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CLINICAL STUDY TO TEST STEM CELLS FOR THE TREATMENT OF LONG-TERM, NON-HEALING VENOUS LEG ULCERS
EU CTIS ID: 2024-512720-11-00
What this study is testing
The aim of this clinical trial is to investigate the efficacy (by monitoring complete wound closure) and safety (by monitoring AEs) of the IP allo-APZ2-CVU, administered topically on target wounds of patients with therapy-resistant non-healing CVU compared to placebo.
- Therapeutic confirmatory (Phase III)
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
- Patients at least 18 years old
- Chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler-Duplex sonography, ankle brachial index (ABI, 0.9-1.3; optionally, in case ABI > 1.3 or not measurable: toe brachial index (TBI) ≥0.7)), physical examination and dermatological review
- Wound size at V1 and V2 between 1 and 25 cm2 as measured by standardized photography
- If patients have 2 or more ulcers at the same extremity, the target ulcer (defined at V2) has to be separated from the other ulcers with a bridge of epithelialized skin at least 1 cm wide
- Body mass index between 15 and 50 kg/m²
- Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures
You likely can't join if
- Evidence of the ulcer extending to the underlying muscle, tendon, or bone
- Any malignancy within the past 5 years, excluding successfully treated carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin without evidence of metastases
- Pregnant or lactating women
- Known hypersensitivities to the active substance or to any of the excipients in the IP or the placebo
- Surgical procedure affecting the CVU, such as bypass or mesh graft performed within two months prior to Visit 1
- Current or previous (within 30 days of enrollment) treatment with another IP, or participation in another clinical trial, including follow-up phase
See the full eligibility criteria
- Patients at least 18 years old
- Chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler-Duplex sonography, ankle brachial index (ABI, 0.9-1.3; optionally, in case ABI > 1.3 or not measurable: toe brachial index (TBI) ≥0.7)), physical examination and dermatological review
- Wound size at V1 and V2 between 1 and 25 cm2 as measured by standardized photography
- If patients have 2 or more ulcers at the same extremity, the target ulcer (defined at V2) has to be separated from the other ulcers with a bridge of epithelialized skin at least 1 cm wide
- Body mass index between 15 and 50 kg/m²
- Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures
- Women of childbearing potential must have a negative urine pregnancy test at Visit 1
- During the course of the clinical trial women of childbearing potential and their male partners must be willing to use highly effective contraceptive methods as defined in the EMA CTCG “Recommendations related to contraception and pregnancy testing in clinical trials", Version 1.2.
- Evidence of the ulcer extending to the underlying muscle, tendon, or bone
- Any malignancy within the past 5 years, excluding successfully treated carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin without evidence of metastases
- Pregnant or lactating women
- Known hypersensitivities to the active substance or to any of the excipients in the IP or the placebo
- Surgical procedure affecting the CVU, such as bypass or mesh graft performed within two months prior to Visit 1
- Current or previous (within 30 days of enrollment) treatment with another IP, or participation in another clinical trial, including follow-up phase
- Previous participation in this clinical trial (except for screening failures due to an inclusion or exclusion criterion)
- Employees of the sponsor, or employees or relatives of the investigator(s)
- Uncontrolled Diabetes mellitus i.e. Hemoglobin A1c (HbA1c) >9.0% (75 mmol/mol) (measured by blood test)
- Peripheral Artery Disease including claudication with need of treatment or intervention
- Acute deep vein thrombosis diagnosed within 30 days before V1, or untreated deep vein thrombosis
- Wounds showing size reduction of more than 40% at Visit 2 compared to Visit 1
- Patients with known hypersensitivity and/or clinical contraindications to the compression systems used in the clinical trial, or inability/unwillingness to tolerate leg ulcer compression systems
- Acute wound infection of ulcer requiring treatment as judged clinically
- Current use of medications that are known to influence wound healing i.e. systemic immunosuppressives, cytotoxic medicinal products, systemic steroids (above Cushing-threshold level) at investigator´s discretion
- Patients who, in the opinion of the investigator, for any reason are unable or unwilling to complete the trial per protocol (e.g. alcohol or substance abuse, not mobile, short life expectancy) or there is an evidence of any other medical condition (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the patient’s compliance, or place the patient at high risk of complications related to the treatment
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
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.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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.