Purified Exosome Product for Safety
(PEP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new treatment called Purified Exosome Product (PEP). Researchers aim to determine its safety and behavior when injected into the skin of healthy adults. Participants must be planning elective surgery to remove excess abdominal skin. This trial ensures PEP's safety before considering wider use. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on hormone replacement therapy or birth control, your dose must be stable for at least 6 months before joining. Also, you should not be using corticosteroids regularly in the 4 weeks before the study, except for inhaled or topical ones outside the treatment area.
What prior data suggests that Purified Exosome Product (PEP) is safe for injection into the hypodermis?
Research shows that the Purified Exosome Product (PEP) is generally safe and well-tolerated in people. Studies have found that PEP has been safely used in healing tendons, cartilage, bones, wounds, and nerve tissues, indicating no major problems for these purposes.
PEP is produced under strict quality standards, ensuring purity and safety. For instance, PEP successfully aided in healing a difficult scalp wound without causing harm.
Overall, these findings suggest that PEP usually doesn't cause serious side effects. However, since this study is in an early phase, it primarily focuses on understanding the safety of PEP when injected into the skin of healthy adults.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for skin rejuvenation and repair, which often involve topical creams, injections of fillers, or laser therapies, the Purified Exosome Product (PEP) is unique because it leverages exosomes, which are small particles that facilitate cell communication and tissue repair. This treatment is administered intradermally, directly into the skin layers, allowing for targeted delivery and potentially enhancing its effectiveness. Researchers are excited about PEP because it represents a novel mechanism of action—using the body’s natural cellular messengers to promote healing and rejuvenation, which could lead to more efficient and natural results compared to traditional methods.
What evidence suggests that Purified Exosome Product (PEP) is safe and tolerable for healthy adults?
Research has shown that Purified Exosome Product (PEP) may aid in healing. In one study, PEP helped rotator cuff tendons heal faster after surgery. Another report demonstrated its effectiveness in treating a difficult scalp wound that was not healing well. Early research also suggests PEP might help prevent complications after certain surgeries. While these results are promising, they pertain to different conditions than the current trial, so further research is needed to fully understand PEP's potential. Participants in this trial will receive a single dose of PEP to evaluate its safety in a specific surgical context.56789
Who Is on the Research Team?
John H Joseph, MD
Principal Investigator
Clinical Testing Center
Are You a Good Fit for This Trial?
Healthy adults aged 18-65 planning elective abdominal skin reduction surgery in the next 3-5 months can join. They must be using birth control, not pregnant, and have no significant medical findings. Participants should agree to follow study rules and avoid other aesthetic treatments during the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of PEP (Purified Exosome Product) injected into the hypodermis
Follow-up
Participants are monitored for safety and effectiveness after treatment, including monitoring for adverse events and laboratory testing
Histopathology Evaluation
Histology evaluation of excised tissue for key biological markers
What Are the Treatments Tested in This Trial?
Interventions
- Purified Exosome Product (PEP)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Clinical Testing of Beverly Hills
Lead Sponsor