Safety of Topical Exosome-Containing Liquid in Healthy Volunteers (EV-SAFE-1)
2026年7月12日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
10
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nadiar M Mussin, PhD
- 電話番号：+7 777 297 8901
- メール：nadiar_musin@zkmu.kz
研究連絡先のバックアップ
- 名前：Amin Tamadon, PhD
- 電話番号：+7 705 629 9350
- メール：tamadon@zkmu.kz
研究場所
-
-
Aktobe
-
Aktobe、Aktobe、カザフスタン、030012
- ATMP center of West Kazakhstan Marat Ospanov Medical University
-
コンタクト：
- Nadiar M Mussin, PhD
- 電話番号：+7 777 297 8901
- メール：nadiar_musin@zkmu.kz
-
コンタクト：
- Amin Tamadon, PhD
- 電話番号：87056299350
- メール：amintamaddon@yahoo.com
-
主任研究者：
- Amin Tamadon, PhD
-
主任研究者：
- Nadiar M Mussin, PhD
-
主任研究者：
- Mahdi Mahdipour, PhD
-
副調査官：
- Kulyash R. Zhilisbayeva, MSc
-
副調査官：
- Ogay V. Borisovich, PhD
-
副調査官：
- Nader Tanideh, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum Total Score on the Draize Dermal Irritation Scale at the Exosome-Containing Liquid Application Site
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2027年1月1日
試験登録日
最初に提出
2026年7月7日
QC基準を満たした最初の提出物
2026年7月12日
最初の投稿 (実際)
2026年7月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月12日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- WKMU-EV-SAFE-001
- IRN BR25593457 (その他の助成金/資金番号：Ministry of Healthcare of the Republic of Kazakhstan)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。