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Study on the Effectiveness and Safety of allo-APZ2-CVU for Healing Chronic Venous Ulcers in Patients with Therapy-Resistant Wounds

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for chronic venous ulcers (CVU), which are long-lasting wounds that occur due to poor blood circulation in the veins of the legs. The treatment being tested is called allo-APZ2-CVU, a type of cell therapy that uses special cells derived from skin to help heal these stubborn wounds. The study will compare the effects of three different doses of this treatment to a placebo to see how well it helps in closing the wounds and ensuring safety for the patients.

The main goal of the study is to observe how effectively the treatment can close the wounds and to monitor any side effects that may occur. Participants will receive the treatment applied directly to their wounds. The study will take place over several weeks, with regular follow-up visits to check on the progress of wound healing and to assess any changes in the size of the wound, the time it takes to heal, and the quality of healing. The study will also evaluate the impact of the treatment on the participants' quality of life and any pain they experience.

By participating in this study, researchers aim to gather valuable information on the potential benefits and safety of allo-APZ2-CVU for individuals suffering from chronic venous ulcers. This could lead to new treatment options for those who have not responded to existing therapies. The study is designed to ensure that all participants are closely monitored throughout the process to ensure their well-being and to collect accurate data on the treatment's effectiveness.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, presence of a chronic venous ulcer, and other health parameters.
Written informed consent is required before any trial procedures begin.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the size and condition of the target ulcer using standardized photography.
A blood pregnancy test is performed for women of childbearing potential.
Step 3
Treatment administration
The investigational medicinal product, allo-APZ2-CVU, is administered topically on the target wound.
The treatment involves a cutaneous suspension applied directly to the skin.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor wound healing progress and any adverse events.
Wound size changes are assessed at each visit, and complete wound closure is evaluated.
Step 5
Quality of life and pain assessment
Quality of life is assessed using the Wound-Quality of Life Questionnaire at specific visits.
Pain levels are measured using a numerical rating scale during follow-up visits.
Step 6
Final evaluation
The primary endpoint is complete wound closure at Week 18, persisting for at least two weeks.
Secondary endpoints include the duration of wound closure, recurrence, and overall quality of wound healing.

Who can join the trial?

8 criteria

Male or female patients who are at least 18 years old.
Have a chronic venous leg ulcer, which is a sore on the leg that doesn't heal within 3 months despite treatment or hasn't fully healed within 12 months. It should be located on the lower leg or ankle and not have been present for more than 15 years. This condition is diagnosed using tests like Doppler or duplex sonography (which are imaging tests to check blood flow), ankle brachial index (ABI) (a test comparing blood pressure in the ankle and arm), physical examination, and skin review.
The size of the ulcer should be between 1 and 50 square centimeters, measured by a photo taken during the screening visit.
If there are 2 or more ulcers on the same leg, the main ulcer (target ulcer) should be at least 1 centimeter away from other ulcers, with healthy skin in between. The largest ulcer is usually chosen as the target ulcer unless the study doctor decides otherwise.
Have a body mass index (BMI) between 15 and 50 kg/m². BMI is a measure of body fat based on height and weight.
Understand the study and agree to participate by signing a written consent form before any study procedures begin.
Women who can have children must have a negative blood pregnancy test at the first visit.
Women who can have children and their partners must agree to use highly effective birth control methods during the study.

Who cannot join the trial?

8 criteria

Patients who are not within the specified age range for the study.
Patients who have medical conditions other than chronic venous ulcers (long-lasting wounds on the legs due to poor blood flow).
Patients who are not able to follow the study procedures or instructions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study medication.
Patients with severe health conditions that might interfere with the study.
Patients who are unable to give informed consent (agree to participate after understanding the study).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
HELIOS Kliniken Schwerin GmbH
Schwerin, Germany
Verified
HELIOS Klinikum Emil von Behring GmbH
Berlin, Germany
Verified
Klinikum Nuernberg
Nürnberg, Germany

Trial locations

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Investigated drugs

allo-APZ2-CVU is an investigational medication being studied for its potential to help heal chronic venous ulcers that have not responded to other treatments. It is applied directly to the wound to see if it can improve wound closure and promote healing. The trial is also monitoring for any side effects to ensure the medication is safe for use.

Allogeneic Skin-Derived Abcb5-Positive Dermal Mesenchymal Stromal Cells

What is already known about the treatment

allo-APZ2-CVU – This medication is administered topically, meaning it is applied directly to the skin on the target wounds. It is currently being studied in a Phase IIb clinical trial to assess its effectiveness and safety for treating chronic venous ulcers, which are wounds that do not heal easily. The main therapeutic indication for allo-APZ2-CVU is to promote wound healing in patients with therapy-resistant chronic venous ulcers. At the molecular level, the mechanism of action involves enhancing the body's natural healing processes, although specific details are still under investigation. It is classified pharmacologically as an investigational medicinal product, as it is still undergoing clinical trials to determine its potential benefits and risks.

Investigated diseases

Chronic Venous Ulcers – Chronic venous ulcers are long-lasting sores that typically occur on the legs due to poor blood circulation in the veins. They develop when the veins in the legs fail to return blood efficiently to the heart, causing increased pressure and fluid buildup. This pressure can damage the skin and underlying tissue, leading to the formation of an ulcer. These ulcers are often painful and can become larger if not properly managed. They may also be accompanied by swelling, itching, and changes in skin color around the affected area. The healing process can be slow, and the ulcers may recur if the underlying venous issues are not addressed.