While we applaud the use of informed consent for portions of the XCell-Center protocol, and the presentation of pilot efﬁcacy and safety data, in our opinion many worrisome questions and problems remain. From a rational standpoint, we feel it is unlikely that all the diverse diseases (some without a name at all) being treated at the XCell-Center would respond to the same type of treatment. Nothing useful can be concluded from the ﬂawed ALS pilot data that are presented; the positive effects reported are very likely nothing more than a placebo effect as seen in the ﬁrst of our patients above. Regardless of whether the XCell product results in new motor neurons or promotes sprouting of existing ones, patients with ALS would not be expected to have improved motor function just one or even a few months after treatment as is being claimed. In our opinion, these misleading pilot data should be removed from the website or at least qualiﬁed with appropriate disclaimers.
We hope the XCell group will present all their ALS data for peer review, including evidence that their cells are surviving, as well as objective clinical outcome measures over a reasonable length of follow-up. This would be a useful ﬁrst step toward planning what is ultimately necessary to demonstrate the safety and efﬁcacy of this protocol – a randomized, blinded, controlled trial. Until this is completed, we do not condone the XCell Center’s protocol for patients with ALS.
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