I’ve been spinal cord injured for almost fourteen years. It’s refreshing to finally see therapies moving from making rats and mice walk, to potentially help some like myself walk again.

The Student Society for Stem Cell Research comments, ‘The FDA hearings are particularly timely, as Geron is expected to begin human clinical trials using embryonic stem cells for the treatment of spinal cord injury this summer.

“We are talking about weeks, not years, before we see the first clinical trials using embryonic stem cells. This is inspiring to our generation and empowers our hope that the next generation will not have to endure many of today’s dreaded conditions for which stem cell research holds promise,” said Marion J. Riggs, SSSCR Founder.’

The human clinical trials proposed by Geron will be conducted on “acute”, or newly injured individuals.

“* The Reeve-Irvine Research Center (RIRC) has treatments in development that address all 3 phases of SCI; acute, sub-acute and chronic. Since SCI represents a population too small for drug companies to consider profitable, RIRC scientists, like Dr. Hans Keirstead, find characteristics that SCI has in common with other conditions. By grouping these conditions together, 2 important goals can be achieved for people with SCI:
o Create a large enough population to be profitable to big pharma;
o Shorten the trial length of each treatment. Instead of following a person with SCI for 10 – 20 years or more for data, they can use shorter trials in these other conditions.

* Safety studies with IP10 antibodies in ulcerative colitis should report soon. FDA approval for UC will allow this drug to be used off-label in Acute SCI. In animal models, as much as 70% return was noted when IP10 antibodies are given within 6 – 10 hours of SCI.

* In early 2008 Geron is planning to file an IND with the FDA and undertake safety studies using differentiated stem cells that form oligodendrocytes (these remylinate the spinal cord). The Phase I trial will be for people with new SCI, 1-2 weeks post injury.

Multiple studies addressing chronic SCI are underway at the RIRC:

* Animal testing with human embryonic stem cell derived motor neurons is underway. Human clinical trials await FDA approval – those discussions begin January, 2008. The first trials will likely be for infants with SMA-1, and then adults with end-stage ALS. This treatment is also for chronic SCI, without limit to the age of the injury. Decades-old SCIs may benefit from the treatment. The Geron experience taught Dr. Keirstead and team, which is moving the hESC motor neuron therapy forward, a great deal about the FDA approval process and they have been able to streamline their processes to move through the FDA system faster. This will be beneficial to the chronic trials.

* RIRC Director, Oswald Steward, is currently testing FDA approved drugs in chronic cervical SCI models. These drugs were developed for other applications, like heart disease and cancer, but have been found to be neuro-protective in fish models. Dr. Steward is testing 7 drugs now, but has many more ready to go. If any of these show efficacy in rat models, we can very quickly, in a matter of months, go to humans in a Phase II trial because the FDA has already determined them safe.

* Dr. Kim Anderson works with care issues such as sexual dysfunction and the metabolic effects of SCI that make us more prone to diabetes and other conditions. She discussed her current pilot study regarding diabetes in the SCI population.

* We have often talked about how funding is THE obstacle to curative therapies. Dr. Keirstead was careful to point out that funding is not the only issue. FDA approvals also play a pivotal role in how fast or slow a therapy will be tested

* If FDA approvals go as planned, we can reasonably expect chronic SCI clinical trials in humans in 2-3 years with treatments potentially available in as few as 5 years. These predictions are dependant on several factors: funding; FDA approvals and efficacy in humans to follow previous animal models.

* Research for Cure accepts donations for RIRC and Dr. Keirstead.

* Hopefully, everyone reading this will be inspired to raise funds and awareness for SCI research. Tania Cusack and Dr. Maura Hofstadter are the contacts at RIRC that can help with fundraising and research questions.”

Some background on me… I’ve used the Medtronic intrathecal pump since 1995 (Well, I’m actually on my third pump, due to battery replacements). Up until the last two years, the only medication I’ve used in the pump, has been baclofen. This drug has helped my leg spasms, and back tone.

I started having pain in my lower back and legs, that was not allowing me to sleep. I’ve always had some type of pain, but it’s been tolerable (the burning in my legs in 1995 was anything, but tolerable. Thank God that went away. That’s another story though). My doctor recommended combining the analgesic narcotic, Dilaudid in my pump, with the baclofen. Dilaudid is similar to morphine, but has less side effects. I’m currently on a small dose of 0.3093 mg/day.

