Research provides a starting platform for safe clinical-grade human embryonic stem cell lines

Written by Elena Conroy

Researchers from the MRC Centre for Regenerative Medicine in Edinburgh (UK) analyzed the karyotype of 25 clinical-grade human embryonic stem cell lines that could be safely used in clinical trials for various conditions.

Scientists at the University of Edinburgh (UK) have analyzed the molecular karyotype of 25 different embryonic stem cell lines that could be potentially used for clinical trials. The study paves the way for clinical trials of cell therapies to treat conditions such as Parkinson’s disease, spinal cord injury and multiple degenerative conditions. The research also sets out a cost-effective approach for monitoring the quality of stem cell-based products and newly emerging cell therapies.

Stem cells have the potential to become any of the varied cell types found in the body. Researchers have been investigating how they may be used to repair or replace damaged tissues in patients. However, because these cells continuously produce copies of themselves, there are concerns that they may acquire genetic abnormalities that could lead to cancer. It is therefore essential to know the genetic stability of the human embryonic stem cell lines before progressing and being able to utilize them in clinical trials.

The 25 tested cell lines were all ‘clinical grade’ and met the strict quality and safety requirements for cell lines allocated for use as therapies. To detect whether these lines were safe, the team at the Medical Research Council (MRC) Centre for Regenerative Medicine (CRM) analyzed each of the cell lines by means of molecular karyotyping, a highly sensitive technique able to detect genetic abnormalities.

More than half of the cell lines carried large but stable genetic differences; however, these were found to be naturally occurring in the human population. A small number of the cell lines acquired genetic aberrations when grown in the laboratory for too long, which highlights the need for continued genetic testing of emerging stem cell-based products to ensure they are suitable for use in patients.

More than three-quarters of the global clinical-grade embryonic stem cell lines have been established the UK. The stem cell lines analyzed in the study were established for clinical use by the Universities of Sheffield and Manchester, King’s College London and Roslin Cells (all UK), a company that specializes in the production of clinical-grade cells for use in therapies

“This is the largest study of therapeutically useful stem cells to date and shows that we are in a good place to push forward new cell therapies into clinical trials,” commented Tilo Kunath, Senior Research Fellow at the CRM, University of Edinburgh.

“Collating a library of stem cells that we understand and know are fit for use in patients is vitally important if these are to be routinely used in the clinic,” explained Dr Paul Colville-Nash, Programme Manager for Stem Cell, Developmental Biology and Regenerative Medicine at the MRC. “This work complements that of the UK Regenerative Medicine Platform that is seeking to address the key knowledge gaps needed to accelerate development, and ensure the safety and efficacy, of emerging stem cell therapies.”

Sources:; Canham MA, Van Deusen A, Brison DR et al. The molecular karyotype of 25 clinical-grade human embryonic stem cell lines. Sci. Rep. doi:10.1038/srep17258 (2015) (Epub ahead of print).