Thursday, May 26, 2005

ProCord Trial for Complete Spinal Cord Injury Now Live at Shepherd Center in Atlanta

Shepherd Center announced yesterday that it is now a treatment site for Proneuron's Phase II, multi-center, randomized-controlled trial of ProCord for complete spinal cord injury. Shepherd Center has been enrolling patients in the study as an IRB patient referral and follow up site for more than a year. With the completion of the establishment and operation of a specially designed cell processing center at Cell Design LLC in Atlanta, Shepherd Center has the necessary tools to implement the surgical segment of the experimental therapy.

"The ProCord trial continues and is currently live at Shepherd Center. We are now fully equipped to provide both the surgical and the post-operative rehabilitation portions of this experimental treatment. We look forward to continuing our participation in this very important research," said David Apple, Jr., MD, Emeritus Medical Director of Shepherd Center.

The Marcus Foundation provided the $3.2 million in financing used to build the ProCord processing cell center at Cell Design and to begin the implementation of the study at Shepherd Center.

"We are proud to be an active part of this worthy initiative and are hopeful that this enormous effort will result in the improvement of the well being of patients," said Dr. Robert McNally, President of Cell Design LLC.

Dr. David Snyder, V.P. of Clinical Development at Proneuron commented, "Timing is a crucial element in this study, from the admission of patients through the implantation of the autologous cellular product. It is important to remember that qualifying patients must be enrolled within 12 days of their injury in order to receive ProCord within the 14-day study protocol window."

Patient, Immediate Family of Patient and/or Physician inquiries:
24 hour a day Patient Recruitment Center:
Email: clinical.trial@proneuron.com
Telephone: 1-866-539-0767 (U.S. toll free) or 1-506-652-3486.
Fax: 1-866-214-7078

Callers outside of the U.S., please use standard
international dialing code.

For complete details about the study: www.spinalcordtrial.com.

Shepherd Center in Atlanta is the country's largest catastrophic care hospital specializing in the treatment of people with spinal cord injury and disease, acquired brain injury, multiple sclerosis and other neuromuscular disorders and urological problems. Shepherd Center is the largest Model Center for spinal cord injury in the country, serves as one of the largest brain injury programs in Georgia, and is an official Multiple Sclerosis Center, designated the National Multiple Sclerosis Society--Georgia Chapter. Founded in 1975, the 100-bed not-for-profit hospital offers a continuum of health care services, from intensive care through inpatient medical surgical care, rehabilitation, day program, and outpatient and residential services.
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Tuesday, May 24, 2005

South Koreans Report Major Development in Stem-Cell Research

South Korean scientists reported Thursday that they've generated the first human embryonic stem-cell lines carrying genes that match the DNA of patients suffering from disease or spinal-cord injury.

The development, described in a paper published online Thursday by the journal Science, represents a major step in the field of stem-cell research. The immediate impact is that researchers could soon study cells carrying specific variations of disease in the laboratory.

Eventually, scientists hope that the same technology will allow the generation of healthy cells that can be transplanted into patients to replace cells damaged by disease or injury.

"What the study shows is that stem cells can be made that are specific to patients regardless of age or sex, and that these cells are identical genetic matches to the donor," said Dr. Gerald Schatten, vice chairman of research development in the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh. He helped the Korean team analyze and prepare an English-language manuscript of the findings.

"If they can be safely used in transplant, the promise for effective treatment _ perhaps even cure _ of devastating diseases and injuries comes within reach," Schatten said.

The same researchers reported last year that they had successfully cloned a human embryo to produce an embryonic stem-cell line, setting off a new round of calls for international controls or bans on cloning, although the scientists say they have no intention of cloning to produce a baby, stressing that all evidence indicates that the cells would result in serious abnormalities.

The embryos they used were allowed to develop for only six days, long enough to derive the stem cells that are thought to be able to differentiate to form any type of cell found in the body.

News of their latest accomplishment comes as Congress considers relaxing federal limits on government funding to support embryonic stem-cell research, a move strongly opposed by many groups on moral and religious grounds because fertilized eggs are destroyed in the process.

The team, led by Woo Suk Hwang, a veterinary professor at Seoul National University, collected eggs from 18 unpaid volunteers and removed the nucleus containing genetic material from each of them. Then they inserted DNA derived from skin cells of 11 patients, nine of them suffering from spinal-cord injury, and one each with type 1 diabetes or a congenital immune disease.

The researchers were able to grow 31 early-stage embryos from this process, and from those, harvested 11 different stem-cell lines, each a genetic match to one of the skin-cell donors.

While the researchers in their first cloning experiment had to use 242 donated eggs to produce just one stem-cell batch, in the new effort, an average of 17 eggs were required for each line of stem cells.

The patients donating skin cells ranged in age from 10 to 56, and their age or gender did not seem to make a difference in the ease of producing stem cells. However, the researchers found they had more success with eggs donated by women younger than 30. Most stem-cell lines, including those approved for research in the United States, have not been developed through such direct donations, but from eggs harvested from women who were undergoing fertility treatment and then donated them for research.

The researchers are now doing more testing on the stem-cell lines to determine whether they could be tolerated by patients' immune systems and if they could be guided to develop into the kind of cells needed to treat injury or illness.

They are testing some of the lines in animals with spinal-cord injuries, but Hwang said they are some years away from considering doing any transplants into people. "We have to be overconvinced" that the cells are safe, he said.

Breakout material

South Korean researchers report they've used cloning techniques to create the first human embryonic stem-cell lines specifically tailored to match the genes of people suffering from injury or illness.

"What the study shows is that stem cells can be made that are specific to patients regardless of age or sex, and that these cells are identical genetic matches to the donor." _ Dr. Gerald Schatten, a researcher at the University of Pittsburgh.

By: LEE BOWMAN (Scripps Howard News Service)
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Saturday, May 14, 2005

Breathing Easier After Spinal Cord Injuries

Common tranquilizer may save lives

Injuries to the upper spinal cord can take a victim's breath away.

Most people don't know that breathing difficulties are the leading cause of disease and death after such injuries. Indeed, respiratory failure causes more deaths than limb paralysis does, and survivors often become dependent on ventilation machines.

For the first time, Harvard researchers successfully tested an inexpensive, readily available class of drugs that has restored normalcy to rats who suffered the same loss of breath as humans who receive spinal cord injuries in combat, falls, car wrecks, or by gun or knife. These drugs include buspirone, a tranquilizer used to ease anxiety in the elderly and to help people quit smoking.

"This is the first experiment to demonstrate the complete recovery of respiratory function in conscious rats with injuries in the cervical [upper] region of the spinal cord," says Yang "Ted" Teng, assistant professor of surgery at Harvard Medical School and director of spinal cord injury research at the Veterans Administration Boston Healthcare System. "In light of their availability, we believe drugs such as buspirone offer a novel strategy for treating post-spinal-cord-injury respiratory dysfunction. Also, our work will allow further investigation of other promising drug therapies for this highly morbid and sometimes fatal complication."

Teng also believes that further exploration of the restorative action of drugs, along with use of neural stem cells, could lead to new treatment for breathing complications that arise from other disorders like stroke and Lou Gehrig's disease, also known as amyotrophic lateral sclerosis (ALS).

Breathing easy

Teng and his team dealt specifically with injuries in the cervical region, the upper part of the spinal cord in the neck area, where damage produces the most serious types of breathing problems. An injury in this area left actor Christopher Reeve a quadriplegic and put him on a ventilator.

Most affected is the phrenic nerve that carries impulses to and from the diaphragm. Attached to the spine, the diaphragm muscles draw air into the lungs and push carbon dioxide out. When these nerves don't operate properly, breathing becomes shallow and rapid. The lack of oxygen can also lead to cramps, chest pains, dizziness, confusion, unconsciousness, and, sometimes, death.

Teng worked closely with Howard Choi, a postdoctoral fellow and a physician. They wanted to develop a nonsurgical way to restore function in the damaged nerves. With the help of colleagues from Harvard-affiliated research hospitals, Teng and Choi looked at a group of buspirone-like drugs recently shown to counteract breathing problems produced by lack of oxygen, morphine overdose, and sleep apnea. In the latter, respiratory nerve problems lead to temporary stoppage of breathing, a suffocating experience that prevents a good night's sleep at best and is life threatening at worst. The drugs relieved this condition, providing "a nice hint that they may work in spinal cord injuries," says Teng.

A few years ago, Teng and some colleagues from Georgetown University in Washington, D.C., tried the drugs on rats with injuries in the thoracic part of the spine, below the cervical sections. They worked successfully, but spinal cord injuries to the thoracic segments are far less frequent that those of the cervical segments.

Teng, Choi, and their collaborators designed an experiment with rats that would simulate as far as possible profound human breathing dysfunction. After carefully measuring the normal breathing of the animals, then surgically injuring them, the drugs were injected into their abdomens.

The experimental results were announced in the May 4 issue of the Journal of Neuroscience by the team, which includes researchers from Children's Hospital Boston, Brigham and Women's Hospital, Spaulding Rehabilitation Hospital, and the Veterans Administration Boston Healthcare System. "The majority of the animals recovered to their pre-injury states," Teng sums up the report. "They can breathe without help and feed themselves. Some of them did not receive the injections until two weeks after their injury, and their breathing was restored to normal. That's very encouraging."

Humans are next

To the obvious question of when these drugs will be tested in humans, Teng answers, "as soon as possible. Some of the drugs, like buspirone, have already been approved for other uses and are readily available. So we've begun planning and seeking funds for humans trials."

Two of the questions to be answered by such tests are the proper dosages, which probably won't be the same as for reducing anxiety or apnea, and whether or not people tolerate the dosages as well as rats do.