So, I’m getting a refill of drugs last week, and my nurse informed me that the Dilaudid could affect my testosterone level. She said, after time, the drug lowers the level of testosterone output in the body. This can lead to depression, loss of sex drive, apathy… you know, the usual stuff. I’ve been feeling as fine as a paralyzed guy can feel, so wasn’t to worried about it. It’s good to know though. She had one patient that had less testosterone being produced than a corpse. They gave the guy some type of hormone medication, and he feels like a new man.

Narcotics in the pain pump will affect estrogen levels in ladies, so another caution there.

I don’t like taking medications, but sometimes you must. Trying to tolerate pain, or spasms, can wear a guy out. The pump has helped me feel better. Knowing the side effects those drugs produce will help me stay that way.

What caught my eye was how he received hypothermic treatment immediately after his injury.

“Green said the key was the quick action taken by Cappuccino to run an ice-cold saline solution through Everett’s system that put the player in a hypothermic state. Doctors at the Miami Project have demonstrated in their laboratories that such action significantly decreases the damage to the spinal cord due to swelling and movement.

“We’ve been doing a protocol on humans and having similar experiences for many months now,” Green said. “But this is the first time I’m aware of that the doctor was with the patient when he was injured and the hypothermia was started within minutes of the injury. We know the earlier it’s started, the better.”

Cappuccino said Monday that the 25-year-old did have touch sensation throughout his body, showed signs of voluntary movement and was able to breathe on his own before being sedated. But he cautioned that Everett’s injury remained life-threatening because he was still susceptible to blood clots, infection and breathing failure.”

I went to the Miami Project a year after my injury, and participated in a few studies. This really makes sense. If they can slow down the swelling of the spinal cord, (which causes more damage) the injured person has a greater chance at keeping function.

I’m not a medical doctor, or researcher, but it seems it would advantageous to put a spinal cord injured person in that hypothermic state as soon as possible. Will emergency rooms be equipped with this possibility in the future? Maybe.

“I am pleased to report that the Seventh Annual Research for Cure Dinner was a huge success, due to 1. Dr. Keirstead’d presentation plus his easy manner of cruising through the attendees, allowing everyone an opportunity to speak to him about their own concerns. 2. The efforts of a growing number of volunteers.
Below is a brief synopsis of Dr. Keirstead’s presentation. It lacks the details and the excitement that Dr. Keirstead has for this work, which is quite contagious.

Keirstead worked with Dr. Thomas Lane at UCI, whose interest is multiple sclerosis, to develop a means of reducing the inflammatory response immediately after trauma or injury to the nervous system. Together they developed a treatment for multiple sclerosis, which Dr. Keirstead’s group then adapted for use in acute SCI. A phase 1 clinical trial began in 2006 on individuals with ulcerative colitis (same inflammatory mechanism that causes degeneration), and is funded by Medarex Corporation.

Using hESCs, Dr. Keirstead’ team has had great success turning them into oligodendrocytes, with a purity level above 95%. Injection of the cells into sub-acute paralyzed rats (within 2 weeks of injury) resulted in improvement of function. Four other laboratories replicated this approach. Clinical trial dates have been pushed forward several times, as this will be the first hESC therapy clinical trial and safety is the primary consideration. Being the first trial, new procedures and standards have been created and revised and revised again. Clinical trials are now scheduled to begin in 2008, and will be funded by Geron Corporation.

Dr. Keirstead also has a team working on scar tissue removal. Scar tissue is the reason that the oligodendrocyte treatment outlined above will only work on acute injuries - there is no scar tissue in acute injuries. If the scar tissue is removed, the sub-acute injuries become like acute injuries and treatments successful on acute injuries may be successful.

