Mitigating Mitochondrial RNA Release During Aging to Control Inflammation and Senescence

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT07596615
Status
Not Yet Recruiting

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Conditions

  • Aging
  • Healthy Ageing
  • Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Skin biopsy and venous blood sampling — PROCEDURE
    A single 3-4 mm punch biopsy of forearm skin is performed under local anesthesia (lidocaine 1% with epinephrine 1:100,000) for primary dermal fibroblast isolation. Venous blood is collected by standard phlebotomy from the antecubital fossa (43 mL total volume per participant): 5 mL in SST tube for serum separation, 3 mL in EDTA tube for plasma separation, 32 mL in EDTA tubes for PBMC isolation by density gradient centrifugation, and 3 mL in Tempus Blood RNA tube for whole-blood RNA stabilization. All procedures are performed at a single visit at enrollment. Samples are processed for biospecimen-based ex vivo molecular and cellular analyses; no investigational product is administered to participants.

Study Details

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.

Key Dates

First listed
May 19, 2026
Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Young adults
    Female and male volunteers aged 18-40 years
  • Experimental: Middle-aged adults
    Female and male volunteers aged 40-60 years
  • Experimental: Elderly adults
    Female and male volunteers aged 60-90 years

Primary Outcome Measure

Age-dependent differences in cytosolic release of mitochondrial RNA (mtRNA) in primary human fibroblasts [ Time Frame: Day 1 (at enrollment) ]

Central Contacts

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