Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNicolò Brembilla
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 years or older.
Patients with more than one eligible ulcer will have one - usually the largest or more clinically significant - selected at screening as the index ulcer.
Participants will have the capacity to understand study procedures, and will be able to providewritten informed consent.
Diagnosed with at least one venous leg ulcer.
Disqualifiers
endstage renal disease
uncontrolled cardiac failure
severe malnutrition
severe liver disease
Trial design
Treatments tested in this trial
- TrophiPatch: allogeneic adipose-derived stromal cell patch
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Nicolò Brembilla
Lead sponsor
University Hospital, Geneva
Sponsor institution
Source ClinicalTrials.gov