Everything we knew about rehab and research is being turned on its head. Rehab is no longer a once-and-done deal — function can be improved upon, and people are already healing from spinal cord injury. Are we talking cure? No. But we are talking about regaining abilities.
Interview with Wise Young by Seth McBride
NEW MOBILITY: When we contacted you for this story, you sent an email about why the dogmas of SCI research are slow to die. Can you explain these dogmas?
Wise Young: The first and most influential dogma is the belief that the spinal cord does not regenerate. Hundreds of published studies have shown that the spinal cord not only can, but does regenerate. In fact, the more severe the injury, the more regeneration occurs.
The second and sister dogma is that people do not recover from spinal cord injury. This is false. People with incomplete injuries usually recover substantially and even people with complete injuries will recover partial function.
NM: If the spinal cord is able to regenerate, what has been holding people with spinal cord injuries back from recovering function?
WY: We did a study in China [published in 2016] using umbilical cord blood mononuclear cell transplants combined with an intensive locomotor training program — six hours a day, six days a week for six months. That study showed that 15 out of 20 people with complete SCI recovered long distance walking, as well as bowel and bladder function by one year after the start of treatment. In that trial, there were eight who received the UCBMNC transplants but no locomotor training. They did not recover walking, bowel or bladder function. This was like a control group of sorts. The message was clear — no exercise, no recovery.
We did another study that should be published soon, which involved 30 subjects. All received the same intensive locomotor training, and half received a surgery to remove all adhesions, clean the spinal cord and surrounding membranes. This is called untethering. None received any cell transplants. About a quarter of them recovered walking, but a majority showed improved bowel and bladder function. The two treatment groups showed no difference in walking, but the untethered group had better bowel and bladder recovery. I think that trial showed us that walking by itself is beneficial. (For more on untethering and Dr. Young’s research, don’t miss NM’s October cover story.)
If we think about it, these findings are really not so surprising. Animal studies have shown for a long time that spontaneous regeneration occurs in the spinal cord and that transplanted cells can improve the regeneration, but the regenerated axons are very unlikely to make exactly the same connections. Training is necessary for the brain to learn to interpret sensory signals and how to use the new connections.
NM: Were there any other notable findings from these recent studies?
WY: One aspect of the studies was really unexpected — age and time after injury did not seem to make a difference. People that were in their 50s and 20 years after injury recovered as much and as well as those who were in their 20s and two years after injury. If you had asked me before the study whether age or time after injury would affect regeneration and recovery, I would have responded that both would be important. This finding suggests strongly that the spinal cord is ready to regenerate and to recover function even 20 years after injury and in older patients.
NM: For decades, SCI recovery had been framed in terms of a “cure,” as if recovery was going to come in the form of a pill or a surgery that suddenly restored full function to a paralyzed body. What is a more accurate way to view restoration of function?
WY: The spinal cord injury community has been really disheartened by the continual barrage of media reports that the cure for spinal cord injury is here, only to find out that it won’t be available for another five years — they called this “the rolling fives.” Although we’ve published these studies, we made the choice not to publicize them, instead explaining the results with individuals and groups within the SCI community. We need to explain how this recovery works so that people don’t misunderstand that it’s not a cure. We’re not talking about miracles here. Recovery in spinal cord injury can be helped by certain therapies and requires a huge commitment on the part of the people with SCI and their families to do the locomotor exercise, which is the most intensive exercise they’ll ever have. To take somebody who’s 20 years after spinal cord injury and expect them to walk without intensive training, that’s expecting a miracle to happen.
NM: Where does your research go from here?
WY: We’re trying to get worldwide regulatory approval. We have a trial that will be starting in the U.S. within the next six months that has already been approved by the FDA as a phase 2 clinical trial. This will be the first trial in the U.S. using umbilical cord blood cells transplanted into the spinal cord, and this is the most intensive walking training program ever, and we have to show that it’s feasible, that it can be done.
