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General Information about Clinical Trials

As a research company in the field of stem cell-based medicines it is the goal of RHEACELL GmbH & Co. KG to develop innovative therapeutic options. An integral part of the research program of RHEACELL is the development of new therapeutic areas and the implementation of the data obtained in clinical trials for subsequent market authorization.

The stem cell-based medication (investigational product) is manufactured by TICEBA GmbH, the parent company of RHEACELL, according to §13 AMG. Safety and local tolerability of the product have been demonstrated in a comprehensive preclinical study program (Tappenbeck et al., 2019).

Current Clinical Trials

Germany: Worldwide:

General Information

The clinical trials performed by RHEACELL are subject to generally accepted medical and ethical standards. The trials are designed as multicentric trials at German specialist hospitals in the relevant indication by medical experts in order to achieve a comprehensive patient population. Further trials are currently planned and prepared in additional European countries and in the United States. A very close interaction with the relevant German (PEI), European (EMA), and US authorities (FDA) is essential.

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.

to the study centers – Germany >>

to the study centers – Worldwide >>

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