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Exosome injection safety checked in small study

NCT ID NCT06429033

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested whether a purified exosome product (PEP) is safe when injected into the skin of healthy adults. Eight participants received the injection and were monitored for side effects. The goal was to check for any immediate reactions or lab changes, not to treat a disease.

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

8 people

The number who actually took part.

Started

Apr 2025

Finished

Dec 2025

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 65 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: * Adult participants aged 18-65 (inclusive) * Capacity to sign informed consent. * Planned elective body reduction surgery to remove excess skin on the abdomen in ≥ 12 to ≤ 18 weeks * Participant is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, vital signs, and clinical laboratory tests. * Participant should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods (laser devices, topical prescriptions, or other known hair growth treatments) in the treatment area during the entire study period. * Females of childbearing potential must be using an approved method of birth control for the past month and during the entire study period. Participants who can become pregnant will undergo a pregnancy test prior to treatment. Exclusion Criteria: * Participants with clinically abnormal hematology, serum chemistries, or screening laboratory results as reviewed by the clinical investigator. * Known history of MRSA (methicillin-resistant staphylococcus aureus). * Known history of COVID-19 infection in past 6 months. * COVID vaccine or booster dose within past 12 weeks. * Participants who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody, or HIV. * History of antibiotic use in past 12 weeks. * Major surgery in past 3 months. * If taking hormone replacement therapy or hormones for birth control, dose must be stable for at least 6 months prior to study entry. * Current or regular use of corticosteroids during the previous 4 weeks, excluding inhaled or topical steroids outside of the planned treatment area. * Known sensitivity/allergy to study product ingredients. * Pregnancy and nursing or lactating. * Sexually active women of childbearing potential who are unwilling to use approved contraception method for three months after receiving dose of investigational drug. * Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications. * Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, history of any malignancies or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study. * Participants with hepatic impairment * Participants with poorly controlled diabetes mellitus (HbA1C ≥ 8%). * Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. * History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. * Any surgery or treatment such as laser or chemicals in the treatment area within 6 months prior to treatment * History of excessive UV exposure (e.g., frequent sunburn, use of tanning beds, or prolonged outdoor activities without adequate sun protection) * Any medical condition that in the opinion of the investigator, such condition would compromise the safety of the participant or quality of the study data. * Current, or past participation in a clinical trial within the past 30 days.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clinical Testing of Beverly Hills

    Encino, California, 91436, United States

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