Phase 2 trials are preliminary to establish the feasibility, optimal dose and optimal outcomes for phase 3 trials. Generally, one does phase 2 trials until one is pretty certain that the phase 3 trial will succeed. Then we would go ahead with the global phase 3, which is the pivotal trial that forms the basis for regulatory approval.
NM: You’ve said that getting regulatory approval may be the only way for people to start thinking beyond the dogmas and accept that regeneration and recovery are possible. If things go well, and you’re able to get approval, how does that change the SCI research and clinical world moving forward?
WY: Big Pharma will take an interest. Right now they have no interest, they don’t believe this can happen. Even after we published our study in 2016, there have been three clinical trials in the United States involving cell transplants into the spinal cord, and none of these three studies have employed intensive training. These three U.S. trials involved a number of different cells, and all resulted in no recovery of function. I don’t know that their cells didn’t work. All I know is that if they put in cells without walking the subjects, they’re not going to see improvements in walking.
NM: Would you expect that if researchers start to include locomotor training or other activity-based training into their studies, then all of a sudden, we’re going to start seeing a lot more successful studies for regeneration?
WY: Absolutely. I believe that. I don’t think that umbilical cord blood mononuclear cells are the be all and end all of spinal cord injury transplant therapies. A lot of different therapies are showing some beneficial effects. There have been more than a hundred studies published in China in the last four years using transplants of a variety of cells into the spinal cord, and in every study, you notice that maybe two or three or four people are actually recovering well, and these are the ones who are highly motivated to walk.
It is a very exciting time in spinal cord injury research and for the spinal cord injury community. I suspect that what we have found in spinal cord injury applies to many other neurological conditions, including traumatic brain injury and stroke.
Interview with Janne Kouri by Seth McBride
NEW MOBILITY: Research is increasingly showing the benefits of activity-based and locomotor training. But access to this type of training is extremely limited. What is the biggest challenge with providing quality functional rehabilitation in the U.S.?
Janne Kouri: Lack of insurance coverage. The reason there aren’t a lot of community-based facilities is they’re expensive to run. Equipment is expensive, staffing is expensive. Locomotor training takes four trainers working with one client. At our NextStep facilities, we have a lot of high-level quads who are newly injured, and some have vents. Activity-based training with those clients sometimes requires three trainers. It’s very expensive. Right now, the only way to make these centers affordable is to operate as a nonprofit and do a lot of fundraising. It’s not easy.
NM: So insurance companies don’t want to pay for this type of training because it’s expensive. What’s your argument to them as to why they should cover it?
JK: They’re going to save billions of dollars. It’s really simple — if you have access to rehab and fitness services, you’re going to be healthier, you’re going to recover more, you’re going to require less medication, less equipment, you’re not going to have to go to the doctor’s office as often and are more likely to stay out of the hospital with pressure sores, diabetes or other complications.
We gather data on every one of our clients’ sessions to show their progress. And all of the data has been entered into the Reeve Foundation’s NeuroRecovery Network database, along with data from the five hospital-based rehab centers and the community-based facilities that are part of the Recovery Network. Also, every six months, our clients do quality of life surveys, as well as answer various questions about overall health and wellness, medications and doctor’s visits. We’ve got troves of data showing that what we’re doing is working. Every client is different, but for almost anyone, the more training, the better functional outcomes, so the investment is worth it.
We’re trying to put the full court press on insurance companies. There are a lot of people advocating for this — obviously United Spinal Association and the Christopher and Dana Reeve Foundation have been working on it. There’s a lot of data out there, and there’s a ton of research proving that the methods we’re using work. It’s all there. I don’t know why insurance companies haven’t seen the light yet, but we have to keep pushing.
NM: There’s a lot of exciting new research showing that recovery of function is possible, given the right interventions. Whether it’s electrical stimulation or some of the more ambitious regeneration strategies, activity-based or locomotor training seems to be key to helping the spinal cord rewire itself after injury. What do you see your role being as some of these recovery technologies move from research trials to clinical applications?
JK: Dr. Susan Harkema and others are already seeing some amazing results from epidural stimulators, and as they continue the research and implant into even more participants, I think we’re going to see even more improvements in recovery of function. So far they’ve gotten people to stand, and one girl got back to walking. We’re seeing improvements in bowel, bladder and sexual function.
