Safety of Topical Exosome-Containing Liquid in Healthy Volunteers (EV-SAFE-1)
12 de julio de 2026 actualizado por: 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
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 burn wound or artificial skin wound will be induced in participants in this Phase 1 safety study.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigational product is a sterile topical exosome-containing liquid being developed for future evaluation in burn wound repair. Preclinical in vivo evaluation in murine wound models suggested improved wound closure and better histological organization of repaired skin after topical exosome-containing formulation administration, with the therapeutic effect being more pronounced in the thermal burn model. In the burn model, the exosome-containing formulation group showed faster wound-area reduction, improved epidermal and dermal organization, reduced inflammatory cellularity, 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 burn wounds. No artificial burn wound or 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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
10
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nadiar M Mussin, PhD
- Número de teléfono: +7 777 297 8901
- Correo electrónico: nadiar_musin@zkmu.kz
Copia de seguridad de contactos de estudio
- Nombre: Amin Tamadon, PhD
- Número de teléfono: +7 705 629 9350
- Correo electrónico: tamadon@zkmu.kz
Ubicaciones de estudio
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Aktobe
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Aktobe, Aktobe, Kazajstán, 030012
- ATMP center of West Kazakhstan Marat Ospanov Medical University
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Contacto:
- Nadiar M Mussin, PhD
- Número de teléfono: +7 777 297 8901
- Correo electrónico: nadiar_musin@zkmu.kz
-
Contacto:
- Amin Tamadon, PhD
- Número de teléfono: 87056299350
- Correo electrónico: amintamaddon@yahoo.com
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Investigador principal:
- Amin Tamadon, PhD
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Investigador principal:
- Nadiar M Mussin, PhD
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Investigador principal:
- Mahdi Mahdipour, PhD
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Sub-Investigador:
- Kulyash R. Zhilisbayeva, MSc
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Sub-Investigador:
- Ogay V. Borisovich, PhD
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Sub-Investigador:
- Nader Tanideh, PhD
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Healthy adult volunteers aged 18 to 55 years.
- Able and willing to provide written informed consent.
- No clinically significant abnormality based on medical history, physical examination, vital signs, and screening laboratory tests.
- Intact healthy skin at the planned application sites.
- Willingness to avoid applying other topical products, cosmetics, antiseptics, or irritant substances to the application sites during the study period.
- Willingness to avoid excessive sun exposure, sauna, swimming pool use, and mechanical irritation of the application sites during the study period.
- Willingness to comply with all study visits, topical application procedures, local skin assessments, skin photography, safety assessments, and follow-up.
- 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:
- 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.
- 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.
- Current acute illness, fever, or active infection.
- Known autoimmune disease, immunodeficiency, or current systemic immunosuppressive therapy.
- Use of systemic corticosteroids, immunomodulatory drugs, biological agents, or investigational products within 30 days before enrollment.
- 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.
- Clinically significant hepatic, renal, cardiovascular, hematologic, endocrine, neurologic, psychiatric, or systemic disease that may increase risk or interfere with interpretation of study results.
- Known active malignancy or history of malignancy within the past 5 years.
- Positive screening test for clinically relevant transmissible infection, if required by the protocol.
- Pregnancy or breastfeeding.
- Positive pregnancy test at screening or before first application in women of childbearing potential.
- Participation in another interventional clinical trial within 30 days before enrollment.
- Blood donation or major blood loss within 30 days before enrollment, if laboratory safety monitoring is included in the protocol.
- Any condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study results.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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 burn wound or artificial skin wound will be induced.
|
The investigational product is a sterile topical liquid containing exosome-enriched extracellular vesicles derived from [insert cell source, e.g., mesenchymal stromal cells].
The liquid will be applied topically to a small defined area of intact skin at a dose of [insert exact dose, e.g., X mL/cm² containing Y particles/mL, equivalent to Z particles/cm²] according to the protocol-defined schedule.
