Could exosomes from umbilical cord cells help heal skin? first safety trial launches

NCT ID NCT07707986

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This Phase 1 study tests whether a liquid containing exosomes from human umbilical cord cells is safe when applied to healthy skin. Ten healthy adults receive the exosome liquid on one small skin area and a placebo liquid on another. Researchers monitor for redness, swelling, itching, or other reactions. This is a first step before testing the liquid on surgical wounds after melanoma removal.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a topical liquid containing exosomes from human umbilical cord cells
What this could lead to
If safe, this exosome liquid could be tested to help heal surgical wounds after melanoma removal, potentially improving scar appearance or recovery.
What could go wrong
This is a very early Phase 1 safety study with only 10 healthy people. It does not test effectiveness, and skin irritation or allergic reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

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How to take part

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  1. The places running it

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Contacts and locations

Locations

  • ATMP center of West Kazakhstan Marat Ospanov Medical University

    Aktobe, Aktobe, 030012, Kazakhstan

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