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Tedstehr

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I emailed the coordinator at the SFO clinic and I am considering enrolling. I would have to stop Edaravone at least thirty days before my visit which could potentially affect my decline. We have cousins in San Fran who would most likely put us up for the nights we are there. But it is a lot to consider. Firstly, if I would qualify. I think my progression falls into their parameters but I am not certain. Then, I could get the placebo which means a lot of energy and effort that could itself shorten my life. But the opportunity cost of not trying it is massive too. By the time this drug is marketed, assuming a successful outcome, it could potentially be too late for me to have a decent quality of life. Lots to consider!
 

Par220

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I agree it is a tough situation to decide. I'm bothered by such a large placebo group for this trial. I'm not eligible to even consider this so all I can do is try to find anyone and everyone who has received it and has shared their experience. I would hope if any ALS trial has positive results they would try to make it available ASAP. Here are a few others I heard about.

Here is someone from the Phase 2 with dramatic (temporary) results after a single dose.

Https://www.change.org/p/brainstorm-pursue-accelerated-approval-of-nurown-treatment-for-als-patients

Here is someone else with dramatic (temporary) results from the Brainstorm Nurown Phase 2 with just a single dose.

Colorado Man Takes Personal Fight With ALS To State Capitol « CBS Denver

Here is someone in Phase 3 who says his hand strength increased 1 month after the 1st injection (of 3).

UCI researchers studying ways to slow the progression of ALS | abc7.com
.
 

jethro

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it is very usefull. thanks to all. does anybody have an idea should nurown be appliead whole life, every circle will lasts longer and longer (very possible)... or? have you idea how much it will cost?
 

KarenNWendyn

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Jethro, those are great questions and there are no answers yet.

I suspect repeated treatments would be needed indefinitely because it is not a cure. I suspect people in the study will experience some degree of relapse once the study ends, while waiting for the treatments to be officially approved.
 

jethro

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sure, that is logical answer, but we should have in mind that body is plastic. i.e. taking vitamins - when you take vitamins, your body is used to higher doses. in the begining, you pee all your money paid for vitamins, but after certain time, your body requires higher doses of vitamins. i think that it is the same with stem cells. mechanism of intake is different, but i think that prolongue apply/treatment can make some changes in membranes of neurons. at least, it can be every 28 weeks, 35 weeks, 45 weeks etc. price does matter. this is something completely different. it can not be taken orally like riluzole and wannabe oral radicava. there is one more thing noone count on: stem cells are incredible tool and effects (dont want to use term SIDE) are unknown. i think that full efficiency will emerge in a few years. not just positive effects, but side effects also. it is very dengerous game, but i dont care if it will emerge in 20-30 years :)
 

Tedstehr

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I am having second thoughts about volunteering for this trial. It is 14 visits to SFO which is a big chunk of change for me in airfare and hotels. Strangely, they will be charging for the first visit $600 +/- $200 with a 40% discount if you pay on that day. And I am not clear if this is before or after you are approved. The person I have been emailing could not say if placebo patients would get the drug for free after the trial. Also, the first trial reports six people who had increased FVC but not much else or what happened to the other 48 in the trial. And almost any information you can find out about Nurown from their site is investment opportunities. I wish they could clarify some of these issues because it could be several years before approval by the FDA and then who knows how much longer until Health Canada approves. Could be too late for a lot of us.
 

lgelb

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This page summarizes the results to date.

I have attached the key AAN abstract presented last month.

Looking at the protocol summary, the procedure and considering the market/regulatory landscape, as Karen said, I see no possibility that the placebo participants will be crossed over to treatment within the trial, and there is really no mechanism for fully funding treatment once the transplants are approved for marketing.
 

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jethro

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@tedstehr i also emailed spouse of one patient. patient walk out of chair and made few steps which he couldnt do before.
guess, is he placebo or not?
this is the FIRST injection. second one comes this week.
progress/plateau is not linear and it will tak a while while organism use to that shock.
all that amounts you have mention are peanuts compared to prices after nurown passes phase III.
anyway, you can gamble on nasdaq. I wish i bought shares when they were below 3 usd.
it is bullish share. if you dont believe to announcements and testemonials, believe share traders.
you can get cure for free and even save up serious amount of money.
target is 12-15 usd.
they have ms and autism in preclinical trial (pipline).
 

Tedstehr

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I just re-read Karen’s initial posting. I must’ve missed the part about no concessions to placebo patients. Thanks Laurie and Karen
 

jethro

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On March 21, 2018, the House of Representatives passed a right to try bill, sending it to the Senate for consideration. On May 22nd, the Senate passed the bill, now it is sent to the President's desk for his signature.
Really, I don't know real meaning of this, except that it applies to terminally ill patients to use FDA not (yet) approved drugs/treatments. I strongly believe in Nurown, and i want to pay to be treated. Are there any limitations in this? Does it applies just to US citizens? I'm from Europe... Please, share some info if you know. I don't have time for bureaucracy, just like all PALS. People dont have idea what is ALS except pals, caregivers and doctors.
 

lgelb

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The Right to Try bill is not going to change much. The FDA already approves most applications for compassionate use for treatments in early trials, and the bill only applies to patients not eligible for trials of the treatment, for whom the manufacturer agrees to supply it.

With NurOwn, a series of surgical procedures, as you can appreciate, the company developing the treatment will not be able to make it available outside the trials, so you are not going to see applicability from that legislation, I'm afraid.
 

jethro

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@igelb thanks for clarifying...
i do not meet criteria/i'm not eligible, i'm not us citizen and i am not fast progression. that is all. i sold my real estate and i have money. asked bstorm if there's posibility to apply nurown anywhere, i'll come and i'll pay. i don't expect to be compassionate patient. procedure/drug is here, patient is here, same as money, meets all criteria except us citizenship and fast progression.
can help me anybody with advice? what should i do with money? i sold real estate to try to heal myself. to buy a gun? jesus, what a pat position...
 

lgelb

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Jethro,

I understand [as much as a CALS can] your frustration. There's a lot of territory between NurOwn and a gun, that qualifies not as "healing yourself," but as "helping yourself live better." We've had several threads about the ways that people here extend the quality and quantity of their lives. These include:

Active-to-passive range of motion exercises
Massage to prevent/reduce edema
Respiratory support as soon as needed, with adequate secretion removal
Mobility devices to avoid falls, likely culminating in a power wheelchair with elevation, tilt, recline, power foot rests
A bed that allows for an optimal position to avoid pressure injuries and facilitate lift transfers
Maintaining body weight, through nutrition and hydration, via tube if/as needed for adequate intake
Judicious use of supplements (several threads)
Adequate sleep, social/nature/arts interaction, continuation of hobbies/pursuit of interests adaptively if possible

I could go on, but you get the idea. We do not know what the future holds in terms of treatments and availability, but maintaining your ability to benefit and maintaining your own best "standard of care" is a pretty no-lose strategy.

Best,
Laurie
 
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