Human fibroblasts for Chronic refractory wounds | Skin wound

Inclusion criteria

• {"criterion_text":"- Properly executed written informed consent form (ICF).\n- Males and females aged ≥18 years, inclusive, at the screening visit.\n- BMI between 18.5 kg/m2 and 40 kg/m2, inclusive, and weight of at least 45 kg at screening.\n- Negative pregnancy test.\n- Females participating in the study must be either: - of non-childbearing potential (e.g., surgically sterilized or postmenopausal with no menstrual bleeding for at least 2 years prior the study and corresponding follicle-stimulating hormone and estradiol levels), or - if fertile, abstaining from sexual intercourse while participating in the study, or using highly effective contraceptive methods.\n- Male participants with female partners of child-bearing potential must be willing to use highly effective contraception methods\n- Patients, with one single ulcer to the inferior limbs present for at least 3 months, in whom other attempts at treatment have failed*, with infection grade 0-1 according to current WIfI1 guidelines. The ulcer selected for treatment (index lesion) must have a surface area between 5 and 40 cm2. *Possible previous failed treatments include (the list is not exhaustive): • removal of necrotic tissue through debridement (typically sharp debridement); • maintenance of moisture balance by selecting the proper wound dressing to control exudate; • measures to prevent or treat wound infections; • measures to correct ischemia in the wound area; • for venous leg ulcers, application of some form of compression; • for diabetic foot ulcers, application of some form of offloading; • application of other skin substitutes.\n- Patients candidate to surgical debridment of the ulcer and receiving such procedure, as part of the clinical practice, no more than 24 hours before the planned study product application.\n- Willing and able to comply with all study requirements, schedules and procedures."}

Exclusion criteria

• {"criterion_text":"- Clinical evidence of acute cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal, haematological, bleeding disorders, neurological or psychiatric pathology or other chronic diseases, that in the opinion of the investigator, could jeopardize or would compromise the participant’s ability to participate in this study.\n- Any patient who, in the judgment of the Investigator, is likely to be non-compliant with study procedures and/or restrictions, or unable to cooperate\n- Active alcohol, medicine or substance abuse within the last 2 years.\n- Acute ulcer (<3 months).\n- Impaired nutritional status (BMI <18,5, Serum albumin <2.4 g / dL, weight loss >10% of ideal weight in the last 3 months).\n- Any other concomitant disease or treatment which could significantly affect the healing process during the study (i.e. use of corticosteroids, NSAIDs, immunosuppressive or cytotoxic agents, etc) or any treatment that might interfere with the assessment of the study treatment. Therapies with steroids and immunosuppressants are admitted only if stable for at least 3 months before entering the study and intended not to be modified during the course of the study\n- Breast-feeding and pregnant females as per positive urine β-HCG.\n- Patients who are not, or whose partners are not, willing to use appropriate contraception from the time of the first dose until the end of the study\n- Patients receiving concomitant treatment with other investigational drugs or having participated in another clinical trial within the previous 3 months before their inclusion in the study (i.e., ICF signature date)\n- Patients with known allergy to collagen, streptomycin, penicillin and/or products of bovine origin."}

Primary endpoints

• {"endpoint_text":"- Safety endpoints: Incidence, type, intensity (severity), seriousness and treatment causality of Treatment Emergent Adverse Events (TEAEs, i.e. AEs that occur after the product application).","definition_or_measurement_approach":"Collect and report incidence, type, severity, seriousness and causality of TEAEs occurring after product application."}
• {"endpoint_text":"- Safety endpoints: Changes from baseline in physical examination, vital signs, 12-lead ECG, blood and urine analyses.","definition_or_measurement_approach":"Assessment of changes from baseline in physical exam, vital signs, 12-lead ECG, and laboratory (blood and urine) tests."}
• {"endpoint_text":"- Safety endpoints: Overall tolerability assessment by the Investigator measured through a 5-points Likert Scale (1=very well tolerated, 2=well tolerated, 3=neither well nor badly tolerated, 4=not tolerated, 5=not tolerated at all).","definition_or_measurement_approach":"Investigator-rated tolerability using a 5-point Likert scale as specified."}
• {"endpoint_text":"- Efficacy endpoints: Ulcer dimension change from baseline (scored in six categories: 0=unchanged, 1=reduction ≤30%, 2=reduction between 30 and 50%, 3=reduction between 50 and 70%, 4=reduction between 70 and 100%, 5=healed).","definition_or_measurement_approach":"Categorical scoring of ulcer size change from baseline into six predefined categories (0–5) as described."}
• {"endpoint_text":"- Efficacy endpoints: Change in the ulcer dimension (cm2).","definition_or_measurement_approach":"Quantitative change in ulcer area measured in cm2 from baseline."}
• {"endpoint_text":"- Efficacy endpoints: Changes in the Wound Bed Score (WBS).","definition_or_measurement_approach":"Change from baseline in Wound Bed Score (WBS) as per WBS instrument."}
• {"endpoint_text":"- Efficacy endpoints: Changes in the wound pain intensity, as reported by the patient through a Visual Analogue Scale (VAS).","definition_or_measurement_approach":"Patient-reported wound pain intensity measured by Visual Analogue Scale (VAS); change from baseline assessed."}
• {"endpoint_text":"- Efficacy endpoints: Overall satisfaction assessment by the Investigator on the study product efficacy through a 5-points Likert Scale (1=very satisfied, 2=satisfied, 3=not satisfied nor unsatisfied, 4=not satisfied, 5=not satisfied at all).","definition_or_measurement_approach":"Investigator-rated satisfaction on efficacy using the specified 5-point Likert scale."}
• {"endpoint_text":"- Efficacy endpoint: Number of responders (responder = with ulcer area reduction ≥50%).","definition_or_measurement_approach":"Responder count defined as participants achieving ≥50% ulcer area reduction."}
• {"endpoint_text":"- Efficacy endpoint: The time to 50% wound reduction.","definition_or_measurement_approach":"Time (days) from baseline to achieving 50% reduction in wound area."}
• {"endpoint_text":"- Efficacy endpoint: Time to healing (if occurring).","definition_or_measurement_approach":"Time (days) from baseline to complete wound healing, if it occurs."}
• {"endpoint_text":"- Efficacy endpoint: Changes in Wound-QoL-14 questionnaire score.","definition_or_measurement_approach":"Change from baseline in patient-reported Wound-QoL-14 questionnaire score."}

Italy

Earliest CTIS Part Ii Submission Date

21-03-2026

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

25

Number Of Sites

1

Number Of Participants

52

Primary sponsor

Full Name

Hmg Biologics S.r.l.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy