Safety of Topical Exosome-Containing Liquid in Healthy Volunteers (EV-SAFE-1)
2026년 7월 12일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
10
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Nadiar M Mussin, PhD
- 전화번호: +7 777 297 8901
- 이메일: nadiar_musin@zkmu.kz
연구 연락처 백업
- 이름: Amin Tamadon, PhD
- 전화번호: +7 705 629 9350
- 이메일: tamadon@zkmu.kz
연구 장소
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Aktobe
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Aktobe, Aktobe, 카자흐스탄, 030012
- ATMP center of West Kazakhstan Marat Ospanov Medical University
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연락하다:
- Nadiar M Mussin, PhD
- 전화번호: +7 777 297 8901
- 이메일: nadiar_musin@zkmu.kz
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연락하다:
- Amin Tamadon, PhD
- 전화번호: 87056299350
- 이메일: amintamaddon@yahoo.com
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수석 연구원:
- Amin Tamadon, PhD
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수석 연구원:
- Nadiar M Mussin, PhD
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수석 연구원:
- Mahdi Mahdipour, PhD
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부수사관:
- Kulyash R. Zhilisbayeva, MSc
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부수사관:
- Ogay V. Borisovich, PhD
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부수사관:
- Nader Tanideh, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum Total Score on the Draize Dermal Irritation Scale at the Exosome-Containing Liquid Application Site
기간: Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
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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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2027년 1월 1일
연구 등록 날짜
최초 제출
2026년 7월 7일
QC 기준을 충족하는 최초 제출
2026년 7월 12일
처음 게시됨 (실제)
2026년 7월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 12일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- WKMU-EV-SAFE-001
- IRN BR25593457 (기타 보조금/기금 번호: Ministry of Healthcare of the Republic of Kazakhstan)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .