Heidelberg-based biopharmaceutical company is conducting a follow-up study with highly purified stem cells (AMESANAR®) for the treatment of previously incurable chronic ulcers.
Heidelberg, 19. October 2021 – More than 80,000 people in Germany suffer from chronic venous ulcers (CVU). Triggered by venous insufficiency, wounds and weeping ulcers can develop that may not heal for years. Severely affected patients experience intense pain every day. Until now, there has been no effective treatment – but this could change soon.
A first successfully completed clinical trial (JID Innovations, ahead of print) with a limited number of patients confirmed the safety of the stem-cell agent. Initial data also showed the therapy to be effective. Germany’s Federal Institute for Vaccines and Biomedicines (Paul-Ehrlich-Institut) has now approved a follow-up study to investigate the efficacy in a large-scale population. The first patient in this follow-up study has already been treated.
In addition, the company recently received the national marketing authorization (§ 4b German Medicinal Products Act) for the treatment of these patients with AMESANAR®. This means that a much larger group of patients can finally be helped.
“These approvals are not only of great significance for those affected, but they are also an important milestone for a new product class in a relatively young research area.” says Dr. Ganss, physician and CEO of RHEACELL.”
Stem-cell-based therapies are becoming increasingly important, especially in incurable diseases. These approvals by Germany’s Federal Institute for Vaccines and Biomedicines (Paul-Ehrlich-Institut) are a clear signal of support for the development of cell-based drugs.
RHEACELL is a pioneer in stem-cell-based drug development. In addition to non-healing chronic venous wounds and non-healing diabetic foot wounds, its research focuses on serious and rare diseases such as epidermolysis bullosa (butterfly disease) which mainly affects children.
Its goal is to advance medical progress while maintaining the highest quality and safety standards in order to help people for whom there was previously no hope of a cure.
CVUs occur as a result of insufficient venous return in the lower extremities predominantly caused by venous reflux or obstruction of the leg veins. Increased venous pressure causes impaired microcirculation which, through a cascade of pathophysiological events, eventually leads to tissue breakdown and the development of painful wounds. Until now, there is no conclusive evidence that dressings, topical or systemic agents are effective in promoting the healing of venous ulcers. For severely affected patients, surgery to remove the cause of the increased venous pressure is often the only remaining option.