Patience is not my strongest virtue. Having to be patient, as a patient, while the Tisch MS Center finished fundraising and started building out the new lab to accommodate the study, has been excruciating.
The Subaru is long gone. The Cubs won the World Series! And we finally have a female President! I so wish I could really say that...
However, most notably in my world, we have changed my medication regimen in anticipation that Phase Two of the stem cell trial will actually, finally, truly, positively go forward! (For an explanation of Phase descriptors, click here: http://tischms.org/phases-clinical-trial)
Because the cells will be administered via a spinal tap every three months, it was decided to minimize the number of spinal taps I would be getting. Thus the medicine that was also administered via spinal tap is no more, and an IV drug is now being used to hopefully thwart continued progression.
Changing meds is a big deal, however, I still have more waiting to do. Appointment dates have yet to be assigned for my first date with the cells. Argh.
How do I keep waiting patiently? Tequila. Gin Martinis. My new favorite, The Hugo. And puzzles. Tisch still has the only FDA approved stem cell therapy trial for PPMS patients in this country, and the new lab is almost done! (http://tischms.org/believe-build-begin-fund) So I need to keep being patient.
The tunnel is still long, however at least there is now a pinhole of light at its end.
Tuesday, August 29, 2017
Update - July, 2015
Why I feel compelled to write only when confronted with an 'edge' point, is a bit of a mystery.
I write a fair amount each day, though have not had the urge to do so here in a while.
So what broke the camel's back this time? A combination of one part relief - that I am still considered to be part of Sadiq's study, even though the study has been delayed due to lab funding issues, and two parts supreme frustration with the Subaru car dealership's selling us a lemon and the mechanics putting this admission off as long as possible making me take the bloody thing in 5 times over the past 4 times, and FINALLY getting a phone call in saying they have to replace the brakes and take the engine out to be able to fix a leak in the cam case.
The reassurance from Sadiq's office is oddly not as gratifying than the victory over the mechanics proving that I was right about there being something wrong with the POS car for FOUR months, though obviously much more important.
Yet, I still have no new information as to when my second treatment will happen.
ARGH!
I heard of a story of a participant who had yet to receive any doses and was told that they would not be receiving any due to the funding crisis. To have hope given and then taken away is a situation into which no person with an illness would willingly enter. And this is why the fear of the study not proceeding was very real, and still will be until the second dose goes in.
Thus the satisfaction that the bloody car will be in the shop for at least a few days being taken apart and put back together at Subaru's expense and not mine. Needless to say, this will be the first and last Subaru in my life.
I write a fair amount each day, though have not had the urge to do so here in a while.
So what broke the camel's back this time? A combination of one part relief - that I am still considered to be part of Sadiq's study, even though the study has been delayed due to lab funding issues, and two parts supreme frustration with the Subaru car dealership's selling us a lemon and the mechanics putting this admission off as long as possible making me take the bloody thing in 5 times over the past 4 times, and FINALLY getting a phone call in saying they have to replace the brakes and take the engine out to be able to fix a leak in the cam case.
The reassurance from Sadiq's office is oddly not as gratifying than the victory over the mechanics proving that I was right about there being something wrong with the POS car for FOUR months, though obviously much more important.
Yet, I still have no new information as to when my second treatment will happen.
ARGH!
I heard of a story of a participant who had yet to receive any doses and was told that they would not be receiving any due to the funding crisis. To have hope given and then taken away is a situation into which no person with an illness would willingly enter. And this is why the fear of the study not proceeding was very real, and still will be until the second dose goes in.
Thus the satisfaction that the bloody car will be in the shop for at least a few days being taken apart and put back together at Subaru's expense and not mine. Needless to say, this will be the first and last Subaru in my life.
Tuesday, January 27, 2015
And the Countdown Begins…
Doctor’s schedule confirmed. The cells that were harvested have multiplied. Pete's consent obtained to be left alone with a six year old for a week. Parents have been informed that they are going to have a visitor. My peeps are on 'boo boo buddy' alert. Plane tickets have been purchased.
Let’s get this trial underway!
It will be nice not to wait and worry as much. It will be nice to be able to free up brain space to think of something else. It will be nice to be back in NYC more regularly for awhile.
