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

Official title

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

Overview

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.

Interventions

• Drug TrophiPatch: allogeneic adipose-derived stromal cell patch
  Topical application of an allogeneic adipose-derived stromal cell patch

Primary outcome measures

• Composite safety outcome at week 12 from baseline [Time frame: Week 12]

Secondary outcome measures (12)

• Number of patients with localised infection (TILI score ≥ 5) not suspicious for irritative or allergic contact dermatitis [Time frame: Week 12]
• Extent of pruritus, as determined by Numerical Rating Score (NRS). [Time frame: Week 12]
• Number of patients with hyper-cicatrisation [Time frame: Week 12]
• Number of patients with pathologic scar [Time frame: Week 12]
• Number of patients developing donor-HLA antibodies [Time frame: Week 12]
• Weekly change in ulcer area till week 12 [Time frame: from enrolment to week 12]
• Number of completely healed and epithelised ulcers at week 12. [Time frame: Week 12]
• Weekly evolution of the wound bed score till week 12 [Time frame: From enrolment to week 12]
• Evolution of the quality of blood perfusion of the wound [Time frame: Week 2 and week 12]
• Reduction in pain during the study period [Time frame: From enrolment to week 12]
• Change in quality of life [Time frame: Day 0 and week 12]
• Assessment of patient-relevant benefits during wound therapy [Time frame: Day 0 and week 12]

Eligibility criteria

Inclusion criteria

• 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.
• At the time of inclusion, the ulcer will be clinically non-infected (TILI score ≥ 5).
• 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.
• At the inclusion, the ulcer will be clinically non-infected (according to IDSA criteria).
• HbA1C < 12% at screening.
• Absence of significant arterial insufficiency assessed by 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.

Exclusion criteria

• 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
• Subject is currently receiving (i.e within 30 days prior to inclusion) or scheduled to receive a medication or treatment that, in the opinion of the investigator, will interfere with or affect the rate of wound healing.
• Index ulcers probing to tendon, muscle, capsule and bone.
• Local or systemic signs of ongoing infection.
• Hypersensitivity to silicone or porcine gelatin.
• Previous treatment with growth factors, stem cells, or an equivalent preparation within the 8 weeks before the baseline visit.
• Involvement in another interventional clinical trial within the 4 weeks before the baseline visit.
• Known or suspected absence of capacity to understand the study procedures or provide written informed consent (decided by the investigator).
• Cross-sectional area of the index ulcer had increased by at least 20%.

(for VLU only)

• History of poor compliance with compression therapy.
• Presence of peripheral neuropathy of the lower limbs.

(for DFU only)

• History of poor compliance with offloading therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• University Hospitals of Geneva — Geneva

Identifiers

NCT: NCT07048054 · 2024-00327

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