The NP001 formulation of sodium chlorite acts through a plausible mechanism and preliminary data suggest that it is safe and may slow ALS progression in some PALS. The WF10 formulation of SC appears to act through this same mechanism. Although WF10 is available for off-label use, it is very expensive, may have more side-effects than NP001, and at this time has only scant anecdotal evidence for efficacy in PALS. ALSUntangled supports further carefully monitored studies of NP001 and WF10 in PALS. In contrast, oral sodium chlorite has potentially dangerous and toxic side-effects may hasten disease progression, and is not clearly absorbed from the gut. We do not recommend further use of oral sodium chlorite unless it can at least be shown to be safe and to act on mechanisms in humans that are relevant to ALS.
Risks (harms that occurred on this treatment)
We applaud the openness of this clinic in publishing its preliminary results. However, at the present time, there are insufficient safety or efficacy data to support stem cell transplants at the Hospital San Jose Tecnologico de Monterrey as a treatment option for ALS. Also, more rigorous studies are needed to clarify safety and efficacy concerns.
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The ALSUntangled program is off to a good start, with a number of specific requests from PALS being investigated by a multi-national group of ALSclinician-scientists. PALS and other clinician-scientists who want to become involved in ALSUntangledcan find instructions online (16)