The product is investigational and is being evaluated for safety and dermal tolerability before future testing in patients with burn wounds.
Otros nombres:
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events
Periodo de tiempo: From first application through Day 28
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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.
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From first application through Day 28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maximum Total Score on the Draize Dermal Irritation Scale at the Exosome-Containing Liquid Application Site
Periodo de tiempo: 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.
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Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
|
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Within-Participant Difference in Total Draize Dermal Irritation Scale Score Between Exosome-Containing Liquid and Vehicle-Control Sites
Periodo de tiempo: Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
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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.
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Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
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Number of Participants With Clinically Significant Vital Sign Abnormalities
Periodo de tiempo: From first application through Day 28
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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.
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From first application through Day 28
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Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Periodo de tiempo: From first application through Day 28
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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.
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From first application through Day 28
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Percentage of Planned Topical Applications Completed According to Protocol
Periodo de tiempo: From Day 0 through Day 14
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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.
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From Day 0 through Day 14
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Number of Participants With Delayed Treatment-Emergent Adverse Events
Periodo de tiempo: From Day 29 through Day 56
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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.
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From Day 29 through Day 56
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Wang M, Xu X, Lei X, Tan J, Xie H. Mesenchymal stem cell-based therapy for burn wound healing. Burns Trauma. 2021 May 1;9:tkab002. doi: 10.1093/burnst/tkab002. eCollection 2021.
- Manzoor T, Farooq N, Sharma A, Shiekh PA, Hassan A, Dar LA, Nazir J, Godha M, Sheikh FA, Gugjoo MB, Saleem S, Ahmad SM. Exosomes in nanomedicine: a promising cell-free therapeutic intervention in burn wounds. Stem Cell Res Ther. 2024 Oct 9;15(1):355. doi: 10.1186/s13287-024-03970-3.
- Hu JC, Zheng CX, Sui BD, Liu WJ, Jin Y. Mesenchymal stem cell-derived exosomes: A novel and potential remedy for cutaneous wound healing and regeneration. World J Stem Cells. 2022 May 26;14(5):318-329. doi: 10.4252/wjsc.v14.i5.318.
- Welsh JA, Goberdhan DCI, O'Driscoll L, Buzas EI, Blenkiron C, Bussolati B, Cai H, Di Vizio D, Driedonks TAP, Erdbrugger U, Falcon-Perez JM, Fu QL, Hill AF, Lenassi M, Lim SK, Mahoney MG, Mohanty S, Moller A, Nieuwland R, Ochiya T, Sahoo S, Torrecilhas AC, Zheng L, Zijlstra A, Abuelreich S, Bagabas R, Bergese P, Bridges EM, Brucale M, Burger D, Carney RP, Cocucci E, Crescitelli R, Hanser E, Harris AL, Haughey NJ, Hendrix A, Ivanov AR, Jovanovic-Talisman T, Kruh-Garcia NA, Ku'ulei-Lyn Faustino V, Kyburz D, Lasser C, Lennon KM, Lotvall J, Maddox AL, Martens-Uzunova ES, Mizenko RR, Newman LA, Ridolfi A, Rohde E, Rojalin T, Rowland A, Saftics A, Sandau US, Saugstad JA, Shekari F, Swift S, Ter-Ovanesyan D, Tosar JP, Useckaite Z, Valle F, Varga Z, van der Pol E, van Herwijnen MJC, Wauben MHM, Wehman AM, Williams S, Zendrini A, Zimmerman AJ; MISEV Consortium; Thery C, Witwer KW. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. J Extracell Vesicles. 2024 Feb;13(2):e12404. doi: 10.1002/jev2.12404.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de enero de 2027
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de julio de 2026
Publicado por primera vez (Actual)
15 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WKMU-EV-SAFE-001
- IRN BR25593457 (Otro número de subvención/financiamiento: Ministry of Healthcare of the Republic of Kazakhstan)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .