Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-05-05 @ 1:59 PM
Study NCT ID:
NCT07474467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars
Sponsor:
CellinCells
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Split-Face, Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Administration of TRTP-101 in Adults With Atrophic Scars
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
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:
None
Brief Summary:
The purpose of this clinical trial was to evaluate the safety and efficacy of a single administration of TRTP-101 in adults with atrophic scars.
Detailed Description:
A phase 1 clinical trial designed to evaluate dose-limiting toxicity (DLT) following single-dose administration of TRTP-101 into four or more atrophic scar sites.
Subsequently, a phase 2 clinical trial will be conducted using a placebo-controlled, split-face design to evaluate the safety and efficacy of TRTP-101. Eligible subjects will have atrophic scars approximately 2 cm in diameter located on both sides of the face (e.g., the cheek or temple areas), and TRTP-101 and placebo will be administered to the respective sides of the face.
Subsequently, a phase 2 clinical trial will be conducted using a placebo-controlled, split-face design to evaluate the safety and efficacy of TRTP-101. Eligible subjects will have atrophic scars approximately 2 cm in diameter located on both sides of the face (e.g., the cheek or temple areas), and TRTP-101 and placebo will be administered to the respective sides of the face.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: