Hello all, Dr. Crusoe here!
I'm pleased to say we finally have an update on how funds from my IVDD FUND at Cornell University will start to be used!
As you know, over the past year since I launched my Crusoe IVDD Fund at Cornell University - a fund set up to exclusively raise money for IVDD and spinal cord injury research and clinical trials.
Through the fundraiser, with the help of many of you, and by fund matching $20,000 ourselves together with our dog ramp brand of DoggoRamps, we raised a total of just over $170,000.
This was amazing in itself, and already would be enough to fund some very meaningful research. Yet, as a testament to the love and goodwill Crusoe has brought over the years to his millions of fans, there was still more to come.
One fan of ours - who has been especially touched by the joy Crusoe has brought over the years - and who humbly wishes to remain anonymous, has gifted $1,000,000 towards our IVDD FUND!
So, we are incredibly thankful to this fan for this amazingly gracious donation, but equally so to every single person who contributed what they could. There is now enough funding to support multiple years of meaningful research and early-stage trials for IVDD and spinal injury.
We are so incredibly proud to have this significant contribution as part of Crusoe's legacy. Cornell is likewise very thankful to us, and all of you, and gifted us this signed frame by their doctors, practitioners, and students.
And finally, I am excited to share with you the details of Cornell's first study design that they will be conducting!
So let's get to it!
Cornell's IVDD Study Design:
Firstly, I know you know what it is, but allow me to super quickly recap what the actual disease process of IVDD is, as that will help to understand the goal of the study.
What is IVDD? 🦴
The discs between our vertebrae, and those of dogs, are like little donuts with jelly-filled interiors, acting as cushions to allow movement of the spine. IVDD, or intervertebral disc disease is when these discs deteriorate quicker than normal, becoming dehydrated and calcified over time. In many breeds (especially dachshunds), genetics play a major role in why this degeneration happens early.
During the disease process, the fibrous exterior of the discs becomes brittle, and - especially through shock-impacts (ie. jumping on or off things) - they can then bulge or even burst open, where the jelly-like interior can spill out.
Unfortunately, this bulging and bursting action usually goes upward into the spinal canal area, where it can push on and constrict the spinal cord and/or nerve roots. Depending on the extent, this can range from pain to complete paralysis.
So IVDD involves more than just the degeneration of discs. It causes spinal cord injury, which is of course the most debilitating and heartbreaking part of the picture. So there really are two very separate areas of study involved, both exceptionally challenging.
But if the degeneration of discs could ever be prevented or reversed outright, it would prevent the subsequent spinal injury.
Study Design: Overview💡
When it comes to IVDD & spinal injury, there are a million different angles that could be explored and studied. And at the end of the day, you have to pick one!
So, the question Cornell seeks to explore and answer with their first study, is if something could be done to slow, stop, or potentially reverse the degeneration process of diseased discs.
As IVDD very often involves an inflammatory component in and around the discs as they deteriorate and cause problems, the anti-inflammatory component here is seen as a crucial and differentiating aspect of this study. Previous studies have been done where stem cells have been injected in discs, but the effects and survival of these cells has been short-lived. It's thought that the inflammatory disc environment is what limits survival and long-term integration of the injected cells.
Their proposed study design involves two distinct phases.
Study Design: Phase I 🧪
The first phase will take place entirely in the lab (in vitro), where stem cells will be induced to become notochordal-like cells (a key cell type associated with healthier discs, especially in early life).
At the same time, they will take diseased disc material and work to characterize the inflammatory factors in it (determine the specific cytokines, etc). Cornell plans to culture the tissue in a petri dish to understand the inflammatory processes, which is a method that has worked well in human studies.
Once they can identify the inflammatory factors from a real disc, they will then bring these two parts together experimentally, meaning they will use the characterized cytokine environment from the disc tissue with the fresh notochordal cells to test how these cells behave. They will be challenging these notochordal cells to survive and grow in true disc-like inflammatory conditions.
The goal is then to test various ways of helping those cells survive longer and better by introducing various anti-inflammatory methods. So this may include drugs like NSAIDs, but could also be done with monoclonal antibodies, etc.
We may even send Oakley there to assist, since he's pretty good in the lab himself.
If and once a successful protocol is found, it will proceed to Phase II.
Study Design: Phase II 💉
The second phase will involve a clinical trial (in vivo), where select dogs with IVDD will have their degenerated discs injected with notochordal cells alongside whatever anti-inflammatory strategy they develop.
The dogs will be followed clinically and with MRI imaging before and after treatment, and for a certain follow-up period to assess the results.
The nice thing is that you can pretty clearly see a degenerated disc on an MRI, and likewise would see measurable changes to a disc, such as improved disc structure, hydration (plumpness), and even reduced protrusion (bulging).
Just getting to this phase may take 1-3 years, as the Phase I results need to be strong enough to justify the cost of imaging-heavy clinical follow-up. Repeated MRIs are one of the biggest cost drivers, and that's why the early lab work matters so much.
What does it mean for dogs at the end of the day?
Well, let's examine.
If a disc is inflamed, bulged, etc, it may be at the point where it is causing pain and potentially some level of nerve irritation or compression. By improving the health of the disc, it not only reduces the inflammatory environment in and around the disc, but disc bulges and protrusions can potentially retract/improve a degree as well, thus putting less pressure on nerves/spinal cord. So although it won’t directly regenerate severely damaged nerves overnight, it could reduce ongoing irritation or compression, which may allow some nerve/neurologic recovery depending on the case.
Furthermore, beyond improving a dog's current condition/discomfort/neurologic state, this proposed treatment would hopefully improve the health of the disc into the future as well, where it may become less prone (or slower) to degeneration and disease.
And I think that is the ultimate direction of where this is going - where at the earliest signs of IVDD, a procedure like this could be undertaken in a dog to improve the condition of their discs to slow, stop, or reverse progression of the disease.
Staying grounded & realistic ⚖️
As much as novel and groundbreaking research can be exciting, most scientific research happens as small steps, building on the previous work from others. This is for good reason, as it allows for research that is more prudent, economical, efficient, and likewise often more successful.
So that's what this study is. It is continuing and working off of past research from both dog and human studies, but now taking it a step further.
It's also important to recognize this study, especially Phase I, requires exploration (testing new and different things). So there will inevitably be challenges. It's not guaranteed they will find a strategy strong-enough to warrant going to Phase II. As mentioned, Phase II will be the most expensive part, so it makes sense to only undertake this if there is a certain degree of confidence from the findings in Phase I.
However, even if a good enough strategy is not found and there's no progression to Phase II, there still will inevitably be a lot learned through those trial and errors, and that itself will better educate and inform future studies.
However, I do have faith in the neurology and biochemistry teams at Cornell, and look forward to seeing their progress!
Some Disclaimers 🪧
Just to be absolutely clear, the study design by Cornell was something they entirely developed on their own through their internal meetings across their neurology & rehabilitation doctors. We exerted zero influence on the area of study or the design of the study. The only mandate there has even been, is that any research or study must be for the purpose of IVDD or spinal injury in dogs.
What do you think? 💭
Even if you're not a scientist or expert of neurology, we'd love to hear your thoughts!
All in all, it seems like a logical and intriguing step forward in the world of biologic medicine, and hopefully a meaningful step forward in the battle against IVDD.
Still looking to contribute?
Although we have raised a meaningful amount so far, funds still don't last long in clinical trials and research... If you'd like to add a contribution yourself to throw your bone into the fight, however big or small, do so through the secure link here. Donate to Crusoe's IVDD FUND at Cornell
Thanks for reading and following along. We'll let you know future updates might be anticipated.
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