As a refresher, I have agreed to be a participant in an FDA approved trial that will be looking at the efficacy of using autologous mesenchymal stem cells to stop the progression, and hopefully improve symptoms, in those of us with Primary Progressive Multiple Sclerosis.
Autologous means "(of cells or tissues) obtained from the same individual," and mesenchymal stem cells are cells that can differentiate into a variety of cell types - including nervous tissue. So the working theory here is that by inserting a high concentration of ones own cells that can transform themselves into anything, the body will start healing itself of any damage.
It is not a transplant. It is not surgery. No chemo. No anesthetic. Just my own cells. LOTS of them.
Dr. Sadiq's trial is different than the other two FDA approved trials in the US in that he is injecting a dose of 9-10,000,000 cells directly into the cerebral spinal fluid.
The week of March 23rd will be spent mostly at Sadiq's MS Center (http://www.tischms.org) being poked, prodded, and MRIed to document the 'before' state. Thursday March 26 will be the big day when the spinal tap and cell injection happens. Then home to be on my back for 24 hours so I do not get a spinal headache. Then Mom will fly back to Seattle with me on the 29th.
Let’s get this trial underway!
It will be nice not to wait and worry as much. It will be nice to be able to free up brain space to think of something else. It will be nice to be back in NYC more regularly for awhile.
As a refresher, I have agreed to be a participant in an FDA approved trial that will be looking at the efficacy of using autologous mesenchymal stem cells to stop the progression, and hopefully improve symptoms, in those of us with Primary Progressive Multiple Sclerosis.
Autologous means "(of cells or tissues) obtained from the same individual," and mesenchymal stem cells are cells that can differentiate into a variety of cell types - including nervous tissue. So the working theory here is that by inserting a high concentration of ones own cells that can transform themselves into anything, the body will start healing itself of any damage.
It is not a transplant. It is not surgery. No chemo. No anesthetic. Just my own cells. LOTS of them.
Dr. Sadiq's trial is different than the other two FDA approved trials in the US in that he is injecting a dose of 9-10,000,000 cells directly into the cerebral spinal fluid.
The week of March 23rd will be spent mostly at Sadiq's MS Center (http://www.tischms.org) being poked, prodded, and MRIed to document the 'before' state. Thursday March 26 will be the big day when the spinal tap and cell injection happens. Then home to be on my back for 24 hours so I do not get a spinal headache. Then Mom will fly back to Seattle with me on the 29th.
Then we wait some more.
That's it. Sounds easy, right? Oy…..
I expect I will need to sign some sort of gag order where I will not be able to write about any potential changes in my overall condition - either positive or negative. I will be able to answer friend's questions - so there will be added incentive to have those long awaited catch up conversations! That being said, others in the trial who have already begun treatment are mentioning some things which keep me hopeful and optimistic about the potential upside for me. (http://richardmcohen.com/hope-redux/)
However, I know all too well that each of us afflicted has a unique set of symptoms and reactions to treatment, so I am concentrating on preparing myself the best way I know how for this: exercising; eating as 'clean' as possible (no gluten, dairy or sugar - thank god Charlie's birthday is done with!); and understanding that this will not necessarily be a sprint - this is a Head race. In a single. With a headwind. If I am well prepared, conditions will not phase me and I just keep pulling as hard as I can to cross that finish line. With some Italian red wine to help in case of emergency.
However, I know all too well that each of us afflicted has a unique set of symptoms and reactions to treatment, so I am concentrating on preparing myself the best way I know how for this: exercising; eating as 'clean' as possible (no gluten, dairy or sugar - thank god Charlie's birthday is done with!); and understanding that this will not necessarily be a sprint - this is a Head race. In a single. With a headwind. If I am well prepared, conditions will not phase me and I just keep pulling as hard as I can to cross that finish line. With some Italian red wine to help in case of emergency.
Please do not be alarmed if you do not get any written updates, or see any reports of stem cell therapy scams. I have a lot of faith in Sadiq and his science. This trial is not a scam. He and his work are legitimate and potentially hold an important key to helping those of us with MS.
Here is to wishing for a steady tailwind!
See you in NYC.
Here is to wishing for a steady tailwind!
