Now six years into its existence, the induced pluripotent stem (iPS) cell field is no longer in its infancy to put it mildly but what will it take to get IPS cells to patients?
Perhaps one might say that cutting edge new scientific fields advance in dog years.
In that way of thinking, the iPS cell field is really middle aged (42 years old).
Yet are iPS cells any closer to being used in actual patients to realize the dream of patient specific therapies?
I think the answer is “yes”, but even so we have a long way to go.
In a new review article, Key anticipated regulatory issues for clinical use of human induced pluripotent stem cells, in the journal Regenerative Medicine, I discuss some of the key issues from my perspective. I’m not citing my own paper for shameless self-promotion, but rather because I worked hard there to articulate the critical issues and I think you might find it an interesting and useful resource.
I wrote it after lengthy discussions with many experts in the field and the FDA, although they preferred not to be quoted.
The key issues in my mind for clinical use of iPS cells include the lessons from the regulatory pathways of human ES cells that established a ground work, potential unique issues for iPS cells such as genetic modification, possible future requirements for genomic QC, and concerns about iPS cell stability in bulk culture.
Despite these challenges, I’m optimistic that iPS cells can “jump the dish”, as I said in a previous review, to help patients in the future, perhaps in 10 years. Cost and timing are additional important issues that may make batch-prepared ES cell-based therapies more appropriate for certain ailments. I can’t wait to see what the future brings in this exciting, not quite so new field.