NCT05844527

Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients

Safety and Efficacy of MRG-001 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: MedRegen LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Surgical excisions are one of the most frequent cutaneous wounds. This study will compare the safety and preliminary efficacy of a novel fixed-dose combination drug MRG-001 in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing elective abdominoplasty.

Detailed description

Subjects will undergo surgical excisions in the abdominoplasty area and will be treated with MRG-001 or placebo for 3 weeks. After 6 weeks, the excision area is harvested for analysis and the study is terminated and the abdominoplasty is performed.

Conditions

• Wound of Skin
• Abdominal Wound

Interventions

Type	Name	Description
DRUG	MRG-001	MRG-001 is a novel fixed-dose drug combination administered subcutaneously to mobilize stem cells and immunomodulatory cells to the wound to accelerate healing.
DRUG	Saline	Sterile saline will serve as placebo treatment.

Timeline

• Start date: 2023-11-20
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-05-06
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study