See you in NYC.
Tuesday, July 22, 2014
Still Waiting…..
…pretty patiently I might say.
As the end of the second month passes since my stem cell harvest happened in NYC, I am feeling pretty good. And no I have not called to bug the office asking when my first treatment will happen!
Can you believe it? I can't. But it makes sense to be patient on this one. So I am.
Not being so patient with regards to some other things, but for this particular item, I am.
I have found out that the last technical hurdle lobbed up by the FDA has been cleared, so the trial can proceed as planned. Which means that at least one other person will receive their cells this month and another next. And that is the end of the information I know.
My guess is that Tisch MS Center is being hush hush as they do not want to have any information leak out before they are ready to reveal results in a year or so. I bet once participants get treated, they sign a gag order. The one person I 'know' who has already received his cells - the journalist Richard Cohen - has not really said a word on his blog about his condition since his cells were re-injected this past Spring.
Hopefully though, this trial will be like reality shows where what happens gets revealed prior to broadcast. If only Reality Steve had an 'in' with Dr. Sadiq or Richard Cohen and could publish some spoilers every once in a while.
In the mean time, I get to obsess over other things (such as reading The Goldfinch in four days or getting nervous about C starting Kindergarten) and play 'hector projector,' thinking of all sorts of crazy scenarios that might emerge over the coming months. I also get to be diligent about keeping as fit as possible, and as healthy as possible.
So far so good.
As the end of the second month passes since my stem cell harvest happened in NYC, I am feeling pretty good. And no I have not called to bug the office asking when my first treatment will happen!
Can you believe it? I can't. But it makes sense to be patient on this one. So I am.
Not being so patient with regards to some other things, but for this particular item, I am.
I have found out that the last technical hurdle lobbed up by the FDA has been cleared, so the trial can proceed as planned. Which means that at least one other person will receive their cells this month and another next. And that is the end of the information I know.
My guess is that Tisch MS Center is being hush hush as they do not want to have any information leak out before they are ready to reveal results in a year or so. I bet once participants get treated, they sign a gag order. The one person I 'know' who has already received his cells - the journalist Richard Cohen - has not really said a word on his blog about his condition since his cells were re-injected this past Spring.
Hopefully though, this trial will be like reality shows where what happens gets revealed prior to broadcast. If only Reality Steve had an 'in' with Dr. Sadiq or Richard Cohen and could publish some spoilers every once in a while.
In the mean time, I get to obsess over other things (such as reading The Goldfinch in four days or getting nervous about C starting Kindergarten) and play 'hector projector,' thinking of all sorts of crazy scenarios that might emerge over the coming months. I also get to be diligent about keeping as fit as possible, and as healthy as possible.
So far so good.
Friday, June 13, 2014
Serendipity
The key project designer/architect of Seattle's Central Library was in town last month talking about what went into the design of the now iconic structure. The usual suspects of addressing needs of all constituents, usefulness, budget, purpose, etc all came up..but then in answer to a question essentially asking what about the purpose of the actual book is in the 21st century, Josh brought up 'the need to ensure serendipity' in finding a book.
Serendipity. It is a great word and concept and though I have not used it in awhile, I think it is time to use it again.
It is true that so much about the experience in a library - at least when I go with my son - is about browsing through the shelves to see what we can discover. To see which covers will captivate his imagination and which words he will acknowledge now knowing how to read. To see what will pass the test to make it to the check out pile. We can even manipulate the serendipitous-ness a bit by looking in the online catalog to discover ALL of the holdings on a certain topic. And then place holds on the ones that pass the title test.
Serendipity is also very much at work in the real world as to why things happen or why certain people contract conditions. Of course environmental conditions are not all serendipitous. If you smoke a couple packs of cigarettes a day, you will most likely get lung cancer. Your choice, your probable outcome.
At this point in the MS world, cause and effect is pretty much defined by serendipity. If you live above or below certain longitude lines, and don't get to sunnier climates enough, you have a greater chance of developing MS. If you then experience a major physical trauma, your chances increase. Bottom line is that they just do not know for sure why MS starts revealing itself in its targets.
