The rise of stem cells as a possible source for restorative therapies is both hopeful and uncertain. In the age of instant information, faith in science runs far ahead of available therapies, making experimental procedures more alluring. But what about risk? Which procedures are safe? Which ones effective? In the summer of 2005, James Parsons, a T6 para, and his father, Roger, set out to gather all the information they could about the current state of restorative procedures for paralysis. In the process, they discovered an entire community of people who were just as eager as they were to find a cure.
Newly-employed and a recent college graduate, James Parsons, 22, was driving on the freeway in November 2001 when the SUV in front of him ran over a construction sign and sent it airborne. Parsons swerved to miss it, but his car rolled and skidded into a fir tree at the side of the freeway. Parsons, from Camas, Wash., was life-flighted to Emanuel Hospital in Portland, Ore., where three days later he regained full consciousness and learned he was paralyzed. Thus began his involuntary immersion into the world of spinal cord injury.
A little more than three years later, James and his father, Roger, a United Airlines overseas captain, began researching SCI restoration possibilities seriously. “We went on CareCure forum, all the sites that we could, and started compiling information,” says James.
Renowned Rutgers University SCI researcher Dr. Wise Young had initiated the CareCure Community website in July 2001 (www.sci.rutgers.edu). In an early poll, 75 percent of 84 members thought a cure for paralysis would be discovered in less than 10 years. One member complained that experts had been predicting a cure within five to 10 years since he was injured in 1990. A paralyzed Vietnam vet wrote from his [1960s] perspective: “The answer then was no way in hell can we fix your spine.” Others debated the meaning of “cure” or emphasized the importance of hope.
The Parsons learned about a surgical procedure in China performed by Dr. Hongyun Huang, a former postdoctorate fellow under Young at Rutgers. During one of his overseas flights, Roger arranged to visit Huang in Beijing, where he met a few Americans who were there for surgery. Roger concluded in an e-mail to James: “Everything I saw and heard there made me extremely optimistic about the procedure.”
One of the Americans Roger met at Xi Shan Hospital in Beijing was Aaron Dempsey, 33, a C5-6 quad who had been injured 15 years earlier. Aaron and his wife, Kendra, from Porter, Texas, had found numerous people treated by Huang on the CareCure website, among them Bob Smith, another C5-6 quad. “He was one of the main reasons that convinced us to go over there,” says Kendra. “He’s able to sweat now and has gotten quite a bit back.”
Those treated by Huang, on average, regain about two levels of motor and four levels of sensory return [each vertebra represents one level]. This amount of restoration can be more critical for a quad than for a para, since even modest gains might improve breathing capacity, arm or hand dexterity. “I’m not a real optimistic person,” says Aaron. “But once I finally talked to Bob Smith, I started to get excited.”
Huang has done as many as 1,000 OEG (see “What Does it Mean? below) procedures, including some on people with ALS, but evidence is mostly anecdotal and there is no structured follow-up. Published data is found mostly in Chinese journals. Both complete and incomplete SCIs are accepted for the procedure, timespan of injury varies widely, and supplemental treatments both before and following surgery are not consistent. However, Wise Young says Huang’s SCI procedure is considered relatively safe, although limited. Those with ALS, who receive OEG injections in their brains, also report moderate benefits, but these are temporary, and the procedure is riskier. When degeneration returns, the incurable disease runs its course.
The Dempseys corresponded with both Huang and Dr. Carlos Lima of Portugal [see "SCI Restoration: The Nose Knows," May 2005], whose techniques are related. Lima takes olfactory ensheathing glial cells from the person being treated and implants them into the spinal cord, while Huang uses OEG cells from aborted fetuses. Lima advised Aaron that he was not a good candidate because his injury was incomplete. Lima’s procedure is more invasive than Huang’s, and those with incomplete injuries have more to lose. Surgery always carries a risk.
Huang’s surgery costs $20,000 and airfare runs around $2,000. The Dempseys needed additional funds for intensive follow-up physical therapy at the Rehabilitation Institute of Michigan’s Center for SCI Recovery, where Americans are advised to go. It is crucial to maximize whatever benefits the surgery might make possible.
While at Xi Shan Hospital in November 2005, Roger Parsons also met David Landewee, who was treated by Huang and frequently returned to meet with him. Landewee’s progress impressed both Roger and James. “David Landewee looked like the one who had gotten the most back, so he was definitely the example of what could happen potentially,” says James.
