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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
EU CTIS ID: 2025-522647-17-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Properly executed written informed consent form (ICF).
- Males and females aged ≥18 years, inclusive, at the screening visit.
- BMI between 18.5 kg/m2 and 40 kg/m2, inclusive, and weight of at least 45 kg at screening.
- Negative pregnancy test.
- 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.
- Male participants with female partners of child-bearing potential must be willing to use highly effective contraception methods
You likely can't join if
- 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.
- 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
- Active alcohol, medicine or substance abuse within the last 2 years.
- Acute ulcer (<3 months).
- Impaired nutritional status (BMI <18,5, Serum albumin <2.4 g / dL, weight loss >10% of ideal weight in the last 3 months).
- 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
See the full eligibility criteria
Who can join
- Properly executed written informed consent form (ICF).
- Males and females aged ≥18 years, inclusive, at the screening visit.
- BMI between 18.5 kg/m2 and 40 kg/m2, inclusive, and weight of at least 45 kg at screening.
- Negative pregnancy test.
- 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.
- Male participants with female partners of child-bearing potential must be willing to use highly effective contraception methods
- 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.
- 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.
- Willing and able to comply with all study requirements, schedules and procedures.
What rules you out
- 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.
- 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
- Active alcohol, medicine or substance abuse within the last 2 years.
- Acute ulcer (<3 months).
- Impaired nutritional status (BMI <18,5, Serum albumin <2.4 g / dL, weight loss >10% of ideal weight in the last 3 months).
- 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
- Breast-feeding and pregnant females as per positive urine β-HCG.
- 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
- 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)
- Patients with known allergy to collagen, streptomycin, penicillin and/or products of bovine origin.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.