Not Yet RecruitingNot Applicable

Mitigating Mitochondrial RNA Release During Aging to Control Inflammation and Senescence

Italy90 participantsStarted 2026-09

Plain-language summary

The MIRACLE study aims to investigate age-related mitochondrial dysfunction, mitochondrial RNA (mtRNA) release, inflammation, and cellular senescence in adult participants across three age groups. Skin-derived fibroblasts and peripheral blood mononuclear cells (PBMCs) will be isolated from skin biopsy and blood samples to characterize age-related cellular and molecular changes and to test experimental therapeutic strategies identified in preclinical studies. Serum, plasma, and whole-blood RNA will be used for protocol-defined analyses of circulating inflammatory mediators and systemic transcriptional signatures related to inflammation, type I interferon activation, mitochondrial stress response, immune aging, and senescence-associated pathways.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female * Age between 18 and 90 years (stratified in three groups: young, middle-aged, elderly) * Written informed consent Exclusion Criteria: * Inability to understand the potential risk and benefits of the study * Legal incapacity * Subjects who have taken antibiotics, anti-inflammatory drugs, or antihistamines within the past 7 days * Diagnosis of diabetes mellitus * Use of anticoagulant medications * Any subject with a contraindication to the mini-invasive biopsy procedure

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Age-dependent differences in cytosolic release of mitochondrial RNA (mtRNA) in primary human fibroblasts

Timeframe: Day 1 (at enrollment)

Age-dependent differences in mitochondrial function in primary human fibroblasts

Timeframe: Day 1 (at enrollment)

Activation of inflammatory pathways in primary human fibroblasts

Timeframe: Day 1 (at enrollment)

Activation of senescence pathways in primary human fibroblasts

Timeframe: Day 1 (at enrollment)

Comparison of fibroblast findings with PBMC-derived parameters from the same participants

Timeframe: Day 1 (at enrollment)

Trial details

NCT IDNCT07596615

SponsorMario Negri Institute for Pharmacological Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-09

Contact for this trial

Luca Perico, PhD

+3903542131 luca.perico@marionegri.it

View on ClinicalTrials.gov More Aging trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Age-dependent differences in cytosolic release of mitochondrial RNA (mtRNA) in primary human fibroblasts

Timeframe: Day 1 (at enrollment)

Age-dependent differences in mitochondrial function in primary human fibroblasts

Timeframe: Day 1 (at enrollment)

Activation of inflammatory pathways in primary human fibroblasts

Timeframe: Day 1 (at enrollment)

Activation of senescence pathways in primary human fibroblasts

Timeframe: Day 1 (at enrollment)

Comparison of fibroblast findings with PBMC-derived parameters from the same participants

Timeframe: Day 1 (at enrollment)