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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
TrophiPatch: allogeneic adipose-derived stromal cell patch
DrugTopical application of an allogeneic adipose-derived stromal cell patch
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: TrophiPatch treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Composite safety outcome at week 12 from baseline
Composite outcome including any of the following events: deterioration of the ulcer, as measured by an increase of the ulcer size of \> than 20% at week 12 as compared to d0; and/or presence of spreading infection or systemic infections (criteria according to IWII); and/or presence of treatment-related irritative or allergic contact dermatitis (as per clinical diagnosis)
Time frame
Week 12Secondary outcomes
1
Number of patients with localised infection (TILI score ≥ 5) not suspicious for irritative or allergic contact dermatitis
Time frame
Week 122
Extent of pruritus, as determined by Numerical Rating Score (NRS).
Eleven numbers from 0 to 10 are displayed and patients are asked to pick the number corresponding to the intensity of their pruritus
Time frame
Week 123
Number of patients with hyper-cicatrisation
Clinical evaluation
Time frame
Week 124
Number of patients with pathologic scar
clinical evaluation of cheloid or hypertrophic scar
Time frame
Week 12Other outcomes
1
Translational research - State of systemic and local (wound) inflammatory status
Assessment of systemic and local inflammatory status using multiplex cytokine assays (e.g., Luminex) in plasma and wound fluid, as well as immunohistochemical staining for inflammatory markers in tissue sections.
Time frame
Enrolment, week 2 and 122
Translational research - Persistence of TrophiPatch fibres and ASC cells
Persistence of drug matrix fibers and adipose-derived stromal cells (ASCs) will be evaluated using histological staining (e.g., Masson's trichrome for matrix components and immunolabeling for ASC tracking).
Time frame
Enrolment, week 2 and 123
Translational research - Development of anti-donor (HLA) specific antibodies
Detection of anti-donor (HLA-specific) antibodies in serum using solid-phase assays such as Luminex Single Antigen Bead assays to monitor for humoral alloimmune responses.
Time frame
Enrolment, week 2 and 124
Translational research - Local composition of the inflammatory infiltrate
Characterization of the local inflammatory infiltrate within the healing wound by immunohistochemistry or immunofluorescence, targeting markers for resident and infiltrating cells: neutrophils, eosinophils, T cells, mast cells, macrophages, DCs.
Time frame
enrolment, week 2 and 12.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nicolò Brembilla
Lead sponsor
University Hospital, Geneva
Sponsor institution
Source ClinicalTrials.gov