A two-part study: open label, dose escalation phase aimed to evaluate the safety and tolerability of two different doses of allogeneic fibroblasts for the treatment of chronic refractory wounds and identifying the best dose for subsequent cohort expansion phase aimed to assess efficacy and confirm safety and tolerability

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hmg Biologics S.r.l.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2026-04-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

HMG Biologics S.r.l.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Escalation phase:
- To assess safety and tolerability of a single application of two different strengths of allogeneic fibroblasts
- To identify the best strength to test in the following expanded part of the trial.

Expansion phase:
To assess the efficacy of a single application of a single strength of allogeneic fibroblasts.

Secondary objectives 2

1. Dose escalation phase: To assess efficacy of a single application of two different strengths of allogeneic fibroblasts.
2. Expansion phase: To assess safety and tolerability of a single application of a single strength of allogeneic fibroblasts.

Conditions and MedDRA coding

Refractory wounds

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Properly executed written informed consent form (ICF).
2. Males and females aged ≥18 years, inclusive, at the screening visit.
3. BMI between 18.5 kg/m2 and 40 kg/m2, inclusive, and weight of at least 45 kg at screening.
4. Negative pregnancy test.
5. 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.
6. Male participants with female partners of child-bearing potential must be willing to use highly effective contraception methods
7. 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.
8. 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.
9. Willing and able to comply with all study requirements, schedules and procedures.

Exclusion criteria 10

1. 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.
2. Active alcohol, medicine or substance abuse within the last 2 years.
3. Acute ulcer (<3 months).
4. Impaired nutritional status (BMI <18,5, Serum albumin <2.4 g / dL, weight loss >10% of ideal weight in the last 3 months).
5. 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
6. Breast-feeding and pregnant females as per positive urine β-HCG.
7. 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
8. 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)
9. Patients with known allergy to collagen, streptomycin, penicillin and/or products of bovine origin.
10. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 12

1. 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).
2. Safety endpoints: Changes from baseline in physical examination, vital signs, 12-lead ECG, blood and urine analyses.
3. 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).
4. 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).
5. Efficacy endpoints: Change in the ulcer dimension (cm2).
6. Efficacy endpoints: Changes in the Wound Bed Score (WBS).
7. Efficacy endpoints: Changes in the wound pain intensity, as reported by the patient through a Visual Analogue Scale (VAS).
8. 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).
9. Efficacy endpoint: Number of responders (responder = with ulcer area reduction ≥50%).
10. Efficacy endpoint: The time to 50% wound reduction.
11. Efficacy endpoint: Time to healing (if occurring).
12. Efficacy endpoint: Changes in Wound-QoL-14 questionnaire score.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hmg Biologics S.r.l.

Sponsor organisation

Hmg Biologics S.r.l.

Address

Corso Vittorio Emanuele II 30

City

Milan

Postcode

20122

Country

Italy

Scientific contact point

Organisation

Hmg Biologics S.r.l.

Contact name

Massimo Costa

Public contact point

Organisation

Hmg Biologics S.r.l.

Contact name

Massimo Costa

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications