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Cell Therapies Clinical Trial Best Practices

Goals

To find examples of best practices for designing and conducting cell therapy clinical trials.

Early Findings

Below is a list of papers and articles on designing and conducting cell therapy clinical trials:

1) Overcoming barriers to facilitate the regulation of multi-center regenerative medicine clinical trials

  • This research paper published in the Stem Cell Research Therapy journal in 2018 addresses the issue of patient recruitment for cell therapy clinical trials.
  • In the context of this type of treatment, research tends to focus on less common diseases, which makes the recruitment of a large number of participants challenging.
  • A proposed solution to solve this issue and raise the number of patients willing to participate in the trial is to conduct a multi-center clinical trial.
  • This research paper evaluates this option and provides recommendations on how to conduct this type of trial.

2) Designing the Future of Cell Therapies

  • This white paper published by the Parker Institute for Cancer Immunotherapy provides suggestions to further advance clinical research in cell therapy by implementing some new methods that have not been used in current trials.
  • These recommendations include conducting small and data-intensive clinical studies, in order to determine the most interesting approach to pursue.
  • This new approach would be beneficial to apply in order to optimize the selection of patients for the trials.

3) Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products : Guidance for Industry

4) Unique Aspects of the Design of Phase I/II Clinical Trials of Stem Cell Therapy

  • This open-access peer-reviewed chapter is from a 2017 book called "The Management of Clinical Trials".
  • It describes some of the unique aspects linked to conducting clinical trials of cell therapy compared to other types of clinical trials.
  • These recommendations are destined to assist investigators in designing cell therapy trials.
  • They include advice on the choice of an optimal dosage and delivery route, which constitutes a chellenging aspect of this type of trial, but also on the type of manufacturing facility for stem cells, and the need to develop new surrogate markers.

In addition to this public search, we scanned our proprietary research database of over 1 million sources and were unable to find any specific research reports that address your goals.

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