ALS Advocacy

ALS Advocacy
Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Sunday, September 8, 2019

Where's The Bar?

How high is it?

Or more important to us all,  how low is it?

The bar?  We're asking about the bar for being listed at clinicaltrials.gov.

Is it a high bar of standards for a trial that we should trust?

Or is it a low bar with some expensive, sloppy experiments interspersed with the important clinical trials moving through a serious FDA approval process?

Why are we asking so many questions about that bar?

Check this out --
https://www.clinicaltrials.gov/ct2/show/NCT02795052?term=02795052&rank=1

It's a stem cell therapy aimed at very broad set of neurological conditions.

The endpoints seem very loosey goosey.

The eligibility criteria seem very loosey goosey.

So we have lots of questions.  Especially after we went to the sponsor's website and found out that having $17,000 to pay to join this experiment seems to be an unspoken inclusion criterion.

https://www.mdstemcells.com/neurological-stem-cell-treatment-nest/

Is this something whose data are going to the FDA as part of an approval process, or has clinicaltrials.gov essentially advertised for yet another unproven stem cell purveyor?
Why is there no phase listed?
If you qualify for this "trial," do you have to pay $17,000?
Do the investigators have an ownership interest in the sponsor?
Are the investigators ophthalmologists and not neurologists?
Do the investigators have an ownership interest in the surgery center?
Does this "trial" have an EAP RTT policy listed anywhere?
Is this the ALS RTT "trial" offered by Garr and Beacon of Hope?
Is this the ALS RTT opportunity that Beacon of Hope expects 200-300 people with ALS to pay for?
If you somehow don't qualify for the $17,000 version of the "trial," will it cost $20,000 to go RTT via Beacon of Hope?
Is either the sponsor or Beacon of Hope a part of the upcoming symposium at the ALSA Florida Chapter (which is so convenient to the surgery center)?
And back to our original question, where's the bar for being listed at clinicaltrials.gov?

Do we have a lot of questions?

We do.

Insights and answers and public discussion are always appreciated.








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