Landewee, 45, from Liberty, Mo., a T4 complete para from a 1995 car accident, says his surgery involved incisions above and below the point of injury and injections of 500,000 OEG cells into the spinal canal at each site. “I started noticing some improvement in my abductors and hip flexors right away,” he says. For the next four weeks, he received treatments of acupuncture, massage and physical therapy six times per week.
When he returned home, he went to a rehab institute in Kansas City, Mo., where he stood and walked with braces and a walker for the first time. “I continued to improve for about 18 months. Then it leveled off. That’s what I got back — I could feel my stomach, my abdominals, my lower back.” At first, using a walker, he could cover 20 feet, but it was exhausting. “As it got easier, I could go about 100 yards with a walker, but it took me about 20 minutes, and I’d have to stop about every 30-40 feet.” He still stands and walks with braces and a walker, but only for exercise.
Landewee says he also got back feeling in his internal organs. “Before the surgery I would have bladder accidents, but I haven’t had one since the surgery,” which he attributes to better awareness of his need to cath.
Functionally, Landewee went from being a relatively high-level para to a relatively low-level para, but he still depends on a manual wheelchair. He says he’s glad he went to China but has become a little disappointed over time, which he thinks is normal. “As long as you keep improving, you’re just tickled to death. Once it plateaus, then you want more.”
While James Parsons was impressed with Landewee’s progress, he was beginning to realize that making his own decision would not be easy. “The hard thing is you do as much research as you can online, but unless you actually go and meet each person that’s been through it and actually see video of the before and after, and follow up with them for a couple of months, it’s hard to know,” he says. “Even another T6 para has different sensation levels and feelings, and a huge gain to me might not be a huge gain to someone else, so it’s really hard to gather objective information.”
Faced with a wait list of more than one year, James decided to secure a spot just to keep his options open, so he arranged to have a current MRI and a motor, touch, and pinprick test score sent to Xi Shan Hospital.
While Roger Parsons was favorably impressed with what he saw at Xi Shan Hospital, Aaron Dempsey’s initial experience there sounds like a nightmare of culture shock: “I thought we had the wrong place when we arrived,” he says. “I’d never been out of the U.S., I had expectations of certain levels of comfort, and they had absolutely none of that. It looked like a rundown hospital. I was a little disappointed. After the first few days, I almost turned around and came back home.” But the Dempseys stayed, and Aaron was operated on a week later.
“Just before the surgery, I was scared to death,” he says. “I couldn’t understand what they were saying and they couldn’t understand what I was saying. I was trying to ask the doctors what the procedure would be like, and they would just look at me with a blank stare and that’s when I started freaking out.” The next thing he knew he was waking up in his room. “My neck hurt so bad — it was worse than after my accident. Then after a few days, the soreness went away and the only thing that hurt was my shoulders. Apparently they leaned me over something to work on my neck. I was wrapped around this thing for about six hours, and that really tore my shoulders up.”
After a week, Dempsey began to notice changes. “I could feel more when someone would touch me, and I was sweating a lot more. I thought it was a great sign. And I was able to move my leg a lot better [he could move his right leg slightly before the procedure].
Like many others with SCI treated by Huang, Dempsey noticed sensory improvement most of all. “Before, I could feel my right side but nothing on the front of me. I could now feel my stomach on the right side of my body, and I couldn’t feel there before. The left side was still more or less numb, but I could feel it just a little better.”
Areas of new sensation, he says, improved daily and then plateaued about three weeks post-surgery. “From what Huang had said, I was expecting that it would take a lot longer. But it reached a point where it didn’t do any more while I was still there.” He says there has been no change in his bowels and bladder, but he has slight improvement in internal sensation.
The Dempseys went directly to RIM in Detroit for intensive therapy when they returned to the States. “I stood up on a walker for the first time and used a gait trainer, suspended on a treadmill. It really felt good. I got a lot stronger while I was there, but unfortunately we ran out of money and had to come home. My stomach got stronger and also my legs. I think the therapy is probably the most important thing.”
Would he do it again?
“I probably would. I didn’t lose anything from going over there. All I could do would be to gain from it.”
More Controversial Procedures
James Parsons secured a surgery date — Sept. 18, 2006 — at Xi Shan Hospital, but prior to that date he and his father wanted to talk to two experts, Wise Young and Steven Hinderer, director of the SCI Recovery program at RIM. Young, because he was on sabbatical at Hong Kong University, proved difficult to contact. In the meantime, James and his father regularly trolled the CareCure website in search of other “cure” stories.
Websites outside the CureCare community advertise more controversial procedures than Huang’s. One — www.stemcellschina — includes personal testimonials but no objective verification. One of the more dramatic stories involves David Aldrich, 50, who traveled to Shenzhing, China to undergo umbilical cord blood cell injections overseen by Dr. Sean Hu, founder of Beike Biotechnology, a multinational company offering treatments at several hospitals.
Aldrich, from Delray Beach, Fla., had sustained a C3-4 incomplete SCI when he fell from a boat in shallow water on May 27, 2002 and, in his own words, “drowned.” Brain damage from hypoxia resulted in near total blindness and deafness. “I spent a total of 359 days in hospitals,” he says, still speaking with difficulty. He was finally discharged from Craig Hospital, having arrived weighing a meager 120 pounds, half his pre-injury body weight. He still had severe vision and hearing problems in addition to incomplete quadriplegia.
After leaving Craig, Aldrich’s motor ability improved slowly over the next three years. Effects from his brain injury also diminished, but by the time he went to Shenzhing, his vision was still blurry, he could not read and hearing was difficult. He had limited movement in his arms, no movement in his hands, he could move his left leg slightly, and had “a twitch” in his right leg but no real muscle control.
On August 28, 2006 Aldrich flew to Shenzhing, where he received four injections by lumbar puncture and two intravenous infusions. He says each injection consisted of “10 million stem cells.” Concurrently he began a daily regimen of massage, acupuncture and physical therapy and was placed erect on a tilt table for the first time since his injury. “As I was there I started to develop more movement in my left leg and increased strength in my right. And I could wiggle my toes and move my feet. I’d never experienced this until after the stem cell injections,” he says.
As significant as these gains sound, what pleased Aldrich most was the marked improvement in his vision. Within days he began to read large print for the first time since his accident. When he returned to his home in Florida, he began aquatherapy and says at first he needed assistance to walk across a 12-foot wide pool filled with 4.5 feet of water. A year later, he claims, he could make the same trip unassisted in 3 feet of water.
In a progress report available on his website, he writes in bold print: “I feel that my results so far are absolute proof of the power of stem cell therapy!” Aldrich paid about $20,000 for his treatment and was preparing to return to Shenzhing for a second series of injections in January.
James Parsons had been an excellent golfer before his accident, even winning the junior title at Portland’s Riverside Country Club in 1997. In spring of 2005, he had tried golfing from a sitting position for the first time. “That was the first time that I realized in a big way that I can no longer do what I used to do,” he says. During the summer of 2006, at a Mobility Impaired Golfer’s Association fundraising event, James discovered something that turned disappointment to hope for a moment.
An adaptive golfing device elevated James upright, where he was able to swing a club from a standing position for the first time since his injury. With his father watching proudly, both of them realized that he might be able to recapture more of his former ability than he had thought. But as many former athletes with SCI have discovered before James, the moment, while uplifting, was also a reminder of what no piece of adaptive equipment, no matter how sophisticated, can restore. “That’s why they call it adaptive equipment,” he says.
Amanda Boxtel also excelled at a sport — skiing — before being injured on the slopes February 27, 1992. Boxtel, 40, a T11-12 complete para for more than 15 years, began reaching out to friends and residents in upscale Aspen, Colo., in 2007 after her mother had clipped an article about a “miraculous cure” and sent it to her. She had decided to raise $30,000 to go to India for a controversial restorative therapy. In a message posted on Snowmass.com, Boxtel pleaded: “We need your help. Does anyone have a connection to Oprah? Please spread this e-mail. The world needs to be alerted of Dr. Geeta Shroff’s ground-breaking treatment and her amazing accomplishments.”
Boxtel, who had considerable experience raising funds as co-founder of Challenge Aspen, an adaptive winter sports program, gathered her personal funding and flew to Delhi, India in late June 2007 to undergo what she calls the “only pure human embryonic stem cell” treatment in the world. But Dr. Shroff’s secretive procedure is dismissed by many scientists. She has not shared information with the scientific community and is securing a patent.
None of this matters to Boxtel, who is unabashedly enthusiastic about Shroff’s treatment. “This woman is, I believe, deserving of the Nobel Peace Prize,” she says, “and people want to shoot her down. I believe that I’ve been injected with the most intelligent God-given chip in the world. And it’s pure. Nothing, nothing can replace the pure embryonic stem cell.”
Boxtel claims to have received, over a period of eight weeks, twice daily intramuscular injections of embryonic stem cells, plus twice weekly intravenous treatments. She says the embryonic stem cells were pre-differentiated into neuronal stem cells that have the ability to “home” into the damaged area of the spinal cord. She also says she had two or three treatments in which frozen syringefuls of 50 million stem cells each were injected into the dura of the spinal cord, and another procedure involving a 5-inch catheter in which “the outer sheath of the spinal cord was completely saturated and flooded with stem cells.”
And the results?
Pinning down objective specifics is difficult, partly due to Boxtel’s missionary zeal. Eager to share her experience — although not an invited speaker — she traveled to the Harvard Stem Cell Summit in October 2007. “I got up and spoke in front of about 700 people,” she says, “and you could have heard a pin drop as I shared my story and the fact that my bladder’s coming back, I can void on my own, I’ve got glutes, quads, hamstrings and toes on both feet that wiggle.”
But after a second impromptu speech in the lobby, with media cameras filming, her testimony was effectively censored, she says. “I was told when I wanted to get the footage that a certain individual had ordered them to destroy my footage. And those are powerful words — ordered to destroy Amanda Boxtel’s footage.”
Boxtel is still a para, still dependent on her wheelchair, but says she can now bend her knees while lying on her side. She also says her sensory awareness is very strong now in her pelvic area: “I’ve got amazing sensations that are coming back, that are restored, that I haven’t felt in my sexual body for 16 years.” She also says she is mostly free of burning nerve pain that was a chronic problem before.
Boxtel’s enthusiasm, ironically, invites skepticism: “This is a cure-all for all of humanity,” she says. In a Sept. 8, 2007 document posted on her website, she ticks off a list of illnesses and disabilities that she says Shroff has treated successfully (more than 300 people in all), with no adverse effects (but no peer-reviewed studies): SCI, Parkinson’s, stroke/Alzheimers, motor neuron disease/ALS, diabetes, blindness, CP, autism, heart conditions, traumatic brain injuries, and cancer. “I am compelled to share my experiences with the world,” she writes.
Boxtel returned to India for a second round of injections in January and says she expects to have four to six additional treatments over the next two years.
With a Sept. 18 surgery looming, James Parsons and his father finally communicated with both Dr. Hinderer and Dr. Wise Young. In an e-mail dated July 11, 2006, Young wrote to Roger Parsons and explained that Huang’s therapy “is producing relatively variable and modest motor return, although it does seem to produce more consistent sensory return of four or more dermatomes [vertebral levels]. In my opinion,” wrote Young, “there will be better treatments that are going into clinical trial in the next year or two.”
In a conference call just days later, Dr. Hinderer more or less concurred with Young. In early fall, Roger was able to meet with Young for lunch in Hong Kong. They talked for three hours.
The Parsons’ research was now complete.
“What it boiled down to,” says James, “was if I had been a lot worse off or had a lot higher injury, or wasn’t able to function very independently, then I would have either done it or thought about it a lot more seriously. But the best that I could imagine for me would be if I got a couple of levels back and became a T8 or T9 — but I already kind of feel at that level.”
Another factor in James’ decision was the influence of intensive therapy following surgery. “My father and I both started thinking, is it really the surgery, or is it maybe the first time — or maybe a long time — since these people put forth a lot of effort in an intensive therapy environment?”
And finally, James considered the possibility that going ahead with a procedure now might eliminate him from future clinical trials that would promise more later. “If a trial does come to the United States, which — God almighty, I hope it does — they would probably want to take people who haven’t had this surgery to really get a true test.”
Instead of going to China, James used his vacation time from work and went to RIM in Detroit for three weeks of intensive therapy. Was it worth it? “Absolutely,” he says. “I learned a lot about what I’m able to do independently to strengthen my core muscles and learned new exercises.” He now owns two new pieces of exercise equipment that are routinely used at RIM — an EasyStand Evolv Glider and a Panasonic Core Machine — and works out regularly at a local Bally’s.
“For me, going to RIM was a big gain in itself — without having to take the risk that comes with surgery. And by waiting now and staying in shape, I increased my chances of a more substantial gain later. I wanted more.”
What Does it Mean?
Olfactory ensheathing glial cells (OEG or OEC): Origin: The olfactory bulb in the brain of the person to be treated or an aborted fetus. OEG have been shown to stimulate nerve axon regeneration and myelination in animals, and are differentiated fetal cells, not stem cells.
Umbilical cord blood cells (UCB cells): Origin: placentas and detached umbilical cords of newborns. UCB cells are fetal stem cells that are currently used to treat blood diseases. They may or may not be useful as a treatment for spinal cord injury
Human embryonic stem cells (hESC): Taken from the blastocyst stage of embryonic development, hESC have the ability to differentiate into different cell types, such as neuronal cells.