- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07596615
Mitigating Mitochondrial RNA Release During Aging to Control Inflammation and Senescence (MIRACLE)
Mitigating Mitochondrial RNA Release During Aging to Control Inflammation and Senescence, Preserving Organ Function and Enhancing Healthspan
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Mitochondria are crucial for ATP production and intracellular signaling in higher eukaryotic cells. These organelles contain genetic material that reflects their bacterial ancestry, including mitochondrial RNA (mtRNA). Under normal conditions, mtRNA is tightly confined and processed within mitochondria, ensuring the proper synthesis of proteins required for oxidative phosphorylation. Recent evidence suggests that mitochondrial stress may promote the leakage of mitochondrial components, including mtRNA. Once released into the cytosol, mtRNA can be sensed by cytosolic pattern recognition receptors (PRRs), thereby activating signaling pathways that promote the production of pro-inflammatory cytokines.
Although these mechanisms have been investigated mainly under conditions of acute stress, the specific contribution of mitochondrial dysfunction and mtRNA release to chronic low-grade inflammation and cellular senescence during physiological aging remains incompletely understood. This represents an important knowledge gap in the understanding of molecular processes that may contribute to age-related inflammation and functional decline.
The MIRACLE project includes a broade series of preclinical in vitro and in vivo experiments aimed at clarifying the mechanisms linking mitochondrial dysfunction, mtRNA release, inflammatory pathway activation, and cellular senescence during aging. These experimental activities are designed to define the biological pathways involved and to identify potential strategies capable of modulating mtRNA-associated inflammatory and senescence responses.
Within this broader framework, the present human study is intended to corroborate and extend the preclinical findings in humans. To this aim, adult participants across different age groups will be enrolled, and skin biopsy and blood samples will be collected to obtain skin-derived fibroblasts, peripheral blood mononuclear cells (PBMCs), serum, plasma, and whole-blood RNA.
Skin-derived fibroblasts will provide an accessible primary cell model for the investigation of age-related cellular and molecular changes. Fibroblasts isolated from participants of different ages will be used to assess mitochondrial function, mtRNA release, inflammatory signaling, and markers of cellular senescence. PBMCs collected from the same participants will be analyzed as a complementary blood-derived cellular model to evaluate systemic immune and inflammatory features, including immunosenescence-related signatures. Serum and plasma samples will be used to measure circulating inflammatory mediators and senescence-associated factors, while whole-blood RNA will be used to assess systemic transcriptional signatures related to inflammation, type I interferon activation, mitochondrial stress response, immune aging, and senescence-associated pathways.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Luca Perico, PhD
- Telefonní číslo: +3903542131
- E-mail: luca.perico@marionegri.it
Studijní záloha kontaktů
- Jméno: Miriam Rigoldi, MD
- Telefonní číslo: +390354535327
- E-mail: miriam.rigoldi@marionegri.it
Studijní místa
-
-
BG
-
Bergamo, BG, Itálie, 24126
- Laboratory for Targeted Therapy in Autoimmune Diseases
-
Kontakt:
- Luca Perico, PhD
- Telefonní číslo: +3003542131
- E-mail: luca.perico@marionegri.it
-
Ranica, BG, Itálie, 24020
- Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"
-
Kontakt:
- Miriam Rigoldi, MD
- Telefonní číslo: +390354535327
- E-mail: miriam.rigoldi@marionegri.it
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Young adults
Female and male volunteers aged 18-40 years
|
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.
|
|
Experimentální: Middle-aged adults
Female and male volunteers aged 40-60 years
|
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.
|
|
Experimentální: Elderly adults
Female and male volunteers aged 60-90 years
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Age-dependent differences in cytosolic release of mitochondrial RNA (mtRNA) in primary human fibroblasts
Časové okno: Day 1 (at enrollment)
|
Assessment of release of mtRNA in the cytosol of primary fibroblasts isolated from study participants across age groups.
Cytosolic mtRNA levels assessed through analysis of the mean fluorescence intensity (MFI) per cell by immunofluorescence.
|
Day 1 (at enrollment)
|
|
Age-dependent differences in mitochondrial function in primary human fibroblasts
Časové okno: Day 1 (at enrollment)
|
Characterization of mitochondrial function parameters in primary fibroblasts isolated from study participants across age groups.
Mitochondrial function assessed through analysis of mitochondrial Complex I activity in nmol/min/mg protein by functional ELISA.
|
Day 1 (at enrollment)
|
|
Activation of inflammatory pathways in primary human fibroblasts
Časové okno: Day 1 (at enrollment)
|
Assessment of inflammatory pathway activation markers in fibroblasts isolated from participants across age groups.
Inflammatory pathway activation assessed through Interleukin-6 concentration in skin-derived fibroblast culture supernatant in pg/mL
|
Day 1 (at enrollment)
|
|
Activation of senescence pathways in primary human fibroblasts
Časové okno: Day 1 (at enrollment)
|
Assessment of cellular senescence markers and senescence-associated pathway activation in fibroblasts isolated from participants across age groups.
Senescence pathway activation assessed as percentage (%) of Senescence-associated β-galactosidase (SA-β-gal)-positive cells per microscopic field.
|
Day 1 (at enrollment)
|
|
Comparison of fibroblast findings with PBMC-derived parameters from the same participants
Časové okno: Day 1 (at enrollment)
|
Integration and comparison of fibroblast-derived molecular data with corresponding PBMC-derived measurements obtained from the same participants as described above.
|
Day 1 (at enrollment)
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Giuseppe Remuzzi, Istituto Di Ricerche Farmacologiche Mario Negri
Publikace a užitečné odkazy
Obecné publikace
- Zuber TJ. Punch biopsy of the skin. Am Fam Physician. 2002 Mar 15;65(6):1155-8, 1161-2, 1164.
- Nischal U, Nischal Kc, Khopkar U. Techniques of skin biopsy and practical considerations. J Cutan Aesthet Surg. 2008 Jul;1(2):107-11. doi: 10.4103/0974-2077.44174.
- Yasui Y, Kato H, Oda T, Nakamura M, Morita A. Complications and risk factors of punch biopsy: A retrospective large-scale study. J Dermatol. 2023 Jan;50(1):98-101. doi: 10.1111/1346-8138.16585. Epub 2022 Sep 24.
- Akiyama Y, Norimatsu Y, Ohno Y. Prophylactic antimicrobials may not be needed to prevent surgical site infection after skin biopsy: a retrospective study. Antimicrob Resist Infect Control. 2022 Feb 16;11(1):35. doi: 10.1186/s13756-022-01077-z.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Patologické procesy
- Metabolické choroby
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Zánět
- Mitochondriální onemocnění
- Vyšetřovací techniky
- Manipulace se vzorkem
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Vpichy
- Chirurgické postupy, operativní
- Sběr vzorků krve
Další identifikační čísla studie
- MIRACLE
- FIS-2024-00858 (Jiné číslo grantu/financování: Italian Ministry of University and Research)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .