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

NCT07048054 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-00327
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

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)

  Week 12

Secondary Outcomes (12)

• Number of patients with localised infection (TILI score ≥ 5) not suspicious for irritative or allergic contact dermatitis

  Week 12

• Extent of pruritus, as determined by Numerical Rating Score (NRS).

  Week 12

• Number of patients with hyper-cicatrisation

  Week 12

• Number of patients with pathologic scar

  Week 12

• Number of patients developing donor-HLA antibodies

  Week 12

Other Outcomes (7)

• Translational research - State of systemic and local (wound) inflammatory status

  Enrolment, week 2 and 12

• Translational research - Persistence of TrophiPatch fibres and ASC cells

  Enrolment, week 2 and 12

• Translational research - Development of anti-donor (HLA) specific antibodies

  Enrolment, week 2 and 12

Study Arms (1)

TrophiPatch treatment

EXPERIMENTAL

one time application of TrophiPatch

Drug: TrophiPatch: allogeneic adipose-derived stromal cell patch

Interventions

TrophiPatch: allogeneic adipose-derived stromal cell patch DRUG

Topical application of an allogeneic adipose-derived stromal cell patch

TrophiPatch treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• (for VLU only)
• Diagnosed with at least one venous leg ulcer.
• Ulcers duration for 6 weeks to 3 years at the time of screening.
• Hard-to-healed ulcers with cross-sectional area that have decreased by less than 40% during a four-week run-in period.
• Reference ulcer surface from 5 to 25 cm2.
• Absence of significant arterial insufficiency assessed at clinical examination (intermittent claudication or resting pain, necrotic or distal wound on the foot) and systolic homolateral ankle-brachial index (ABI) greater than 0.75 and inferior to 1.40 or biphasic or triphasic Doppler signals in the dorsalis or posterior tibial arteries of the affected limb.
• (for DFU only)
• Patient with type 1 or type 2 diabetes.
• Diagnosed with at least one diabetic foot ulcer on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft.
• Ulcers duration for 4 weeks to 3 years at the time of screening.
• Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four-week run-in period.
• Reference ulcer surface from 1 to 25 cm2.

You may not qualify if:

• Subject has a history of:
• endstage renal disease
• uncontrolled cardiac failure
• severe malnutrition
• severe liver disease
• aplastic anemia
• malignant disease (active or recent (\<5 years))diabetes avec HbA1C \> 12%
• rheumatoid arthritis
• sickle cell disease
• other connective tissue disorder
• irradiation to the affected extremity
• Serum creatinine concentration greater than 180 umol/L and/or receipt of renal dialysis or an estimated glomerular filtration rate (based on cystatin C or serum creatinine) of less than 20 mL/min per 1·73 m²
• Drug or alcohol abuse.
• Limited physical capacity or total immobility.
• Known pregnancy or nursing at the time of screening visit

Sponsors & Collaborators

• Nicolò Brembilla: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Central Study Contacts

Nicolo C Brembilla, Dr

CONTACT

0041(0)22 3795751; nicolo.brembilla@hug.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical study coordinator

Model Details: One-arm monocentric phase I/lla trial of allogenic adipose-derived stromal cells for the treatment of chronic leg ulcers resistant to standard therapy.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 2, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CH (1)