Clinical Research

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.

 

General Information about Clinical Trials

As a research company in the field of stem cell based medicine it is the goal of RHEACELL GmbH & Co. KG to develop innovative therapeutic options. RHEACELL GmbH & Co. KG is a subsidiary of TICEBA GmbH, which produces as a drug manufacturer (§13 AMG) cells for the clinical study. An integral part of the research program of RHEACELL GmbH & Co. KG is the development of new therapeutic areas and the implementation of the data obtained in clinical trials for subsequent approval. The standards of the clinical trial subject to the medical and ethical standards and are multicentric carried out to achieve a comprehensive patient population at German Hospitals by medical experts. Besides European countries, studies are currently prepared and planned in the United States. Interaction with German (PEI), European (EMA) and American authorities (FDA) is essential.

Each clinical trial is approved by the relevant national authorities and ethics committees. Within the studies the investigational products are examined on their safety and efficacy in a specific group of patients. All studies meet the ethical principles of the Declaration of Helsinki of the World Medical Association and the Guidelines for Good Clinical Practice (GCP, Good Clinical Practice) of the International Conference of Harmonization (ICH).

 

Registration of Clinical Trials

The RHEACELL GmbH & Co. KG clinical trial study design can be found in a public clinical trial registry at www.clinicaltrials.gov and www.clinicaltrialsregister.eu. The information is registered with approval of the final study protocol prior to the start of the study and before obtaining the informed consent of the first patient to participate. A regular review of the information shall ensure its timeliness.

 

Current Clinical Trials

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License

Besides the authorization to manufacture a human medicinal product in accordance with § 13 (1) of the German Medicinal Products Act (AMG) for autologous mesenchymal stem cells, TICEBA is also authorized to manufacture a medicinal product for allogeneic mesenchymal as well as allogeneic limbal ABCB5 + stem cells following a recent extension. For more information click HERE.

Clinical Trial

Together with our subsidiary RHEACELL we are recruiting patients with the indication chronic venous ulcer (CVU) for the clinical trial in phase 1/2a. For more information click HERE.

The Story of Stem Cells

Review our category "The Story of Stem Cells" with the newest topic "Stem cells in wound healing" HERE.

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