In summary, ALSUntangled strongly recommends that patients with ALS avoid the Stowe/Morales ALS Protocol. The rationale for this exorbitantly expensive protocol is unsound. The specific treatments being used range from mysterious, to already disproven, to potentially harmful. No valid outcome measures are being followed and the discussion of safety and efficacy taking place between sellers and potential patients considering this is impossibly optimistic.
Patient trials
The XCell-Center
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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The Hickey Wellness Center
The Hickey Wellness Center infrastructure is clean and professional. Dr. Hickey has a good bedside manner, and clearly believes in his protocol (indeed he himself is on it, and has had his own fillings removed). However, at this time, we are not convinced of a link between heavy metal toxicity and ALS. The metal testing performed in the Center is un-interpretable given the lack of ‘normal’ post- chelation metal ranges. Similarly, concerning are the lack of validated diagnoses, an appropriately detailed informed consent form, a consistent protocol across patients, objective outcome measures, or even adverse event tracking. As a result of these problems, ALSUntangled cannot currently condone most of the Hickey Wellness Center’s approach toward ALS. We do endorse two of Dr. Hickey’s practices: stressing hope, and once all the important information about an alternative therapy has been provided, respecting a patient’s wish to pursue it even if it is against our advice.