, gene expression, and protein expression within senescent cells in comparison to normal tissue.
Experimental Design and Methods:
One hundred and twenty-eight healthy participants, sixty-four between the ages of 20-39 years and sixty-four 70 years old or older will be recruited for this pilot study. Of the sixty-four participants in each age group, thirty-two will be men and thirty-two will be women and sixteen
will be Caucasian and sixteen will be African American. Each participant will have two 3mm skin biopsies on the inner upper arm during baseline visit (Visit 1) and two 6mm skin biopsies concentric to the previous site during Visit 2. Visit 2 will be scheduled on 8 different days (day 3, 5, 7, 9, 11, 13, 21 and 30) after the baseline visit with two men and two woman from each age/ethnic group for each of the days. A follow-up visit will be scheduled at the discretion of the medical staff. Senescent cells will be visualized by confocal microscopy based on a number of senescent markers described in the literature. Senescent biomarkers will be measured in the tissue and systemically at baseline and follow-up.
Medical Relevance and Expected Outcome:
Cellular senescence is a complex process characterized by arrest in replication that is thought to be intrinsically connected with aging and age-related diseases. Recently, researchers have
suggested that senescent cells may play a role in the pathogenesis of type 2 diabetes and its associated complications. Therefore, understanding the physiological role of senescent cells is critically important for understanding aging and age-related diseases such as type 2 diabetes. Preclinical data have shown that senescent cells were inducible during cutaneous wound healing. Our preliminary results showed that there may be a difference in rate of granulation tissue formation with ethnicity. Therefore, this method can be used to quantify
senescent cell response after a standard stimulus and to verify whether the magnitude of senescence response correlate with aging and ethnicity. In the future this method could be used to test interventions that can modify the senescence response, and may be an invaluable method for assessing novel treatments of type 2 diabetes involving senescent cells.
- Conditions
- Healthy Volunteers
- Keywords
- Aging, Senescent Cells, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | between the ages of 20-39 years and 70 years old and older |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that in humans, senescent cells will appear around wound sites after skin injury.
Understanding the physiological role of senescent cells is critically important for understanding aging and age related diseases. Our preliminary results showed that there may be a difference in rate of granulation tissue formation with ethnicity.
Measured: Basline visit 1and visit 2 six different days
Secondary outcomes (1)
The number of senescent cells induced by skin injury increases with age. The wound healing process, as determined by the size of the healed wounds, may be associated with aging.
The number of senescent cells induced by skin injury increases with age. The wound healing process, as determined by the size of the healed wounds, may be associated with aging.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start30 Jun 2016
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Chee W Chia, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755584
- Sponsor's protocol ID
- 999916101
- Other IDs
- 16-AG-N101
- Status last verified
- 24 Feb 2026
- First submitted
- 28 Apr 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The NIA IRP is discussing the plan to make IPD available. A final decision has not been made.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Skin Cells That Stop Replicating (Senescent) During Wound Healing
- ClinicalTrials.gov ID
- NCT02755584
- Acronym / sponsor ID
- 999916101
- Conditions
- Healthy Volunteers
- Keywords
- Aging, Senescent Cells, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Cellular senescence is the aging of cells. It is a complex process that may be connected with aging and age-related diseases. It is unknown if these cells appear around wound sites in humans a few days after skin injury and if there are differences in young and old individuals. This study is being done to look at how cells in your body respond to small skin wounds. This information may help treat age-related diseases.
Objective:
To study how cells in the body respond to small skin wounds.
Eligibility:
Healthy adults ages 20-39 or 70+
Design:
Participants will be screened with medical history, physical exam, and blood sample. They will fast before the screening visit. Women will have a urine pregnancy test.
Participants will have 3 study visits over about 3 weeks.
Visits 1 and 2: Participants will fast before and have blood taken. Women will have a urine test. All participants will have 2 skin biopsies. A spot on the upper arm will be numbed. Two small pieces of skin will be removed. They will keep the area covered until the next visit.
