February 5, 2019

From the standpoint of a patient, I have been observing from the sidelines an intense and baffling hubris that has arisen among too many clinicians, scientists, and other innovators in the stem cell world. It seems to stem from an over-confidence in one’s own subject m...

October 17, 2018

Two years ago, a list of stem cell clinics, (along with their associated practitioners) offering “unproven”, “unapproved” cell-based therapies was published, provoking a broad and enduring drumbeat of concern and controversy and spawning countless cautionary articles,...

March 20, 2018

Since my somewhat back-ended entry into the regenerative medicine spotlight almost three years ago, I’ve felt a bit like a 55-year-old poster child for what I soon realized was an inconvenient truth: there are patients in the U.S. receiving significant benefit from not...

November 9, 2017

I remember having a worrisome conversation with a patient and friend of mine around the time that the agenda and speaker list for an FDA Public Hearing on Draft Guidance for HCTPs were reaching final form. It was difficult to see my friend palpably afraid that the ther...

September 26, 2017

Recently, I taught a module on regulatory trends and RMAT strategy at a hands-on weekend clinical training event in Austin, one of those events at which clinicians planning to integrate cell-based therapy within their current practices learn the basic theory, principle...

August 3, 2017

I’m very positive about the future role of the FDA in ensuring that stem cell and related therapies are safe and effective.

And, because of that, I believe now is the appointed time for both patients and therapy providers to be intentional in helping to rewire their own...

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