Overview Clinical Trials

By implementing and participating in different research projects, we support the research of ABCB5+ stem cells. The aim is to develop stem cell-based pharmaceuticals.

The data obtained in these projects are being transferred into clinical trials by RHEACELL GmbH & Co. KG, a subsidiary of TICEBA GmbH. These trials serve the clinical development of the stem cell-based drugs produced by TICEBA as a pharmaceutical manufacturer (§13 AMG) with the goal of subsequent market authorization.


Current Clinical Trials

Germany

Worldwide


General Information about Clinical Trials

The clinical trials performed by RHEACELL are subject to generally accepted medical and ethical standards. In order to achieve a comprehensive patient population, trials are designed as multicentric trials conducted at specialist hospitals in Germany and, in part, additional European countries and USA. A very close interaction with the relevant German (PEI), European (EMA), and US authorities (FDA) is essential.

Within preclinical development, safety and local tolerability of the product has been demonstrated in a comprehensive study program (Tappenbeck et al., 2019). In the clinical trials the investigational products are tested for efficacy and safety in a specific group of patients. Each trial is approved by the relevant national authorities and ethics committees. All trials meet the ethical principles of the Declaration of Helsinki by the World Medical Association and the Guidelines for Good Clinical Practice (GCP).

The clinical trial designs of RHEACELL can be viewed in a publicly available clinical trial registries at clinicaltrials.gov and clinicaltrialsregister.eu.

News
Article about our study with limbal stem cells

On the website of the Harvard Stem Cell Institute you will find the following news release about the ongoing clinical trial conducted by our daughter company RHEACELL in patients suffering from limbal stem cell deficiency: Restoring vision: A stem cell therapy for cornea regeneration reaches the clinical-trial stage.

Clinical Trial - EB

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and several European competent national regulatory authorities. The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) for the treatment of EB.

Clinical Trial - LSCD

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and the German regulatory authority (Paul Ehrlich Institute). The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) and Fast Track designation from the FDA for the treatment of LSCD.

Safety

In a comprehensive preclinical study program, safety and local tolerability of ABCB5+ MSCs following subcutaneous, intramuscular and intravenous application has been demonstrated (Tappenbeck et al., 2019).

Newsletter