Researching Stem cell therapies for degenerative disc disease or DDD.

So on my brother’s birthday I read an article that blew wide open the practical possibilities of treating my pain. First let me just elaborate on my medical condition.

At the start of 2011 I was suffering from severe and debilitating pain that started at my neck and ran down my right arm. I lost sensation in my thumb and index finger and had limited neck movement. I couldn’t look up or cock my head to the right. 2 weeks of physio did nothing, except that using the recommended pillow gave me some critical relief, and I went to see a orthopaedic surgeon in Cape Town. An MRI revealed I had herniated discs between C5 and C7. Spinal discs are the shock absorbers and hinges of the spine. However, they cause problems for large segments of the population, a throwback to the fact that humans are still learning to stand upright from an evolutionary perspective. I was told that if the pain was in the neck area, operating was not recommended and I was told to see how it recovers on it’s own.

dan_cervical_mri

My MRI. The grey vertical line next to the spine is the spinal chord. The white surrounding it is the spinal fluid. See how the two black discs push against the spinal chord. The green is radioactive material from my failed super hero operation ūüėČ …just arrows showing the herniations

And it did heal somewhat, but not completely. I have a constant dull pain and still limited sensation in the two fingers mentioned. If that were the state of play, I would be happy to live with it. However, as I found out when deciding to ride the Argus this year, I can’t spend more than 5 minutes on a bike without experiencing significant pain (that ended any ambition of riding). I refrain from getting involved in any rough and tumbles. I get very itchy arms that are impossible not to scratch. I need to travel with the pillow or perhaps similar substitute. And every other month, something gives in my neck and I need to be bed bound for about a week to manage the pain and limited mobility. After my initial healing from whatever trauma that caused the inflammation (unknown), it is unlikely that DDD will get better over the years. It is necessarily going to get worse.

So what can be done about it? Well treatment options have been limited. Either one commits to full blown and very invasive surgery, either fusing the spine around the disc with metal screws or replacing the disc itself with an artificial metal one.

Results of artificial disc replacement.

Results of artificial disc replacement.

However, even choosing the best hospital/surgeon/technique for ADR has around 15% complication rate ranging from worse results to death in the worst case. Fusion also often introduces problems with discs above and below. Deciding whether to go ADR or fusion is another hairy issue¬†which I won’t get further into here. If you don’t opt for surgery, you can opt for lifestyle changes like quitting smoking (never been a smoker), or lose some weight that may improve or worsen your results. Please don’t suggest going to a chiropractor… There is also steroidal injections into the spinal fluid column, but the consensus is they are only palliative.

Enter Stem Cells.

You constantly hear about the promise of stem cells but they became real for me when I saw the incredible, if anecdotal results of a man growing his finger back.

Naturally it seems obvious then to investigate how they are using this technology to treat DDD.

Stem cells have been known for a while to treat a variety of diseases but even in 2012 NCBI scientific review papers suggested promising but inconclusive results for disc degeneration.

The paper mainly deals with the conclusions about animal studies, which are more positive for smaller animals than bigger ones. The spine is an inhospitable place for cellular activity given that not much blood flow gets in there which carries vital nutrients for cell growth. So early work was right to be sceptical… but we now have more data than that.

While reading about some amazing techniques in this regards involving animals, I found out that injecting stem cells had already been used in phase 2 human trials by an Australian company called Mesoblast. The results were really positive and they were applying for the final phase before approval. That didn’t really help me now though, as that probably meant that a product for people would be around at 2016 or 2017 at the earliest for lumbar (lower back) region. Even later than that for cervical (neck) use.

Then I read the article which I mentioned in the beginning which is an interview with medical analyst Jason Kolbert. From the article:

TLSR: The therapy that you had administered did not have to be approved by the FDA. There is an exemption for minimally manipulated biological tissues. No premarket approval (PMA) or even 510(k) clearance is necessary. Correct?

JK: That is exactly correct. In the case of IntelliCell BioSciences, cells are extracted from adipose tissue, but there is no collagenase (collagen enzyme) added to digest it. The company essentially applies sonification (ultrasound) and separates out the stem cells. Within an hour it reintroduces the cells to the patient. Because cells are so minimally manipulated and because the entire process is done onsite, in the room adjacent to the patient, it likely qualifies under the FDA exemption that allows physicians to treat patients at their discretion as a “practice of medicine” issue.

Essentially it means that if the Stem cells are harvested from me, rather than another person/animal etc, they are not considered a drug by the FDA and can be re-administered as therapy. That meant I could instead be searching for surgeons prepared to treat me today! Turns out that this has already been happening and even some high profile cases. In fact governor Rick Perry has come under scrutiny for being treated for back pain by using Stem Cells.

rickperry

I’ve already been turned down by my surgeon in Cape Town for exploring this approach. I respect the conservative impulse of doctors, but that doesn’t mean that they are right from the perspective of the patient. The data and incentives are complex here, for example look at an extract of Jason’s interview.

TLSR: I have one last question. What’s to stop an anesthesiologist or neurosurgeon or orthopedist who treats back pain from extracting a stromal vascular fraction and treating their patients? How is that going to affect Mesoblast and others who have gone the long route with the great expense of clinical trials?

JK: There is nothing to stop people from doing that. But the caveat is that once a product is approved and has a label, things change. Imagine that two patients are treated, one with the Mesoblast product and one with the do-it-yourselfer. Let’s say something goes wrong with the do-it-yourselfer, and that patient’s pain is not ameliorated. It gets worse, and a fusion is required. The patient calls a lawyer, and the lawyer sues the doctor. The lawyer asks the doctor why he used an “unapproved do-in-yourself” therapy versus the FDA-approved product. That’s not a position I would want to be in as a treating clinician.

Once there is an approved therapeutic project, the do-it-yourselfers tend to go away. Therefore, we don’t see these as a fundamental threat to companies like Mesoblast or Cytori Therapeutics Inc. (CYTX:NASDAQ) because once clinical trials are completed and the product is approved, clinicians will use it.

In other words, the risk adjusted return to the patient given the data, may not be the same as the risk adjusted return to the physician. That also assumes that all people do and should have the same risk tolerance, which I don’t think is the case. There have been very few complications that I know of regarding Stem cells. The only¬†horrific case publicized that I know of happened to a woman who had Stem cell botox around her eyes. However the doctor screwed up and administered other botox agents besides the stem cells which had the effect of confusing the cells into growing into bone.

So where to next? How do I work out who is a cowboy and who isn’t? How can I work out which teams are mindful of the research as it’s changing (as in the dosages of Mesoblasts trials, or the fact that adipose stem cells may be different than bone marrow ones), and which ones are selling a product they are merely comfortable in performing, but which may be ineffective? Or worse that they aren’t competent in performing? That’s the difficult part.

Here are some leads in no particular order.

Reganadisc at the laser spine institute. Although he seems to certain about the outcomes in the video, and apparently sites touting patient experiences aren’t to be trusted.

Dr Joseph Meyer in Colorado¬†who uses bone marrow, at least he is upfront about his patients who felt it worked and those that didn’t (by the numbers).

… I will add to this list as I increase my research.

Additional information: This may be the best summary of the scientific research before the Mesoblast trial. The unfortunate reality is that on the one hand they want to take more care given potential hypothesized risks… but on the other hand they admit that the longer one waits, and the more deterioration that occurs of the disc and the end plates, the more unlikely it is for patients to reap the benefits of stem cell therapy. This puts me in a bind, one that I personally would prefer to err on taking the risk given the best practises today, with the knowledge that I could potentially fall back on ADR/fusion if it doesn’t pan out.

Here is another interesting take on the delivery mechanism of cell therapy for DDD from Duke University. The researchers suggest that up to 100% of the injected cells leak out of disc using traditional methods of injection. Although it’s noted that they didn’t use stem cells but specifically cultured disc NP cells. Possibly, this may suggest why although Mesoblast’s results are positive, they aren’t stellar as they could be. Here’s a surgery that seems to think they’ll be able to employ these techniques soon, although I don’t see how in the USA.

Here’s a patient for whom stem cell therapy didn’t end up working. He ended up travelling to the UK to have ADR on his lower back.

Here’s the story of a pro football athlete who ended up having a spinal fusion on a cervical disc, but had stem cell therapy that may or may have not worked.

 

 

 

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