Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-20 @ 3:51 PM
Study NCT ID:
NCT06429033
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2024-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Purified Exosome Product (PEP) Injected Into the Hypodermis
Sponsor:
Clinical Testing of Beverly Hills
Organization:
Study Overview
Official Title:
A Phase 1 Controlled Study to Evaluate the Safety and Tolerability of Intradermal Administered Purified Exosome Product (PEP) in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEP
Brief Summary:
This clinical trial aims to characterize the safety, tolerability, and histological profile of PEP (Purified Exosome Product) when injected into the hypodermis of healthy adults. The main questions this study aims to answer are:
Is PEP safe and tolerable when injected into the hypodermis of healthy adults?
Subjects will serve as their own control and researchers will compare PEP to Control to see if PEP is safe.
Is PEP safe and tolerable when injected into the hypodermis of healthy adults?
Subjects will serve as their own control and researchers will compare PEP to Control to see if PEP is safe.
Detailed Description:
This is a prospective, non-randomized, within-subject, controlled, single center, open-label study. Up to 9 healthy adult participants with planned elective body reduction surgery to remove excess skin on the abdomen in 30-45 days will be enrolled and injected with a single dose of PEP Drug Product reconstituted in Lactated Ringers (USP) solution in a defined area of the abdominal hypodermis. Similar tissue from the participant's contralateral side of the abdomen will serve as the control. Excised tissue will be harvested and analyzed for key biological markers for skin quality and senescence such as collagen and elastin. The primary goal of this investigator-initiated study is to determine safety of subcutaneous PEP Drug Product when reconstituted in Lactated Ringers solution. Safety data will be collected with frequent monitoring for adverse events, laboratory testing, vital signs, and ECGs.
Note: The decision to undergo abdominoplasty will be made outside of this study and data/safety in the plastic surgery procedure for abdominoplasty, other than informed consent, will not be a collected as a part of this study.
Note: The decision to undergo abdominoplasty will be made outside of this study and data/safety in the plastic surgery procedure for abdominoplasty, other than informed consent, will not be a collected as a part of this study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: