Note: 6 weeks after Dave's first stem cell procedure - I decided to blog about our journey instead of the emails I had been composing to family and friends. So these first few entries are in order, but were not posted at the time events were happening.
Dave's first attack was in 1995. Following a bout of flu, his entire left side went tingly and he lost most of his strength in his left arm and leg. (yes, he's left-handed). The GP escalated our case until we got to a Neurologist. Thank goodness our initial team was MS savvy enough to get us there in a relatively short time. His MRI revealed plaques - one of which was right in his spinal column - the swelling of which was cutting off the nerves to that side. 5 days in the hospital with steroids reduced the swelling and he was good to go. Meanwhile, the plaques were consistent with MS, but again, at that time MS couldn't be diagnosed until you'd had "Multiple" attacks over time. We were told to go home and assume this was a one time deal stemming from an immunological over reaction to the flu.
Two years later, David had an attack that left him with such severe vertigo that just getting from the bed to the bathroom was nearly insurmountable. That GP told us -- "Oh, No this couldn't be neurological" ... so sent us to an ENT to check for ear infections. *sigh* At least the ENT was quick to get us referred back to the Neurologist. And voila - MS was diagnosed.
For about 12 years he was on series of interferon treatments, which worked very well to control the disease - no one could tell he had anything unless we told them.
Until about 2012. He started having more difficulty walking. He got slower, and fatigued quickly. Tripped easily. Unfortunately we were so attuned to ignoring the MS - we were very slow to react.
In the spring of 2013 we took an amazing trip to Costa Rica, where we road horses for 5 days from the mountains down to the coast. It was the first time he'd taken trekking poles with him - to use if he needed them. Didn't need them much, but it was clear things were progressing in a direction we were not happy about.
Over the summer, we visited a handful of notable neurologists in the area looking for one that was better suited to tackle MS than the one David had been with. We were quite pleased to select Dr. Tamara Miller who practices in Fort Collins. She put Dave on Tysabri - which to our delight was a once-a-month infusion rather than weekly, or multiple times weekly, injection.
Unfortunately, his MS has continued to progress. He has significant difficulties walking, and fatigue and bladder issues are a daily if not hourly struggle for him. His trekking poles are nearly always necessary. I guess there is still some fuzziness as to whether he has moved into a Secondary Progressive stage of MS or not (something I had thought we had declared in 2013 but in talking to Dr. Miller now she isn't willing to definitively state), but clearly he hasn't responded to either of his treatments in the past few years; treatments which are only effective for the Relapsing-Remitting form of MS. Something, for sure, changed a few years ago.
Of all people, our physical therapist, Dr. Caroline Creager, turned us on to a doctor in Loveland who is doing some very interesting things with stem cell treatments; specifically adipose tissue-derived mesenchymal stem cells (AD MSC's). Meaning they are collected and extracted from abdominal fat.
So HEY! Bonus points for the fact that this treatment means he gets to get some liposuction! (sadly, not enough to change his body image...)
This doctor, Dr. Pat Mallory, is a DO - Doctor of Osteopathic Medicine. His practice specializes in treating people with chronic join pain with stem cells, and he's had some remarkable success. Interestingly enough, we have a horse who is going through a very similar treatment now for a torn ligament in his hind leg.... because these treatments are always approved for animals long before humans.
Dr. Mallory also uses stem cells to treat other conditions - he's just not an expert on them. He has treated patients for COPD and ALS. Not MS, however.
Our physical therapist has a son with a very unusual spinal disorder. Dr. Mallory did his first "intrathecal" (very low in the spinal column - basically a spinal tap in reverse) injection a few months ago, and a few weeks ago did his second. He's been making a lot of improvement - his pain for the first time in years has been minimal to completely gone. In the week following his first injection he not only made it to school every day on time, but also opted to go hiking with his buddies - something that was out of the question just a week prior. I believe either the improvements fade, or they at least plateau, so they anticipate needing repeat treatments. Sadly this is quite difficult for them because.... their son doesn't have any more fat to harvest cells from!! This is at least one problem David doesn't need to plan for (nor I for that matter).
We've spoken a few times with the researcher in Florida who has pioneered this technique to extract MSCs from adipose tissue. According to her, the significant differentiator of their technique is that it produces a far greater number of viable stem cells - as opposed to techniques that extract stem cells from blood or bone marrow. She has used this technique on some MS patients - but less than 10. The results have been different per individual, as MS tends to be anyways. Ranging from little observable benefit to dramatic improvements.
So. Our physical therapist is in the process of getting a baseline status for Dave, physically right now. I expect she'll repeat the assessments monthly following treatment to track progress. His neurologist has taken a fresh set of before-MRIs, and will also be monitoring his progress. It's generally acknowledged that a disease like MS will require repeated treatments - which in itself is another whole ball of FDA wax - but we'll deal with that when we come to it.
And... you might wonder - doesn't me losing my job throw a wrinkle into the plan? Interestingly enough, not really since this treatment isn't currently approved by the FDA, and thus is not covered by insurance anyways. We will of course have Cobra to fall back on for ancillary stuff.
It's worth noting that we have investigated a number of clinical trials that are going on now using stem cells on MS. I admit that I did that research somewhat to appease Dr. Miller, since is has been her unwavering position that she can only recommend participating in a fully regulated clinical trial. Our observations are:
- none use this particular technique of extracting cells
few use an intrathecal injection - most are IV only. But to treat a central nervous system disease, even if some IV cells cross the blood brain barrier, it would be far fewer than injecting directly into the spinal column.
- because the FDA is so far behind in this technology - very few studies are focused on clinical improvement of the patients - but more focused on establishing that the treatment is safe. Europe is far ahead of the US in stem cell therapy and Dr. Mallory can attest that athletes have been traveling to Europe for treatment for many years - when he's only recently started to be able to offer it here.
- the studies we found looking for clinical improvement, are testing a protocol where the immune system is first destroyed with chemotherapy drugs and then stem cells are introduced to help rebuild the immune system. No thanks. (actually, recently we're seeing trials that are foregoing the kill the immune system step - we will cross our fingers they prove as successful.)
- the studies we found focused on clinical improvement are largely cross over studies - so that both 'groups' of subjects get the treatment, but you don't know whether you get it immediately or will start getting in 6 months. David's neurologist doesn't want him going more than 3 months without treatment, so it seems like a huge risk to enter into that lottery.
- all clinical trials would require travelling to one of their sites in the US or Europe - multiple times. And many require the subjects to pay for the treatment as well.
It is a reaction to Dr. Miller's position that I've named this series of blog posts "Beyond the Barriers", because it does feel like we are going off-road here, into uncharted territory. For the first time we are taking the lead in setting his path forward, simply because the other available options just don't seem to have much to offer us. But moreover, we are hoping that this treatment will not only help halt the MS progression, but also help David regain some of the functionality he's lost. To break through the barriers that the disease has been erecting around him.
So sticking with a local doctor, whom we know will be administering stem cells immediately and allowing our local neurologist and physical therapist to help monitor his progress - the choice, terrifying and difficult as it was, was simple.
Dave's procedure is scheduled for November 4th.
Labels: Beyond the Barriers