CLINICAL STUDY | PATIENTS NEEDED
Leg Ulcers:
New Treatment Option for Patients
If you are suffering from leg ulcers, this study might be of interest to you – offering you the opportunity for treatment with a new therapeutic approach. Find out quickly and commitment-free with our questionnaire whether you can participate.
- Investigational medicine with a new mechanism of action
- Study approved by the relevant regulatory authorities and ethics committees
- Participation in clinics throughout the United Kingdom; no costs will be incurred
- Prof Mark Whiteley from The Whiteley Clinic Guildford is the coordinating investigator
- Investigational medicine with a new mechanism of action
- Study approved by the relevant regulatory authorities and ethics committees
- Participation in clinics throughout the United Kingdom; no costs will be incurred
- Prof Marc Whiteley from The Whiteley Clinic Guilford is the coordinating investigator
Dear patient,
If you suffer from leg ulcers, you know how much this condition can restrict your daily life. The mere sight of the wound can be concerning. Despite careful wound treatment, healing is often slow. There are only a few treatment options for those affected, and the usual therapies sometimes no longer help. This is why patients frequently look for new treatment options.
Development of a new treatment for leg ulcers
Research is making progress in the development of new therapies. We are pursuing a new treatment approach in the Leg Ulcer Study. In this clinical phase III trial for patients with leg ulcers, we are investigating the efficacy and tolerability of a new investigational medicine. It is a cell-based product with wound-healing and anti-inflammatory properties1 applied once to the wound’s surface. An initial study with 31 treated patients showed that the investigational medicine supports wound healing: In 70% of patients, the wound healed by an average of 82%, and in some cases, even healed completely.2
How well can the investigational medicine reduce inflammation and promote wound healing? The Leg Ulcer Study aims to answer questions like these. A total of 250 patients across Europe will take part in the study.
Leg ulcer patients can now participate
If you are suffering from leg ulcers, this study could be of interest to you – offering you the opportunity to receive treatment with the new investigational medicine. There are no costs incurred by participating in the study. You can learn more about the investigational medicine and the study on our website. Find out whether you can participate using our commitment-free questionnaire.
Thank you for your interest in the Leg Ulcer Study.
Prof Mark Whiteley
Coordinating Investigator UK
“The investigational medicine has a new mechanism of action to treat chronic venous leg ulcers.”
Prof Mark Whiteley
The Whiteley Clinic Guildford
STUDY SITES
Conducted by
Late-Breaking News
As Seen in Press
RHEACELL GmbH & Co. KG | 21.03.2024
Independent Expert Committee Acknowledges Treatment Potential of Novel Cell Therapy
RHEACELL receives positive vote from the IDMC for accelerated finalisation of a phase IIb study on ABCB5+ mesenchymal stromal cells in chronic venous wounds.
RHEACELL GmbH & Co. KG | 01.03.2024
German Dermatological Society: Novel Cell Therapy “opens new doors” for Treatment of Chronic Venous Ulcers
Prof Dr med Silke Hofmann (Wuppertal, Germany) describes in German presentation how mesenchymal stromal cells can help with therapy-resistant chronic venous ulcers.
RHEACELL GmbH & Co. KG | 06.10.2021
German Paul-Ehrlich-Institut Approves Novel Cell Therapy Derived from Skin!
RHEACELL receives national marketing authorisation for its cell therapy product in Germany for use in patients with chronic wounds.
RHEACELL GmbH & Co. KG | 19.10.2021
Widespread Condition Soon Curable? RHEACELL Takes Innovative Therapeutic Approach with Novel Cell Therapy
Heidelberg-based biopharmaceutical company begins follow-up study on previously incurable chronic venous ulcers.
RHEACELL GmbH & Co. KG | 08.09.2020
Chronic Venous Ulcers: Therapy Alleviates the Fear of Non-Healing Wounds
Heidelberg-based biopharmaceutical company confirms the efficacy and safety of a new investigational medicine in CVU patients.
RHEACELL GmbH & Co. KG | 25.08.2020
Diabetic Foot Ulcer: Clinical Study Offers New Hope to Patients
Heidelberg-based biopharmaceutical company confirms the efficacy and safety of a new investigational medicine with a completed IIa study.
RHEACELL GmbH & Co. KG | 30.07.2020
RHEACELL Three Times Successful with Study Results in Chronic and Incurable Diseases
Biopharmaceutical company concludes three clinical patient studies for severe, chronic conditions.
CRITERIA
Can You Participate in the Study?
The clinical Leg Ulcer Study targets adults with chronic leg ulcers.
You are eligible to participate in the clinical trial if:
You are 18 years or older.
Your doctor has diagnosed you with venous leg ulcers.
Wound size is between 1 and 25 cm².
You are not eligible to participate in the study if:
You suffer from an acute deep vein thrombosis or require treatment for Peripheral Arterial Disease (PAD).
You are scheduled to receive surgery on your affected leg.
You have had cancer in the last 5 years.
PARTICIPATION
How to Participate in the Clinical Trial
STEP
1
Step 1: Get information
Take the time to learn the details of the study on this website. On the subpages, you will find details about the Leg Ulcer Study and the frequently asked questions.
STEP
2
Step 2: Fill in the questionnaire
Answering the questionnaire will tell you whether you are eligible to participate. Afterward, our Patient Information Service will clarify the next steps for you.
STEP
3
Step 3: Make an appointment
If you are interested in participating, you can talk to a study doctor commitment-free. Only after your appointment at the study site will you decide with your attending doctor whether to participate.
AT A GLANCE
What to Expect During the Study Phase?
Participating in the study incurs no cost to you. Travel costs will be reimbursed.
1
administration
of the investigational medicine.
18
months
you will be followed up.
17
visits
take place at the study site.
2
blood samples
are taken
1
administration
of the investigational medicine.
18
months
you will be followed up.
17
visits
take place at the study site.
2
blood samples
are taken.
STUDY SITES
This Is Where the Leg Ulcer Study Is Conducted
12
countries
>70
sites
250
participants
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More InformationFAQ
Frequently Asked Questions
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.
Initial data from a single-arm multicentre Phase I/IIa study in patients with leg ulcers support the efficacy and safety of allo-APZ2-CVU. The study comprised 31 treated patients with chronic venous leg ulcers. Within 12 weeks, wound size shrunk by an average of 82% in 70% of the patients. In 6 patients, the wound had even entirely closed after 12 weeks. None of the patients experienced any serious adverse events.3 In a follow-up study, the efficacy and safety of the cell therapy was further investigated in three different dose groups. The study was a randomised, placebo-controlled, blinded phase IIb study. As part of an interim evaluation, in which an independent expert committee was given an insight into the data collected from the first 102 patients treated, the committee recommended continuing the study with the most effective dose group. No safety concerns were expressed. A final evaluation is currently still pending. In addition, the cells have already been tested in other indications. Almost 200 patients have been treated with the cells to date.
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 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.
- Test group: The investigational medicine allo-APZ2-CVU
- Placebo group: A placebo of the investigational medicine allo-APZ2-CVU
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.
Are You Interested in The
Leg Ulcer Study?
Find out now if you can participate in the study with our commitment-free questionnaire.
- Vander Beken S et al. Stem Cells. 2019
- Kerstan A et al. JID Innov. 2022
- Kerstan et al. JID Innovations 2022