STUDY
The Leg Ulcer Study at a Glance
OPPORTUNITIES
5 Reasons to Participate in the Study
The Leg Ulcer Study aims to determine how well the investigational medicine works and how tolerable it is. Participating provides affected patients with new opportunities.
OPPORTUNITIES
5 Reasons to Participate in the Study
The Leg Ulcer Study aims to determine how well the investigational medicine works and how tolerable it is. Participating provides affected patients with new opportunities.
You have the chance to receive a new potential medication now.
The investigational medicine may work better than the current therapy.
At every visit, your wound will be treated according to the current guidelines. Study-related costs and travel expenses will be covered by the sponsor of the study.
Medical professionals will closely monitor you throughout the stud.
By participating in the study, you are supporting medical research in developing new medicines for leg ulcers, which could benefit patients in the future.
Possible risks
As with all clinical trials, participation may involve potential risks. The investigational medicine may not work or not work as desired, or unexpected events may occur. For this reason, you will be monitored closely. All participants will be allocated to either the control or experimental group. Therefore, there is the possibility you will only receive a placebo, i.e., a sham drug without an active substance. Before participating, you will receive thorough information by a study doctor. They will explain possible risks in detail to you.
INVESTIGATIONAL MEDICINE
The Mechanism of Action at a Glance
The investigational medicine allo-APZ2-CVU consists of ABCB5-positive stromal cells. They are extracted from skin tissue donations, cultivated in the lab, and then applied once to the wound as a highly pure, active cell population.
What Is ABCB5 and Why Are ABCB5-Positive Stromal Cells Used?
In 2003, a new and previously unidentified group of mesenchymal stromal cells (MCSs) in the skin was described, possessing ABCB5 protein on their surface. These cells act immunomodulatory and anti-inflammatory, making them unique candidates for treating severe immune- and inflammation-related diseases. Their properties can also promote wound healing in leg ulcers.
Without active ingredient
Possible effect of allo-APZ2-CVU
Mechanism of Action Overview
1. M1 macrophages are predominantly present in chronic wounds.
2. M1 macrophages catch and kill bacteria but also produce pro-inflammatory signalling substances. These prevent the body from activating the regeneration process.
3. Applying ABCB5-positive stromal cells creates an anti-inflammatory environment.
4. Now, M2 macrophages, which are anti-inflammatory and support tissue healing, dominate.
5. Better conditions have been created to promote wound healing.
How do ABCB5-positive MCSs change the ratio of M1 to M2 macrophages?
In 2003, a new and previously unidentified group of mesenchymal stromal cells (MCSs) in the skin was described, possessing ABCB5 protein on their surface. These cells act immunomodulatory and anti-inflammatory, making them unique candidates for treating severe immune- and inflammation-related diseases. Their properties can also promote wound healing in leg ulcers.
PROCEDURE
This Is How the Leg Ulcer Study Works
1. Inform yourself & check participation
The most important information about the Leg Ulcer Study is on this website. Take your time to read through everything. Then, you can use the commitment-free questionnaire to check whether you meet the most important study participation criteria and are generally eligible to participate.
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2. Book an appointment
If your responses make you eligible, you can leave us your contact details at the end of the questionnaire. Our Patient Information Service will then contact you personally in a commitment-free telephone call. We will answer further questions and clarify the next steps with you. We can also provide information for your treating doctor if you wish.
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3. First visit to the study site
You will meet the study doctor at your first appointment at the study site. They will explain the study details to you thoroughly and check once again whether you can participate in the study using your medical history and medicine intake. You will receive all the information in writing and can read it when you have time. Once you have understood everything and decided to participate, you and your study doctor can sign the consent form.
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4. Preliminary examination
With the written consent, the preparation for study participation begins as a preliminary examination: Your study doctor conducts a series of tests to rule out any medical parameters that might contraindicate study participation.
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5. Treatment phase
During the treatment phase, you will be randomly allocated to receive either the investigational medicine or a placebo (a sham drug that looks identical to the investigational medication but doesn’t contain any active ingredient). The investigational medication or the placebo is applied only once and follows the same principle.
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6. Medication-free follow-up & conclusion
Over the next 16.5 months after treatment, 14 follow-up visits will take place at the study site. The wound will be photographed and checked for infection or pain. In addition, medical professionals will dress your wound following the guidelines. 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.
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SPONSOR
About RHEACELL
The investigational medicine allo-APZ2-CVU was developed by the German company RHEACELL. RHEACELL develops unique stem cell therapies, offering new treatment options to patients with no alternative solutions. The company is dedicated to developing therapies for severe chronic and rare hereditary diseases that have previously been resistant to treatment.
Are you interested in the
Leg Ulcer Study?
Find out now if you can participate in the study with our commitment-free questionnaire.