NCT07048054

Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers

Allogenic Adipose-derived Stromal Cell Patch (i.e TrophiPatch, Provided by HekeTiss®) for Chronic Leg Ulcers Resistant to Standard Treatment: Safety and Preliminary Efficacy, a One-arm Monocentric Phase I-ll Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Nicolò Brembilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and effectiveness of an experimental biological dressing called TrophiPatch, applied to adults with chronic leg ulcers of diabetic or vascular orign. TrophiPatch contains stromal cells derived from a donor's fat tissue, which are purified and processed in a certified laboratory. These cells have shown wound-healing, anti-inflammatory and pro-angiogenic properties in preclinical studies. All 18 participants will receive a single application of TrophiPatch on their wound. The total study duration is up to 24 weeks, with 23 scheduled visits for follow-up and monitoring.

Conditions

• Diabetic Foot Ulcer (DFU)
• Venous Leg Ulcer (VLU)

Interventions

Type	Name	Description
DRUG	TrophiPatch: allogeneic adipose-derived stromal cell patch	Topical application of an allogeneic adipose-derived stromal cell patch

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-07-02
• Last updated: 2025-07-02

Locations

1 site across 1 country: Switzerland