Safety of Topical Exosome-Containing Liquid in Healthy Volunteers (EV-SAFE-1)
12 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
10
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Nadiar M Mussin, PhD
- Telefonnummer: +7 777 297 8901
- E-post: nadiar_musin@zkmu.kz
Studera Kontakt Backup
- Namn: Amin Tamadon, PhD
- Telefonnummer: +7 705 629 9350
- E-post: tamadon@zkmu.kz
Studieorter
-
-
Aktobe
-
Aktobe, Aktobe, Kazakstan, 030012
- ATMP center of West Kazakhstan Marat Ospanov Medical University
-
Kontakt:
- Nadiar M Mussin, PhD
- Telefonnummer: +7 777 297 8901
- E-post: nadiar_musin@zkmu.kz
-
Kontakt:
- Amin Tamadon, PhD
- Telefonnummer: 87056299350
- E-post: amintamaddon@yahoo.com
-
Huvudutredare:
- Amin Tamadon, PhD
-
Huvudutredare:
- Nadiar M Mussin, PhD
-
Huvudutredare:
- Mahdi Mahdipour, PhD
-
Underutredare:
- Kulyash R. Zhilisbayeva, MSc
-
Underutredare:
- Ogay V. Borisovich, PhD
-
Underutredare:
- Nader Tanideh, PhD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximum Total Score on the Draize Dermal Irritation Scale at the Exosome-Containing Liquid Application Site
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Percentage of Planned Topical Applications Completed According to Protocol
Tidsram: From Day 0 through Day 14
|
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 14
|
|
Number of Participants With Delayed Treatment-Emergent Adverse Events
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 januari 2027
Studieregistreringsdatum
Först inskickad
7 juli 2026
Först inskickad som uppfyllde QC-kriterierna
12 juli 2026
Första postat (Faktisk)
15 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- WKMU-EV-SAFE-001
- IRN BR25593457 (Annat bidrag/finansieringsnummer: Ministry of Healthcare of the Republic of Kazakhstan)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .