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.
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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/
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