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Safety of Topical Exosome-Containing Liquid in Healthy Volunteers for Future Surgical Wound Use (EV-MELSAFE)

12. července 2026 aktualizováno: Amin Tamadon, West Kazakhstan Marat Ospanov Medical University

A Phase 1 Split-Site Pilot Study to Evaluate the Safety and Dermal Tolerability of Topical Exosome-Containing Liquid in Healthy Adult Volunteers Before Future Testing in Post-Melanoma-Excision Surgical Wounds

This Phase 1 split-site pilot study will evaluate the safety and dermal tolerability of a topical exosome-containing liquid in 10 healthy adult volunteers. The investigational liquid will be applied to a small defined area of intact skin. A vehicle liquid without exosomes may be applied to a matched contralateral skin site as a control. The study will assess local skin reactions, systemic adverse events, vital signs, clinical laboratory parameters, and feasibility of topical administration. No melanoma lesion, surgical wound, burn wound, or artificial skin wound will be induced in participants in this Phase 1 safety study.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

The investigational product is a sterile topical exosome-containing liquid being developed for future evaluation in postoperative skin wound repair after melanoma excision. Preclinical in vivo evaluation in a murine surgical post-melanoma-excision wound model suggested improved wound closure kinetics and better histological organization of repaired skin after topical exosome-containing formulation administration. In the surgical wound model, the exosome-containing formulation group showed a faster wound-area reduction trend, significant wound-area reduction at selected time points, improved epithelialization, more organized regenerated tissue, fewer tissue defect-associated spaces, and no significant body-weight differences compared with control groups.

This first-in-human Phase 1 study is designed to evaluate safety and dermal tolerability in healthy adult volunteers before the product is tested in patients with postoperative wounds after melanoma excision. No melanoma lesion, surgical wound, burn wound, or artificial skin wound will be created. The investigational liquid will be applied to a small defined area of intact skin according to the protocol-defined dose and schedule. If a split-site design is used, vehicle liquid without exosomes will be applied to a matched contralateral intact skin site as a control. Participants will be monitored for local skin irritation, erythema, edema, pruritus, burning sensation, pain, rash, allergic reaction, systemic adverse events, vital signs, and clinical laboratory abnormalities.

The first two participants will be enrolled as sentinel participants. Safety data through at least 72 hours after first application will be reviewed before enrollment of the remaining participants. The main purpose of the study is to determine whether topical administration of the exosome-containing liquid is safe and tolerable on intact human skin before future clinical evaluation in post-melanoma-excision surgical wound repair.

Typ studie

Intervenční

Zápis (Odhadovaný)

10

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Kazachstán
    • Aktobe
      • Aktobe, Aktobe, Kazachstán, 030012
        • ATMP center of West Kazakhstan Marat Ospanov Medical University
        • Kontakt:
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  1. Healthy adult volunteers aged 18 to 55 years.
  2. Able and willing to provide written informed consent.
  3. No clinically significant abnormality based on medical history, physical examination, vital signs, and screening laboratory tests.
  4. Intact healthy skin at the planned application sites.
  5. Willingness to avoid applying other topical products, cosmetics, antiseptics, or irritant substances to the application sites during the study period.
  6. Willingness to avoid excessive sun exposure, sauna, swimming pool use, and mechanical irritation of the application sites during the study period.
  7. Willingness to comply with all study visits, topical application procedures, local skin assessments, skin photography, safety assessments, and follow-up.
  8. For women of childbearing potential, a negative pregnancy test before first application and willingness to use an acceptable method of contraception during the study period.

Exclusion Criteria:

