Following on HP's comments on the results (not comparison), I thought I'd determine the ALSFRS-R scores: closest to stem cell injection and most recent, and rate of change per month post-op. The results:

5 injections, 12 month change in ALSFRS-R:
4 to 3, -1, -0.1/mo
8 to 3, -5, -0.4/mo
14 to 8, -6, -0.5/mo
34 to 24, -8, -0.7/mo
32 to 16, -16, -1.3/mo
32 to deceased

10 injections, change in ALSFRS-R:
27 to 44 in 3 months, +17, +5.7/mo.
29 to 29 in 6 months, no change, 0/mo
34 to 34 in 3 months, no change, 0/mo
37 to 31 in 9 months, -6, -0.7/mo
33 to 25 in 6 months, -6, -1.0/mo
38 to deceased

With this information, I disagree with the thinking that 8 of 10 were stable post-op. The average progression rate is about -0.07/mo, so many of these values are very typical of natural progression. FightingALS' case is certainly exceptional. Perhaps one other is exciting as well, with no change in 6 months. Possibly the one with no change in 3 months (<0.25 points/mo), also.

To Ron's comments about "newbies" versus "oldies", I believe current condition is more relevant than disease duration. And, only 3 of the 12 were worse than FightingALS at the time of stem cell injections, based on ALSFRS-R. He also had what I would consider a fast progressing case (-1.2 points/mo. before SC), and was 1 of 6 at 3 years or less, and the "newest" by only about 1 month.

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per·se·vere [pur-suh-veer] - to persist in anything undertaken; maintain a purpose in spite of difficulty, obstacles, or discouragement; continue steadfastly.

fightingals wrote:



Interesting that the cells seem to have had a positive effect on your breathing when that is one thing they will try to accomplish with the cervical injection if they get the go ahead.

Jason

Throw out the low and the high in the ten injections and it looks pretty good. I don't count the 5 injection. That wasn't enough cells. That's apparent from the start

I agree, who knows the result with 2 or 3 mln of stem cells huh?

Perhaps the difference has to do with something related to this?

Cristina

i am inclined to agree with Ron on the people who received only 500k on one side. They were never going to see efficacy and skew any attempt to estimate efficacy.

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ENV
= Le meilleur vin, avec les meilleurs amis. =

I agree with separating the 5 injection and 10 injection groups. But, I am just pointing out that doing so also removes the ability to conclude any "late stage" efficacy, since the lowest FRS was 27. I don't agree with throwing out high and low, but if you do, you have a sample of 4 and a low initial FRS of 29. There are people in the NP001 trial with similar initial ALSFRS-R scores. This is not surprising when the last 6 Neuralstem patients had to have FVC >60% (NP001 was >70%), and these Neuralstem patients had to be ambulatory, while NP001 participants did not. And with a disease where the median survival is less than 3 years from onset, we don't need long survivors to get all stages of disease.

People with a rate of change of 0.7 points lost per month and 1.0 points per month certainly are progressing normally. And, even no change for 3 months is not rare. See HERE and HERE. Yet, these are 3 of the 4 that some think show almost no progression.

I have been in the NP001 trial for 17 weeks, 4 months. My ALSFRS-R is higher than when I began. So is HP's. So is dog423's. And, there are others with no change, or a 1 point loss in 4 months (<0.25 points lost per month). Now I am comparing NP001, but mostly to show that all but 2 of the Neuralstem histories are not amazing.

That people are careless or inconsistent with ALSFRS-R doesn't make it a bad questionnaire. I strongly suspect that the same rater did the scores for the Neuralstem study. And, if not, we don't see yo yo scores. ALSFRS-R requires patient answers, so I think PALS share in responsibility for inconsistent scores. I give the answers for every questionnaire I'm given, and discuss answers the rater challenges. I hope that all study participants do likewise, and take it seriously, as it is often the primary efficacy measure.

I am not trashing the Neuralstem trial, and consider fightingALS' experience due to the study. I am also encouraged by the one with 6 months with no change. But, I don't agree that 8 of 12 have almost no progression.

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per·se·vere [pur-suh-veer] - to persist in anything undertaken; maintain a purpose in spite of difficulty, obstacles, or discouragement; continue steadfastly.

You may not need long survivors , but we are here and need to be included in trials. You say that pretty easily, Pers. Kinda sets wrong wth me.
We get it. You are big on NP001. We would of been to , if they would of included some of us. But as you say... We wasn't needed .

Ron - I am sorry you are misinterpreting me. I probably chose bad words, so let me try again:

ALS is generally a very agressive disease, where most die less than 3 years from onset (not diagnosis). And, because of this, many people with disease durations even less than 2 years can perish, or qualify as late stage PALS. Living for years beyond the 90th percentile doesn't necessarily represent a worse condition than those less than median. I am not expressing an opinion on accepting longer duration patients into trials. After my current trial, I will be in the same boat.

And, again, my analysis of ALSFRS-R scores, beginning and later, had nothing to do with a comparison to NP001. I didn't say, or imply, that you weren't needed! In fact, I continue to comment that I feel trial inclusion/exclusion criteria need to be better. And, I don't just complain, but take action, and can claim success in leading to relaxing one trial's inclusion requirement already.

Again, I am excited about Neuralstem. If they'd accept me among the final 6 for phase I, I would happily volunteer.

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per·se·vere [pur-suh-veer] - to persist in anything undertaken; maintain a purpose in spite of difficulty, obstacles, or discouragement; continue steadfastly.

Pers. Sometimes you make my ass tired. I don't need a lesson in ALS 101 . You don't have to explain a thing about how it works. Im going into my ninth year.
Let is know when your action provides results.