Chronic studies are being pursued with a passion equal to my own for treatments. Motor neurons, in conjunction with cAMP and a “designer” virus, is hoped to restore function in chronic SCI (months to decades after injury). This is another wonderful example of collaboration equaling faster answers to recovery treatments. Dr. Keirstead and collaborators from California Stem Cell Inc. have put their knowledge together and now can produce clinical grade human motor neurons in large volumes at 95% purity. Dr. Keirstead has provided these cells to Dr. Doug Kerr at Johns Hopkins, and both have both begun animal testing. Because of Dr. Keirstead’s experience with the FDA during his work with Geron Corporation, the path now exists to move through the process much quicker. The first human trials are planned for babies with spinal muscular atrophy. These poor babies generally only live about 12 months, and die as a result of motor neuron death within the spinal cord. There are currently no treatments for the disease. The trials would be relatively quick, as the babies’ lifespan is so short. As with other clinical trials, once a treatment has been proven safe for humans, it can be used for other conditions.

We all left with hope, based on science and, hopefully, a desire to help politically for increased funding for hESC research, or a desire to volunteer time in efforts to raised money or, if able, donate money towards this exciting research OR all three!”

Thanks Karen!

‘I have been doing spinal cord injury research for 30 years. The first half of my career was spent on developing treatments for acute spinal cord injury and the last half has been on regenerating the spinal cord. When I first started in the field, doctors and scientists were very pessimistic. Most of my time and effort was spent trying to convince them that something can work. The second half has been different. The 1990’s was the decade of the spinal cord. Scientists became convinced that the spinal cord can regenerate. Doctors are not yet convinced but most of them are not in touch with the latest research in the area. However, people in the spinal cord injury community heard about the therapies, particularly stem cell therapies.

In the past decade, since 1997, many clinics, such as those in Mexico, China, Bahamas, Portugal, and India began advertising stem cell therapies for spinal cord injury. They charge about US$20,000-$30,000 for unproven therapy. People flocked to these clinics, often not knowing what they are getting. These places do not publish their work. Some do not even bother to get followup studies on the patients. Many have invented some kind of repeat procedure in order to get the patients to come back to the hospital and so that they can charge more for the therapies. When asked to provide details about the treatment, these places are reluctant to provide the information. These are pathognomonic signs of a scam.

In the meantime, many legitimate and scientifically based therapies are being developed by scientists. Dozens of therapies have been shown to regenerate the spinal cord in rats. Some of these therapies were beginning to go into clinical trial in the late 1990’s. The attack on 9/11/2001 unfortuantely diverted the attention of the United States. Since 2001, funding sources for spinal cord injury clinical trials dried up in the United States. Industry was not willing to invest because they thought that spinal cord injury is a small market. Christopher Reeve did a great job building up the private fund-raising for spinal cord injury research but his untimely death left us with very big shoes to fill. The main source of spinal cord injury funding is the NIH and they have been cutting back funding of research, for example NIH spinal cord injury research funding declined from $84 million in 2005 to $64 million in 2006.

Instead of joining forces and pressing our government and industry to invest in spinal cord injury clinical trials, many people in the spinal cord injury simply gave up. Some decided to go overseas for their therapies. You have read about many of those on these forums. However, some decided to lobby for research. In 2005, several hundred people went to the first rally in Washington DC to press Congress to fund the Christopher Reeve Paralysis Act. We have subsequently gone two more times but I want to point out that this was really the first major effort by the spinal cord injury community to push for spinal cord injury research funding by the government. While there have been many successful efforts lobbying the govenrment for ADA, rehabilitation, veteran administration, and home care issues, lobbying for spinal cord injury research and particularly clinical trials is a relatively new phenomenon.

Many, like yourself, blamed the problem on the FDA. In my opinion, the FDA is not the culprit. They apply the same standards to spinal cord injury therapies as to all other diseases, including AIDS, MS, Parkinson’s disease, Alzheimer’s disease, depression, etc. The FDA sets tough safety and efficacy standards but this is what the American public wants. Do you remember the COX-2 inhibitor Vioxx scandal. This was one of the best drugs for arthritis and joint pain. Then, it turned out that people who received prolonged (many months) high-dose Vioxx had a slightly higher risk of strokes and heart attacks. There was enormous public pressure on the FDA to force Merck to withdraw Vioxx. Merck voluntarily withdrew the drug.

The American public wants to eat their cake and have it, too. There is no such thing as complete safety and miraculous efficacy, and yet people seem to expect complete safety and miraculous efficacy at the same time. During the AIDS crisis, the FDA tried to come up with some compromises to the long bench-to-bedside gap. They invented a category of approval called “compassionate use” for situations where there are no other effective therapies. Spinal cord injury would fall under this category if any company or doctor ever wanted to get more rapid approval of a therapy. For example, the alternating current electrical stimulation device tested in Purdue was just approved on a compassionate use basis after a phase 1 trial. So, there are ways to move therapies faster through the bureaucracy. The problem is that very few clinical trials are going on in the United States. The government is not funding clinical trials. The industry is not funding clinical trials. Foundations are not
funding clinical trials. Is it any wonder that we don’t have few spinal cord injury clinical trials in the United States? The solution is to get clinical trials going in the United States.

What does it take to get clinical trials going in the United States? First, we must convince the government to fund clinical trial networks. Such networks reduce the cost of clinical trials and encourage industry to invest in spinal cord injury trials. Note that the government has long funded clinical trial networks for many conditions, including cancer, multiple sclerosis, and even for traumatic brain injury. It has never funded a spinal cord injury clinical trial network. The Christopher and Dana Reeve Paralysis Act is asking for modest funding for such a network. Second, the community has to help recruit and educate the doctors. Wait, you say… how come that is the responsibility of the community? It is because nobody will do it for you. Doctors are always behind on the latest research. After leaving medical school, they just don’t have the time to keep up with the latest research. It is up to the community to recruit them and teach them. Third, people need to help fundra
ise for spinal cord injury research. Most people don’t realize how much their neighbors, friends, relatives, and many people they don’t know care about curing spinal cord injury. It is a shame that we can’t raise more than $15 million per year for spinal cord injury research in the United States. We should be able to raise $250 million per year. That would go a long ways towards cure.

You are probably thinking that all this will take a long time and how will it help you. I agree. It will take time. But, if we keep postponing getting the cure movement started, it will never happen. I believe that we would have had the cure by now, if the spinal cord injury cure movement had really gotten underway twenty years ago. There were people at that time who tried, i.e. the American Paralysis Association. However, they were never able to attract more than a small fraction of the spinal cord injury community. I have heard every excuse why the cure movement has not yet happened. These excuses range from we are too small (AIDS movement was way smaller than we are when they started) to nobody cares and there is no money (these are simply not true). But, in reality, we don’t have the cure today because the spinal cord injury community has never truly believed that there would be a cure, never took the time to understand the science behind the cure, and kept on thinking th
at somebody else would do it for them.

I started Spinewire in 1997 (the precursor to CareCure) in order to provide information to the spinal cord injury community about themselves and their condition, so that they can advocate effectively for the cure. I believe that the community must lead this effort. The community must understand what is necessary to make the cure happen. No cure has ever occurred without the community. The polio vaccine occurred with the support of the March of Dimes and FDR. Note that the community were parents of children frightened of polio, not the people with polio. So, although the vaccine prevented polio, it unfortunately did nothing for the millions of people who were disabled by polio. The world trumpeted the cure of polio and all those people disabled from polio were forgotten. Some of the strong anti-cure sentiments in today’s disability community still emanate from memory of that abandonment. If you take the time to read the disability literature leading up to the ADA, you will see
how anti-cure people were. Many people in disability don’t want cure. They want societal support of people with disability.

Some of us have been working hard on ways to start small cure efforts around the world until the United States gets its act together. So, for example, I have spent the past three years organizing the ChinaSCINet which hopefully will be able to test combination therapies for spinal cord injury rigorously and efficiently. I believe that there will be clinical trials involving stem cells in California and New Jersey (as well as other states) by 2008. These state-funded approaches are necessary because the federal government has just dropped the ball. Finally, a number of companies are beginning to understand that spinal cord injury may be the gateway to the central nervous system and that if they can get their regenerative drug approved for spinal cord, it will be easier to get that drug approved for brain injury and stroke. Several large and deep-pocketed drug companies, including Pfizer, Novartis, Johnson & Johnson, Boston Life Science, and Biogen are beginning to invest in cl
inical trials. Several small companies, such as Acorda Therapeutics, Geron, and others are planning or doing clinical trials.