The serendipity of how aggressive and progressive my MS path has been is maddening. Heart stopping at times. Ultimately the only things that will make the anger go away is by controlling the few things that I can: diet (I am gluten and dairy free and 95% fully plant based), body work and exercise. Thankfully a background in team sports has led to being pretty disciplined in these areas. Though every once in awhile, a margarita is the perfect medicine!
Pushing to be part of Sadiq's Phase 1 stem trial is most likely part of this control thing I got going on. Drugs do not do well in my body. Each one I have tried has made my symptoms worse. Double blind, placebo trials may be good to placate the FDA, but those are not the trials that will help me. Sorry drug companies. You had your chance and you blew it. So step away from the chalupa!
It is the trial guaranteeing a treatment with the fewest side effects and minimal time away from home that will help me AND help the medical research field. For the mom to a 5.5 year old and wife to an active, outdoorsy guy, that is music to my ears. I know the treatment may not work, but there are a lot of other trials going on out there involving stem cells, and there are heartening outcomes! I am hoping that serendipity has gotten its wiggles out enough already in my life and that the other positives outcomes around the world portend well for me and how the addition of extra stem cells cells will improve my symptoms.
The down side to being a participant in the trial is all the waiting……I am really not good at that.
Serendipity. It is a great word and concept and though I have not used it in awhile, I think it is time to use it again.
It is true that so much about the experience in a library - at least when I go with my son - is about browsing through the shelves to see what we can discover. To see which covers will captivate his imagination and which words he will acknowledge now knowing how to read. To see what will pass the test to make it to the check out pile. We can even manipulate the serendipitous-ness a bit by looking in the online catalog to discover ALL of the holdings on a certain topic. And then place holds on the ones that pass the title test.
Serendipity is also very much at work in the real world as to why things happen or why certain people contract conditions. Of course environmental conditions are not all serendipitous. If you smoke a couple packs of cigarettes a day, you will most likely get lung cancer. Your choice, your probable outcome.
At this point in the MS world, cause and effect is pretty much defined by serendipity. If you live above or below certain longitude lines, and don't get to sunnier climates enough, you have a greater chance of developing MS. If you then experience a major physical trauma, your chances increase. Bottom line is that they just do not know for sure why MS starts revealing itself in its targets.
The serendipity of how aggressive and progressive my MS path has been is maddening. Heart stopping at times. Ultimately the only things that will make the anger go away is by controlling the few things that I can: diet (I am gluten and dairy free and 95% fully plant based), body work and exercise. Thankfully a background in team sports has led to being pretty disciplined in these areas. Though every once in awhile, a margarita is the perfect medicine!
Pushing to be part of Sadiq's Phase 1 stem trial is most likely part of this control thing I got going on. Drugs do not do well in my body. Each one I have tried has made my symptoms worse. Double blind, placebo trials may be good to placate the FDA, but those are not the trials that will help me. Sorry drug companies. You had your chance and you blew it. So step away from the chalupa!
It is the trial guaranteeing a treatment with the fewest side effects and minimal time away from home that will help me AND help the medical research field. For the mom to a 5.5 year old and wife to an active, outdoorsy guy, that is music to my ears. I know the treatment may not work, but there are a lot of other trials going on out there involving stem cells, and there are heartening outcomes! I am hoping that serendipity has gotten its wiggles out enough already in my life and that the other positives outcomes around the world portend well for me and how the addition of extra stem cells cells will improve my symptoms.
The down side to being a participant in the trial is all the waiting……I am really not good at that.
Thursday, June 5, 2014
The Wait - Part 1
So the marrow has been harvested. Now what?
We wait. Again. For an unknown amount of time. Could be three months. Could be six months. Could be longer. We wait for a phone call from 'the scheduler.' Or perhaps the call might even come from my neurologist himself.
We are waiting for two things: final FDA approval for the trial to proceed and 10,000,000 mesenchymal stem cells to have been produced from my harvested marrow, providing enough cells for re-injection. Oh and I then have to wait for my turn in line.
Finding out about the additional FDA hurdle was a bit of a surprise. I thought that the approval had no strings attached. I should have known better. The FDA is the FDA and inherently has many other interests and concerns. But it is what it is, and I am confident that Dr. Sadiq and his team will address any outstanding questions as expeditiously as possible. They have come this far - they are not going to be stopped now.
10,000,000 mesenchymal stem cells. 10,000,000 sounds like a big number. In many cases it is - dollars, people, years, and in some cases, a large number, but not overwhelming. Considering how many cells are in the human body, and how many different types of cells there are, [ see this Smithsonian article for further context], 10,000,000 mesenchymal stem cells doesn't seem like a lot.
Assuming the FDA is satisfied with how trial patient #1 is doing after receiving his cells, I will be summoned back to NYC for the first 'dose' of 10,000,000 of my own mesenchymal stem cells. They will be given back intrathecally - meaning via a spinal tap so that these cells can be inserted directly into my spinal fluid. And then we wait some more to see what happens.
The ultimate goal - and what Dr. Sadiq is trying to prove - is that autologous stem cells inserted into one's spinal fluid - can fix damage brought on by MS.
There are plenty of others in the same shoes. By our calculations, there will be around 200 people with PPMS who have had their marrow harvested by Dr. Sara; whose cells have been grown under the watchful eyes of Dr. Harris; and in whose successful treatment Dr. Sadiq is so heavily invested. It is humbling to be part of this trial.
And so this phase of waiting begins.
#########
Here is a link to Dr. Sadiq and his Tisch MS Research Center of NY.
For those who want a bit more explanation as to what was entailed in the aspiration, what has happened to my marrow sample, and where the cells are being incubated, watch these videos made by trial patient #1, Richard Cohen and his wife, tv personality, Meredith Vieira:
Cell harvest: http://richardmcohen.com/the-great-stem-cell-caper-2/
We wait. Again. For an unknown amount of time. Could be three months. Could be six months. Could be longer. We wait for a phone call from 'the scheduler.' Or perhaps the call might even come from my neurologist himself.
We are waiting for two things: final FDA approval for the trial to proceed and 10,000,000 mesenchymal stem cells to have been produced from my harvested marrow, providing enough cells for re-injection. Oh and I then have to wait for my turn in line.
Finding out about the additional FDA hurdle was a bit of a surprise. I thought that the approval had no strings attached. I should have known better. The FDA is the FDA and inherently has many other interests and concerns. But it is what it is, and I am confident that Dr. Sadiq and his team will address any outstanding questions as expeditiously as possible. They have come this far - they are not going to be stopped now.
10,000,000 mesenchymal stem cells. 10,000,000 sounds like a big number. In many cases it is - dollars, people, years, and in some cases, a large number, but not overwhelming. Considering how many cells are in the human body, and how many different types of cells there are, [ see this Smithsonian article for further context], 10,000,000 mesenchymal stem cells doesn't seem like a lot.
Assuming the FDA is satisfied with how trial patient #1 is doing after receiving his cells, I will be summoned back to NYC for the first 'dose' of 10,000,000 of my own mesenchymal stem cells. They will be given back intrathecally - meaning via a spinal tap so that these cells can be inserted directly into my spinal fluid. And then we wait some more to see what happens.
The ultimate goal - and what Dr. Sadiq is trying to prove - is that autologous stem cells inserted into one's spinal fluid - can fix damage brought on by MS.
There are plenty of others in the same shoes. By our calculations, there will be around 200 people with PPMS who have had their marrow harvested by Dr. Sara; whose cells have been grown under the watchful eyes of Dr. Harris; and in whose successful treatment Dr. Sadiq is so heavily invested. It is humbling to be part of this trial.
And so this phase of waiting begins.
#########
Here is a link to Dr. Sadiq and his Tisch MS Research Center of NY.
For those who want a bit more explanation as to what was entailed in the aspiration, what has happened to my marrow sample, and where the cells are being incubated, watch these videos made by trial patient #1, Richard Cohen and his wife, tv personality, Meredith Vieira:
Cell harvest: http://richardmcohen.com/the-great-stem-cell-caper-2/
Cell incubation: http://richardmcohen.com/the-great-stem-cell-caper-part-two/
Cell re-insertion: http://richardmcohen.com/beginnings/
Aspiration
There are lots of questions to ask and perhaps the first might be about the significance of 10,000,000. Before I go there, I need to explain a couple of other things. For instance, what am I talking about and why? That might be a good start. But I don't really want to go there. I kind of just want to just jump in. And elaborate along the way.
Feel free to ask questions.
My goal is to be as clear and as factual about the stem cell therapy trial in which I am about to be a participant, and the effects of this therapy. Not to go into too much history. That might be boring. I don't need to go through a lot of it again, so why should a reader? We will see where it all goes.
Back to the title of this post - Aspiration.
After months (really over two years) of waiting, on Friday May 30, I had approximately 20 ccs of bone marrow aspirated from my sternum. In basic descriptive terms, a hematologist/oncologist inserted a corkscrew-like tool into my chest, about 6" below the adam's apple, and sucked out the marrow.
After seeing a video of another trial participant's procedure and hearing the doctors explain what would happen, I expected a more painful, longer procedure. The reality was that the most uncomfortable part was the prick of the needle placing anesthetic in the area, and that the time lapsed from walking into the office to walking out of the office was 45,' tops. No pain and efficiency. Gotta love working with Doctors who know what they are doing in their own clinics, and not with residents in hospitals. I hate hospitals.
Almost one week later, there is a tiny scab and a wee bit of bruising that remains at the site. Initial soreness, achey-ness that I compared to a massive bee sting on my chest was gone after three days. No side effects other than those resulting from traveling back and forth to the east coast, not exercising regularly for two weeks, and discomfort from the aforementioned ruptured ear drum.
I also have a mark on my arm from the site where they drew 40 vials of blood the day prior to aspiration.
That's it.
Seriously.
The only thing I did differently before and after the procedure was to eat bone broths the week before and days after to give my normally vegan diet an extra nutrient boost. And drink coconut water to rehydrate and have shooters of aloe vera juice to nourish the stem cells.
Honestly, the worst part of all this was the emotional trudging experienced while waiting for the day of aspiration. And more slogging is to come while waiting for the next steps to happen. Yippee. As most of you already know, I am not a very patient person. So all this waiting is BRUTAL.
Good thing I have some pretty darn cute, loving boys to support me on a daily basis, and some awesome friends and family members riding shot gun when they can. I am extremely thankful for that.
Feel free to ask questions.
My goal is to be as clear and as factual about the stem cell therapy trial in which I am about to be a participant, and the effects of this therapy. Not to go into too much history. That might be boring. I don't need to go through a lot of it again, so why should a reader? We will see where it all goes.
Back to the title of this post - Aspiration.
After months (really over two years) of waiting, on Friday May 30, I had approximately 20 ccs of bone marrow aspirated from my sternum. In basic descriptive terms, a hematologist/oncologist inserted a corkscrew-like tool into my chest, about 6" below the adam's apple, and sucked out the marrow.
After seeing a video of another trial participant's procedure and hearing the doctors explain what would happen, I expected a more painful, longer procedure. The reality was that the most uncomfortable part was the prick of the needle placing anesthetic in the area, and that the time lapsed from walking into the office to walking out of the office was 45,' tops. No pain and efficiency. Gotta love working with Doctors who know what they are doing in their own clinics, and not with residents in hospitals. I hate hospitals.
Almost one week later, there is a tiny scab and a wee bit of bruising that remains at the site. Initial soreness, achey-ness that I compared to a massive bee sting on my chest was gone after three days. No side effects other than those resulting from traveling back and forth to the east coast, not exercising regularly for two weeks, and discomfort from the aforementioned ruptured ear drum.
I also have a mark on my arm from the site where they drew 40 vials of blood the day prior to aspiration.
That's it.
Seriously.
The only thing I did differently before and after the procedure was to eat bone broths the week before and days after to give my normally vegan diet an extra nutrient boost. And drink coconut water to rehydrate and have shooters of aloe vera juice to nourish the stem cells.
Honestly, the worst part of all this was the emotional trudging experienced while waiting for the day of aspiration. And more slogging is to come while waiting for the next steps to happen. Yippee. As most of you already know, I am not a very patient person. So all this waiting is BRUTAL.
Good thing I have some pretty darn cute, loving boys to support me on a daily basis, and some awesome friends and family members riding shot gun when they can. I am extremely thankful for that.
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