Guide and hands-on support for clinical studies in cell therapy
An online guide is now available that provides step-by-step guidance for clinical studies in cell therapy. The guide was formulated within the Cell Therapy program, run by the Innovation Center at Karolinska University Hospital.
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The guide is divided into three areas:
1. Considerations during development
This section contains information concerning:
- the classification of cell therapies
- various types of studies
- data required to proceed to clinical trials
- how various types of cell therapies are classified
- the type of data and preclinical tests needed to be granted a permit to start a clinical trial
- how cell therapy products are manufactured.
The guide also includes information on how to obtain scientific and regulatory advice from the authorities.
The guide is designed to help anyone working within cell therapy, describing the requirements in Sweden, the EU and the US for assessing cell therapies prior to clinical studies.
2. Clinical trials
This section provides information about the requirements stipulated in regulations and directives that must be met during the planning, implementation and completion of clinical trials in cell therapy. Much of the information in this section can be generally applied to all clinical trials.
3. Application for market authorization
This section contains information on the application process in both the EU and the US.
One of the projects within the program, "Clinical implementation model for cell therapy in the public health setting", also formulated an operational model to address what functions would be needed specifically at Karolinska University Hospital to support the development of new cell therapies.
Regulatory mapping and sharing knowledge
The projects have jointly held internal seminars in cell therapy in collaboration with the Swedish Medicinal Products Agency and others. Reports summarizing information from external seminars and meetings have been written to share knowledge and experiences. At least three different cell therapy projects at Karolinska University Hospital have received support and guidance from these projects and gained approval from the Medicinal Products Agency to advance to clinical trials.
The project "Action plans for regulations, laws and ethics" has maintained continual contact with both national and international pharmaceutical regulatory authorities governing cell therapy. Comments that the project submitted to an open consultation prior to the EMA update of Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (ATMP) were included in the summary report that the European Commission published following the consultation.
The collaboration with Vävnadsrådet (Swedish national council for organs, tissues, cells and blood) has generated a shared understanding of how various cell therapies should be classified.
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