FAQ
The investigational medicine “allo-APZ2-CVU” contains ABCB5-positive mesenchymal stromal cells (MSC) obtained from a skin tissue donation and multiplied. This highly purified cell population is applied once to the surface of the affected wound. The application transforms the inflammatory environment of the wound tissue into an anti-inflammatory environment, which is intended to create better conditions for wound healing.
The investigational medicine or placebo is only applied superficially once. Beforehand, the wound must be dressed with a sharp spoon or a curette under local anaesthetics. After treatment, the wound is sealed with a film plaster. This plaster is crucial for the survival of the stromal cells. After 1 to 2 days, the plaster is replaced with another wound dressing at the first dressing change.
This depends on the type of medication. If you are currently taking medications that affect wound healing, such as systemic immunosuppressants, cytotoxic drugs or systemic cortisone preparations, this could possibly lead to exclusion from participation in the study.
The treatment of the wound with active wound care products must also be paused 14 days before the administration of the trial medicine or placebo.
Moreover, you cannot participate in the Leg Ulcer Study if you are currently participating in another study.
The primary purpose of this study is to assess the efficacy and tolerability of the investigational medicine allo-APZ2-CVU for treating chronic venous leg ulcers using 250 patients.
The trial is in phase III, and the investigational medicine is being tested on 250 patients throughout Europe, focusing mainly on investigating the efficacy and safety of the investigational medicine. It is a randomised, placebo-controlled, multicentre and double-blind pivotal study.
Placebo-controlled means that the effect of the investigational medicine is tested compared to a placebo. A placebo looks precisely like the tested medicine but contains no active ingredient.
Randomised means chance decides whether you get the investigational medicine or a placebo, just like tossing a coin. This is to avoid any bias in the allocation process. Randomisation takes place at the beginning of the treatment phase.
Double-blind means that neither the members of the study team nor you will know which treatment you will be assigned to. So, no one can tell you whether you will get a placebo or an active ingredient. The purpose of “blinding” in clinical trials is to prevent trial team members or participants from influencing the results. For example, merely expecting the medicine to help can influence what a participant says about their symptoms.
Multicentre means the clinical trial is conducted at several study sites. This allows researchers to recruit participants from different geographic regions and minimise participants’ travel expenses.
Dose-finding studies are studies in which different doses of the investigational medicine are also tested against each other. This makes it possible to determine which dose works best or is associated with the least side effects. Dose-finding studies are usually phase I or phase II studies. In the allo-APZ2-CVU-III study, one dose of the investigational medicine that proved to be the most effective dose in the previous study is tested compared to a placebo.
All new medicines must first be tested in clinical trials before they can be released for general treatment. These studies test the new medication’s efficacy and tolerance under strict regulations, with participants closely monitored by doctors. For patients, participating in clinical trials means they can receive a new treatment for their disease even before it is officially approved.
The clinical trials are divided into three phases:
Phase I: A small group of healthy volunteers receives the investigational medicine for the first time. Administration starts with a very low dose, which is then carefully increased. The aim is to investigate tolerability and safety.
Phase II: A slightly larger group of patients receives the investigational medicine. In addition to safety and tolerability, efficacy is tested here.
Phase III: The investigational medicine is tested in large, often international, clinical trials involving several hundred to several thousands of patients. The focus of testing is its safety, tolerability, and efficacy. Based on the results of all these studies, marketing authorisation can be applied for the investigational medicine. If successful, it becomes an officially approved medicine that is now available to patients.
Phase IV: Sometimes, researchers append an additional study phase after the medicine’s market approval. This way, more information can be gained, e.g., about side effects, clinical benefits, and safe use in everyday clinical practice.
The clinical trial has already started and is expected to run until winter 2025. Participation is therefore possible from now on. With our questionnaire, you can simply check commitment-free whether you are eligible to participate in the clinical trial.
The participants in the Leg Ulcer Study are randomly assigned to one of the 2 groups in equal numbers. Therefore, one half receives the investigational medicine, and the other gets a placebo.
Neither you, your study doctor, nor any other person involved in the study will be told which treatment you are getting. This is also called “blinding”.
You may be unblinded in certain situations, such as a medical emergency. This means that your study doctor or the study team can determine whether you have received the investigational medicine or placebo.
The Leg Ulcer Study is conducted across Europe at a total of >70 sites. In the United Kingdom, 7 sites participate. These are renowned study sites in all of the UK.
With our questionnaire, you can easily check commitment-free whether you are generally eligible for the study.
In total, your participation in the Leg Ulcer Study will last up to 18 months. Participation requires 17 visits (2 for the screening phase, 15 for administration and follow-up) to the study site. The investigational medicine allo-APZ2-CVU or the corresponding placebo will only be administered once. In certain cases, selected follow-up visits may also take place at home. If you agree to this, someone from the study staff will come to your home on the agreed date and performs the wound care and photo documentation on site.
No, as part of the Leg Ulcer Study, you will visit the study site on an outpatient basis.
No, you do not have to pay anything to participate in these studies. The study sponsor bears the costs of the medication administered in the study and those of all examinations and laboratory analyses.
Your health insurance does not influence your participation in the Leg Ulcer Study. Costs related to examinations and treatments of the study will not be billed to your health insurance, as the sponsor covers all clinical trial costs. In addition, RHEACELL is obligated to arrange participant insurance. It covers possible risks of study participation.
You will be reimbursed for your travel expenses.
After the study, if necessary, you can continue to be cared for by your study doctor to utilise all available treatment options.
At the end of the study, your study doctor can ask for the study results. If you are interested, please get in touch with them.
If you contact the Patient Info Service, you can obtain further information about the Leg Ulcer Study for your doctor. Talk to your study doctor if your doctor has any questions during your participation in the study.
Yes, you have the right to terminate your participation at any time without having to give a reason. This will not cause you any disadvantages concerning further medical care.
However, you should inform your study doctor immediately about your decision. It is also essential to report any adverse events that may have occurred during the clinical trial so that appropriate conclusions may be drawn for you and other study participants.
If it is necessary for your safety, the study doctor may withdraw you from the study. In this case, the study team will discuss possible further treatment with you.
RHEACELL, the sponsor of the clinical trial, also reserves the right to stop the Leg Ulcer Study prematurely. For example, this may be the case if an interim evaluation shows that the treatment is ineffective.
The privacy of persons involved in a clinical trial is protected to the highest degree. For this purpose, your data will be pseudonymised. This means that the study doctor collects your information and labels it with a code. In this way, your data is processed without any information that might reveal your identity. Only authorised persons, such as the study doctor, can access the list of patient names and the corresponding codes.
The Leg Ulcer Study is funded by the company RHEACELL. The research company specialises in developing unique stem cell therapies for severe chronic and rare hereditary diseases that have so far proven to be resistant to treatment.
RHEACELL has commissioned Trials24 GmbH to develop and provide the website, the online questionnaire and the patient information service for the Leg Ulcer Study. Trials24 GmbH is based in Munich, Germany. It is a specialised service provider and supports pharmaceutical companies in their search for participants for clinical trials to make innovative therapies available to patients more quickly.
Find out now if you can participate in the study with our commitment-free questionnaire.
1. Kerstan et al. JID Innovations 2022
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