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.

TICEBA also possesses the license within the meaning of §20b (1 and 2), §20c, and §72b of the AMG for the authorization for the extraction of tissue, the treatment or processing, preservation, testing, storage, import of tissue or tissue preparations.

All described activities are carried out by TICEBA in accordance with the authoritative European and German instructions in compliance with Good Manufacturing Practice (GMP).

Under these strict conditions, your cells from the skin and the stem cells contained therein can be used in the case of need as raw material for the manufacturing of an autologous (from the patient himself) or allogeneic (from a donor) medicine.

News
Coronavirus and Mesenchymal Stem Cells

Therapy for Pneumonia Patients infected by 2019 Novel Coronavirus

Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19)

Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With 2019 Novel Coronavirus

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).

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