  1. Any active skin disease, dermatitis, eczema, psoriasis, urticaria, acneiform eruption, skin infection, open wound, scar, tattoo, burn scar, pigmentation disorder, or clinically significant skin abnormality at the planned application sites.
  2. History of severe allergy, anaphylaxis, or hypersensitivity to topical liquids, dressings, biological products, exosome-containing products, or any component of the investigational product or vehicle liquid.
  3. Current acute illness, fever, or active infection.
  4. Known autoimmune disease, immunodeficiency, or current systemic immunosuppressive therapy.
  5. Use of systemic corticosteroids, immunomodulatory drugs, biological agents, or investigational products within 30 days before enrollment.
  6. Use of topical corticosteroids, topical immunomodulators, topical antibiotics, retinoids, keratolytic agents, or other medicated topical products on or near the planned application sites within 14 days before enrollment.
  7. Clinically significant hepatic, renal, cardiovascular, hematologic, endocrine, neurologic, psychiatric, or systemic disease that may increase risk or interfere with interpretation of study results.
  8. Known active malignancy or history of malignancy within the past 5 years.
  9. Positive screening test for clinically relevant transmissible infection, if required by the protocol.
  10. Pregnancy or breastfeeding.
  11. Positive pregnancy test at screening or before first application in women of childbearing potential.
  12. Participation in another interventional clinical trial within 30 days before enrollment.
  13. Blood donation or major blood loss within 30 days before enrollment, if laboratory safety monitoring is included in the protocol.
  14. Any condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study results.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Exosome-Containing Liquid and Vehicle-Control Skin Sites
Healthy adult volunteers will receive topical exosome-containing liquid applied to a small defined area of intact skin. In the split-site design, vehicle liquid without exosomes will be applied to a matched contralateral intact skin site as a control. No melanoma lesion, surgical wound, burn wound, or artificial skin wound will be induced.
Jiný: Vehicle Liquid
Vehicle liquid without exosomes will be applied topically to a matched contralateral intact skin site according to the same protocol-defined schedule as the exosome-containing liquid. The vehicle liquid is used as a within-participant control for local dermal tolerability assessment.
Biologický: Exosome-Containing Liquid
The investigational product is a sterile topical liquid containing exosome-enriched extracellular vesicles derived from human umbilical cord-derived mesenchymal stromal cells. The liquid will be applied topically to a small defined area of intact skin at a dose of 0.1 mL/cm², containing 1 × 10^10 extracellular vesicle particles/mL, equivalent to 1 × 10^9 extracellular vesicle particles/cm², according to the approved protocol-defined schedule. The product is investigational and is being evaluated for safety and dermal tolerability before future testing in patients with postoperative wounds after melanoma excision.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Treatment-Emergent Adverse Events
Časové okno: From first application through Day 28
Number of participants with any treatment-emergent adverse event after topical application of the exosome-containing liquid. Events include local application-site reactions such as erythema, edema, pruritus, burning sensation, pain, rash, vesicles, ulceration, allergic reaction, or infection, and systemic events such as fever, malaise, abnormal vital signs, clinically significant laboratory abnormalities, serious adverse events, or any other clinically significant adverse event judged by the investigator.
From first application through Day 28

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Maximum Total Score on the Draize Dermal Irritation Scale at the Exosome-Containing Liquid Application Site
Časové okno: Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
The Draize Dermal Irritation Scale grades erythema and eschar formation from 0, indicating no erythema, to 4, indicating severe erythema or eschar formation, and edema from 0, indicating no edema, to 4, indicating severe edema. The total score is the sum of the erythema/eschar score and edema score and ranges from 0 to 8. Higher scores indicate worse local skin irritation. The maximum total score observed at the exosome-containing liquid application site will be reported.
Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
Within-Participant Difference in Total Draize Dermal Irritation Scale Score Between Exosome-Containing Liquid and Vehicle-Control Sites
Časové okno: Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
The within-participant difference will be calculated as the total Draize Dermal Irritation Scale score at the exosome-containing liquid application site minus the total score at the vehicle-control liquid application site at each assessment time point. The total Draize score ranges from 0 to 8, with higher scores indicating worse local skin irritation. Positive values indicate higher irritation at the exosome-containing liquid site, and negative values indicate higher irritation at the vehicle-control site.
Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
Number of Participants With Clinically Significant Vital Sign Abnormalities
Časové okno: From first application through Day 28
Number of participants with any clinically significant abnormality in vital signs after topical application of the exosome-containing liquid. Vital signs include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance will be determined by the investigator using protocol-defined reference ranges and clinical judgment. The reporting unit is number of participants.
From first application through Day 28
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Časové okno: From first application through Day 28
Number of participants with any clinically significant abnormality in clinical laboratory safety tests after topical application of the exosome-containing liquid. Laboratory safety tests include complete blood count, renal function tests, liver function tests, and inflammatory markers according to the protocol. Clinical significance will be determined by the investigator using protocol-defined reference ranges and clinical judgment. The reporting unit is number of participants.
From first application through Day 28
Number of Participants With Delayed Treatment-Emergent Adverse Events
Časové okno: From Day 29 through Day 56
Number of participants with delayed local or systemic treatment-emergent adverse events occurring after completion of the primary Day 28 safety assessment. Delayed events may include local skin reactions, allergic reactions, infection, abnormal vital signs, clinically significant laboratory abnormalities, serious adverse events, or any other clinically significant adverse event judged by the investigator.
From Day 29 through Day 56
Percentage of Planned Topical Applications Completed According to Protocol
Časové okno: From Day 0 through Day 7 or Day 14, according to the protocol-defined application schedule
For each participant, the topical application completion percentage will be calculated as the number of completed topical applications divided by the number of protocol-planned topical applications, multiplied by 100. The outcome will be reported as the mean percentage of planned topical applications completed across participants. A higher percentage indicates better feasibility of topical application.
From Day 0 through Day 7 or Day 14, according to the protocol-defined application schedule

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

West Kazakhstan Marat Ospanov Medical University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. prosince 2026

Dokončení studie (Odhadovaný)

1. ledna 2027

Termíny zápisu do studia

První předloženo

7. července 2026

První předloženo, které splnilo kritéria kontroly kvality

12. července 2026

První zveřejněno (Aktuální)

16. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • WKMU-EV-MELSAFE-001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

No. Individual participant data will not be shared because this is a small Phase 1 first-in-human safety and dermal tolerability study in 10 healthy volunteers, and de-identified individual-level data may still carry a risk of participant re-identification. Aggregate study results, adverse event summaries, and protocol-defined outcome summaries may be reported in ClinicalTrials.gov and in peer-reviewed publications.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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