We simply took the rehab techniques and methodologies that places like Frazier Rehab Institute [where Harkema does her research], Kessler, Craig and Magee employ and brought them to a community-based setting. As these treatments move into the clinical setting, it will be amazing to start working with people who’ve had them and seeing what kind of functional improvements we can get. People can continue to see improvements for a long time, so having access to community-based therapy is going to be really important for maximizing the functional return that people get from these treatments.
By Kelly Spellman
Photos by Joe Stone
In our current medical system, rehabilitation is front-loaded for people with spinal cord injuries. Immediately after their injury, they have access to skilled interdisciplinary rehabilitation services, though they’re often unable to fully benefit as they’re grappling with loss, coping with pain and facing major changes in nearly every aspect of their lives.
After that first wave of rehab, further access to specialized services typically only occurs following some sort of injury, wound or major setback. This mismatch of when services are available and when people are ready to make changes in their lives often leads to people exhausting their access to rehabilitation services before they meet their full potential.
Here’s How We Do It
At Empower SCI, we strongly believe that we need to create different avenues for intensive rehabilitation and learning for those who are not able to absorb the skills and information provided immediately after injury. In our post-acute rehabilitation model, people with SCI who have had their injury for at least one year receive comprehensive residential rehabilitation services in a week-long program. They determine their own goals, which are worked on around the clock with peers, caregivers, and therapists. They receive rehabilitation counseling to strengthen individualized coping skills and are provided with opportunities to challenge themselves through adaptive sports and social opportunities.
We are a volunteer organization, and our residential programs run for three weeks of the year, two weeks at the State University of New York at Stony Brook and one in Montana. Over the eight years that we’ve run this program, we’ve seen huge changes are possible in short periods of time when rehab services consider the whole person and meet them where they are in their post-injury journey.
We believe in bringing together existing programs and systems to provide holistic care that fosters a safe environment for participants to push past their current boundaries. For example, this year when we expanded to include a week-long residential program at the University of Montana in Missoula, we collaborated with its physical therapy department, recruiting its staff to be therapists and its students as residential aides. We partnered with peer mentors from Missoula’s independent living center and worked with local parks and recreation and adaptive sports programs. In this way, we were able to provide our participants with true interdisciplinary care while simultaneously connecting them to activities they can continue to participate in after the program is over.
Programs Like Ours Should Be Available Locally
Leaving one’s home and familiar routine to attend a residential program like ours can be a powerful driver of change. But in an ideal world, a person shouldn’t have to travel to access needed specialized services, nor should they have to be in a crisis to have those services covered.
We envision a medical system with a stronger focus on preventive care, where at an annual physiatry checkup, a person with SCI would receive a comprehensive interdisciplinary evaluation to monitor for secondary complications such as changes in skin integrity, seating and positioning needs, bone health or urinary care. That person could then be referred to follow-up services such as a seating clinic, nutritional counseling, a urologist, or physical and occupational therapy. A case manager could coordinate this care, connecting the person to services and helping them navigate our complex medical system. Making access to these services more routine could prevent medical issues that might otherwise spiral into costly and devastating hospitalization.
In addition to medical care, annual screenings should be included for services such as psychiatry, rehabilitation counseling and peer mentoring. These services are invaluable, as they provide the person with emotional support to move forward with changes in their life roles and career.
Unfortunately, these services are not often fully integrated into regular care, and more commonly need to be sought out. This limits recipients to those with greater resources or a better ability to navigate our medical system, and often fails to reach those who need these services the most. Incorporating this care into a routine check-up could help to jump-start a person with SCI’s ability to return to driving, employment, or independent living. For those who live in areas of the country where transportation is a barrier or services are limited, telehealth and short-term intensive programs like ours may play a vital role in filling the gap.
In the future, we hope that having access to a program like ours that provides comprehensive, specialized, holistic care when the individual is ready to make major changes in their lives will be the norm, not the exception.