What can you do now? I recommend the following:
1. Take the time to understand spinal cord injury and the various treatments. I am here to answer questions and there are many people here with a great deal of experience. You need to understand things well-enough to make rationale decisions concerning clinical trials that will be coming.
2. Participate in lobbying your government to fund more spinal cord injury research and clinical trials. This can be in the form of letters or telephone calls. It is a long-term effort but it has to start.
3. You must prepare your body for clinical trial. This includes rebuilding your bone and muscle, getting your cardiovascular system up, and weaning down on any unnecessary drugs that you are taking. This will increase the probability that you will respond to whatever therapy.
4. Become educated and earn money. You probably think that I am kidding. I am not. Many studies have shown that the highest correlation with recovery from spinal cord injury is education and wealth.

I hope that the above helps.

Wise.’

Once again, President Bush has vetoed a bill that would allow NIH funding for stem cell research. His narrowminded view will only accomplish stalling medical research. His legacy will show a President more interested in allowing Americans to die, than live or be cured.

The Coalition for the Advancement of Medical Research (CAMR) writes, “With this veto, President Bush ignored the overwhelming majority in the medical, scientific, and spiritual communities who believe stem cell research holds the key to unlocking the future of better treatments and cures.

“With this veto, President Bush turned the page to start yet another chapter in a Presidential legacy of errors in judgment and bad decisions that needlessly cost American lives in the process.

“More than 100 million Americans suffer from debilitating diseases and disorders for which embryonic stem cell research holds great promise. Despite our anger and disgust at this second, most misguided veto, we will continue to do whatever we can to advance embryonic stem cell research in America . We will always be grateful for the strong, bipartisan support on this issue in both the U.S. Senate and House of Representatives, and among the American people.”

It’s a shame that stem cell research in the United States has been slowed down by the narrow viewpoint of one individual. If one of his daughters, or close family members sustained a spinal cord injury, I wonder if he’d change his tune.

2. Book the flight online to have all your tickets and information prepared.

3. Book a non-stop flight if possible.

4. Travel with an attendant if you can. Some airlines are good about helping you into an aisle chair, and some are horrible. Those aisle chairs are small and awkward. I’m 6′3″ and 220lbs. I can’t transfer to one independently. Without the help of my dad, I’d probably be still sitting on a few flights. Be clear with them early that you need assistance if you do. Even then, be prepared for them to not help. That’s my experience. They are often clueless.

5. Travel with gel-cell batteries if you have a power chair. Some airlines will refuse wet-cell batteries.

6. Sit on your wheelchair cushion. I ended up with a pressure sore on a long flight when I was unable to do decent pressure releases. Sitting on your cushion will help.

7. Get tagged at the gate. Tell them that you’d like to be tagged at the gate when you check in.

8. Take all removable parts off your wheelchair. Travel with a manual chair if possible. I saw one poor guy have his electric chair destroyed. Remove anything you can from the electric chair if you must use it.

9. Make sure your wheelchair is loaded on the plane. Obvious but crucial.

10. Report damages immediately.

Bonus tip: Have a fun trip. Good Communication with the airline attendants and other personnel will get you to your destination, and keep your wheelchair safe.

I was evaluated at the pain clinic in Seattle, and the test procedure worked. The rigid muscles in my legs relaxed. The pump was placed on my right side in the lower abdomen. I’m currently on my fourth medtronic pump. The battery in it eventually wears out and needs to be replaced. The pump is the size of a hockey puck, and can be used to control both pain and spasticity.

I have baclofen (Lioresal) in my spasticity pump for the muscles, and in the past year mixed Dilaudid with the baclofen to control neurogenic pain I was having. It did the trick, and helped relieve some of the pain. I know others will have morphine placed in the pump.

One thing that is alarming about the procedure of placing an intrathecal pump is the cost. About five years ago, I had one replaced by a neurosurgeon for around $15,000. I thought the hospital bill was wrong on my last bill when I saw it was over $30,000. A radiologist placed that medtronic pump. Medical costs are out of control.

If the quality of your life is being effected by pain or spasticity, look into the Medtronic intrathecal pump, and ITB therapy for relief.