Basement Membrane Regeneration Wound Repair Observational Study
Summary
This document registers a prospective, multicenter, observational study (NCT07551284) evaluating autologous basement membrane regeneration technology for wound repair in 1,000 patients across multiple hospitals in China. The study will compare 500 patients receiving the cell suspension therapy combined with standard surgical procedures against 500 matched patients receiving standard procedures alone, with primary outcomes including complete wound healing rate at 4 weeks and time to complete wound closure, followed for up to 6 months.
“A total of 500 patients receiving the cell suspension therapy combined with standard surgical procedures will be enrolled from multiple hospitals across China.”
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What changed
A new clinical trial registration for basement membrane regeneration in wound repair has been added to ClinicalTrials.gov. The study is a prospective, multicenter, real-world observational study that will enroll 1,000 patients across multiple hospitals in China, with 500 receiving the cell suspension therapy and 500 in the control group receiving standard surgical procedures alone.
Healthcare providers, clinical researchers, and wound care specialists should monitor this trial's outcomes, as positive results could influence treatment protocols for wound healing. The study's 6-month follow-up period and specific outcome measures including wound healing rate at 4 weeks and time to complete wound closure will provide data on the effectiveness and safety of this autologous cell-based approach.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Basement Membrane Regeneration for Wound Repair
Observational NCT07551284 Kind: OBSERVATIONAL Apr 24, 2026
Abstract
This study is a prospective, multicenter, real-world observational study. It aims to evaluate the effectiveness and safety of autologous basement membrane regeneration technology (epidermal basal cell suspension prepared using a cell sorting system) for wound repair in patients undergoing skin grafting, flap surgery, or primary suture. A total of 500 patients receiving the cell suspension therapy combined with standard surgical procedures will be enrolled from multiple hospitals across China. Their outcomes will be compared with 500 matched patients receiving standard surgical procedures alone (e.g., skin grafting, flap surgery, or suture without cell suspension). The primary outcomes include complete wound healing rate at 4 weeks (for grafted wounds) and time to complete wound closure (for sutured or flap-repaired wounds). Secondary outcomes include wound area reduction rate, recurrence rate, scar assessment (Vancouver Scar Scale), pain score (ASA), sweat function test, basement membrane integrity (histopathology with collagen IV and VII staining if clinically indicated), and safety. Patients will be followed for up to 6 months.
Conditions: Wound Healing
Interventions: Autologous Epidermal Basal Cell Suspension
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