RHEACELL, a leading biopharmaceutical stem cell company based in Heidelberg, Germany, has announced a strategic partnership with AOP Health to commercialize innovative stem cell therapies for epidermolysis bullosa (EB) and chronic venous wounds across Europe. The collaboration aims to accelerate the delivery of breakthrough treatments to patients with rare diseases who currently have limited therapeutic options.
Partnership Advances Phase 3 Development
Building on positive Phase 2 results and favorable regulatory feedback, the partnership supports two ongoing Phase 3 clinical trials. The companies anticipate submitting their first application to the European Medicines Agency (EMA) in 2026, marking a significant milestone in bringing these therapies to market.
"This partnership marks a significant milestone for RHEACELL and the further development of our stem cell medication programs," said Dr. med. Christoph Ganss, CEO of RHEACELL. "Collaborating with an established partner like AOP Health to commercialize our stromal cell medications will allow us to bring our innovative therapies to the European patients faster and more efficiently."
Addressing Critical Unmet Medical Needs
The partnership focuses on two distinct patient populations facing significant treatment challenges. Epidermolysis bullosa, known as "butterfly children's disease," affects approximately 500,000 people worldwide. This congenital genetic disorder causes skin fragility comparable to a butterfly's wing, where even minor mechanical stress or friction can cause blistering and painful chronic wounds.
Dr. Martin Steinhart, CEO of AOP Health, emphasized the mission-driven nature of the collaboration: "Our mission is to provide patients with rare diseases access to urgently needed therapeutic innovation. This partnership with stem cell pioneer RHEACELL enables us to jointly bring new treatment options to patients living with chronic venous wounds or Epidermolysis bullosa, who currently have limited or no treatment options."
Novel Therapeutic Approach
RHEACELL's proprietary therapy utilizes ABCB5+ mesenchymal stromal cells as a purified active ingredient. The treatment distinguishes itself through systemic administration to stimulate both internal and external wound healing, contrasting with other approaches that focus primarily on local skin applications.
"RHEACELL's approach of administering stromal cells systemically to stimulate internal and external wound healing distinguishes it from other approaches that focus primarily on local applications on the skin," noted Dr. Rainer Riedl, founder and chairman of DEBRA Austria. "We are thrilled to follow the ongoing clinical development."
Clinical Validation and Expert Support
The therapeutic approach has garnered support from leading medical experts in the field. Univ.-Prof. Dr. Johann Bauer, Head of EB Research at the EB-Haus Austria, the world's first specialized clinic for 'butterfly children,' highlighted the promise of the regenerative approach: "In treating Epidermolysis bullosa, we have had few therapeutic options to date. This lack of treatment options adds an additional burden on those affected. From a medical perspective, the concept of regenerative, anti-inflammatory cell therapy is a promising approach."
Expanding Treatment Scope
Beyond epidermolysis bullosa, the partnership addresses chronic venous wounds, which represent the most common type of leg ulcers, accounting for 60-80% of cases. These wounds result from prolonged venous insufficiency and primarily affect older adults, developing due to poor blood flow in the veins leading to tissue breakdown in the lower extremities.
Company Backgrounds
RHEACELL brings more than 20 years of experience as an integrated biopharmaceutical stem cell company, currently conducting approval trials in both the EU and US. The company focuses on innovative stem cell therapies for patients suffering from severe immune- and inflammation-related diseases.
AOP Health, established in 1996, operates as a global enterprise group with Austrian roots, specializing in developing innovative solutions for unmet medical needs in rare diseases and intensive care medicine. The company has established itself internationally as a pioneer in integrated therapy solutions, operating worldwide through subsidiaries and partner networks.
The patient organization DEBRA, which describes EB as "the worst disease you've never heard of," was founded in 1995 to facilitate exchange and provide support to people living with EB. DEBRA Austria's key initiative, the EB-Haus Austria, located at the Salzburg University Hospital campus, serves as a center of excellence for epidermolysis bullosa treatment and research.
