Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-15
Brief Title:
Purified Exosome Product PEP Injected Into the Hypodermis
Sponsor:
Clinical Testing of Beverly Hills
Organization:
Clinical Testing of Beverly Hills
Study Overview
Official Title:
A Prospective Within-Subject Controlled Study to Evaluate the Safety and Tolerability of Purified Exosome Product Into the Hypodermis of Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 12 to 18 weeks 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 participants 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 datasafety 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 datasafety 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:
None
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?:
None