Visit 3: Participants will have their vital signs taken. Their biopsy wounds will be measured and photographed.
Detailed description
Objectives and Specific Aims:
The objective of this proof-of-concept study is to understand the physiological role of senescent cells in humans during the aging process using a model of wound healing. Cellular senescence is the phenomenon by which normal cells cease to divide in response to a stress. We aim to determine if in healthy humans: (1) senescent cells appear around wound sites a few days after skin injury; (2) the number of senescent cells induced by skin injury increases with age; (3) the wound healing process, as determined by the size of the healed wounds, is altered with aging; (4) biomarkers of senescence-associated secretory phenotype (SASP) increase significantly in the tissue around the wound a few days after skin injury, and the magnitude of increase is higher in older compared to younger persons; (5) ethnic differences in the dynamics of the appearance of senescent cells and whether such a difference is associated with wound healing. We also want to describe changes that occur with aging in DNA methylation and histone acetylation, gene expression, and protein expression within senescent cells in comparison to normal tissue.
Experimental Design and Methods:
One hundred and twenty-eight healthy participants, sixty-four between the ages of 20-39 years and sixty-four 70 years old or older will be recruited for this pilot study. Of the sixty-four participants in each age group, thirty-two will be men and thirty-two will be women and sixteen
will be Caucasian and sixteen will be African American. Each participant will have two 3mm skin biopsies on the inner upper arm during baseline visit (Visit 1) and two 6mm skin biopsies concentric to the previous site during Visit 2. Visit 2 will be scheduled on 8 different days (day 3, 5, 7, 9, 11, 13, 21 and 30) after the baseline visit with two men and two woman from each age/ethnic group for each of the days. A follow-up visit will be scheduled at the discretion of the medical staff. Senescent cells will be visualized by confocal microscopy based on a number of senescent markers described in the literature. Senescent biomarkers will be measured in the tissue and systemically at baseline and follow-up.
Medical Relevance and Expected Outcome:
Cellular senescence is a complex process characterized by arrest in replication that is thought to be intrinsically connected with aging and age-related diseases. Recently, researchers have
suggested that senescent cells may play a role in the pathogenesis of type 2 diabetes and its associated complications. Therefore, understanding the physiological role of senescent cells is critically important for understanding aging and age-related diseases such as type 2 diabetes. Preclinical data have shown that senescent cells were inducible during cutaneous wound healing. Our preliminary results showed that there may be a difference in rate of granulation tissue formation with ethnicity. Therefore, this method can be used to quantify
senescent cell response after a standard stimulus and to verify whether the magnitude of senescence response correlate with aging and ethnicity. In the future this method could be used to test interventions that can modify the senescence response, and may be an invaluable method for assessing novel treatments of type 2 diabetes involving senescent cells.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –between the ages of 20-39 years and 70 years old and older |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes healthy volunteers between the ages of 20-39 years and 70 years old and older. Each age group will be men and women Caucasian and African American.
Key inclusion criteria (6 listed)
- Age 20 - 39 years or age 70 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.
- Caucasian or African American
Key exclusion criteria (24 listed)
- 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.
- A medical condition that causes impaired wound healing such as diabetes.
- Current androgenic/anabolic and/or corticosteroid use or use within 90 days of the procedure (ocular corticosteroid use okay).
- Current antibiotic or anti-viral use or use within 60 days of the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To demonstrate that in humans, senescent cells will appear around wound sites after skin injury.
Time frame: Basline visit 1and visit 2 six different days
Understanding the physiological role of senescent cells is critically important for understanding aging and age related diseases. Our preliminary results showed that there may be a difference in rate of granulation tissue formation with ethnicity.
1 secondary outcome
The number of senescent cells induced by skin injury increases with age. The wound healing process, as determined by the size of the healed wounds, may be associated with aging.
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided. The NIA IRP is discussing the plan to make IPD available. A final decision has not been made.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chee W Chia, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that in humans, senescent cells will appear around wound sites after skin injury. (time frame: Basline visit 1and visit 2 six different days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.