Previously, Teng led another team that used an antibiotic called minocycline to restore movements in rats paralyzed by thoracic spine damage. In such traumas, tissues continue to discharge toxic chemicals that may kill and disable nerves for days and weeks after the original injury. The hind limbs of rats that didn't receive the drug remained paralyzed while those that did were able to stand on their hind legs and to walk again.

"We would like to do experiments that combine the two drug types," Teng says. Minocycline might provide immediate protection of endangered nerves, while the buspirone-type medications would stimulate function in the spared nerves. These combinations, he points out, may be effective in a wide variety of diseases that affect movement including strokes, Lou Gehrig's disease, multiple sclerosis, cerebral palsy, and Parkinson's.

Teng and his colleagues also see a potential for such combinations in emergency situations where protection and stimulation of nerve function could be started in a matter of minutes. Combat medics in Iraq or Afghanistan, or emergency medical technicians in Boston or Los Angeles might be trained to begin such treatments before the secondary damage becomes disabling or lethal.

What about reversing paralyses, giving paraplegics and quadriplegics the ability to use their arms and legs again? "In these cases, you are not just protecting nerves from further damage or restoring their function, you must reconstitute them, rebuild them," Teng explains. That might be possible someday with the aid of neural stem cells, which can, with the help of growth factors and other emerging tools, regenerate nerves that have been destroyed.

"That task is daunting; it's the ultimate challenge."

By William J. Cromie - Harvard News Office
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Thursday, May 12, 2005

Stem Cell Treatment Improves Mobility After Spinal Cord Injury

A treatment derived from human embryonic stem cells improves mobility in rats with spinal cord injuries, providing the first physical evidence that the therapeutic use of these cells can help restore motor skills lost from acute spinal cord tissue damage.

Hans Keirstead and his colleagues in the Reeve-Irvine Research Center at UC Irvine have found that a human embryonic stem cell-derived treatment they developed was successful in restoring the insulation tissue for neurons in rats treated seven days after the initial injury, which led to a recovery of motor skills. But the same treatment did not work on rats that had been injured for 10 months. The findings point to the potential of using stem cell-derived therapies for treatment of spinal cord damage in humans during the very early stages of the injury. The study appears in the May 11 issue of The Journal of Neuroscience.

"We're very excited with these results. They underscore the great potential that stem cells have for treating human disease and injury," Keirstead said. "This study suggests one approach to treating people who've just suffered spinal cord injury, although there is still much work to do before we can engage in human clinical tests."

Acute spinal cord damage occurs during the first few weeks of the injury. In turn, the chronic period begins after a few months. It is anticipated that the stem cell treatment in humans will occur during spinal stabilization at the acute phase, when rods and ties are placed in the spinal column to restabilize it after injury. Currently, drug treatments are given during the acute phase to help stabilize the injury site, but they provide only a very mild benefit, and they do not foster regeneration of insulation tissue.

For the study, the UCI team used a novel technique they created to entice human embryonic stem cells to differentiate into early-stage oligodendrocyte cells. Oligodendrocytes are the building blocks of myelin, the biological insulation for nerve fibers that is critical for maintenance of electrical conduction in the central nervous system. When myelin is stripped away through disease or injury, sensory and motor deficiencies result and, in some cases, paralysis can occur.

The researchers injected these cells into rats that had experienced a partial injury to the spinal cord that impairs walking ability -- one group seven days after injury and another 10 months after injury. In both groups, the early-stage cells formed into full-grown oligodendrocyte cells and migrated to appropriate neuronal sites within the spinal cord.

In the rats treated seven days after the injury, myelin tissue formed as the oligodendrocyte cells wrapped around damaged neurons in the spinal cord. Within two months, these rats began to show significant improvements in walking ability in comparison to injured rats who received no treatment.

In the rats with 10-month-old injuries, though, motor skills did not return. Although the oligodendrocyte cells survived in the chronic injury sites, they could not form myelin because the space surrounding neuron cells had been filled with scar tissue. In the presence of a scar, myelin could not grow.

These studies indicate the importance of myelin loss in spinal cord injury, and illustrate one approach to treating myelin loss. Keirstead and his colleagues are currently working on other approaches using human embryonic stem cells to treat chronic injuries and other disorders of the central nervous system.

In previous studies, Keirstead and colleagues identified how the body's immune system attacks and destroys myelin during spinal cord injury or disease states. They also have shown that when treated with antibodies to block immune system response, myelin is capable of regenerating, which ultimately restores sensory and motor activity.
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Tuesday, May 10, 2005

Spinal Cord Injury Research Event

A conference on spinal cord research featuring national experts on science, ethical and political issues will be held May 21 in Ypsilanti, Michigan.

The conference is sponsored by the University of Michigan, the Ann Arbor Center for Independent Living and the Michigan Paralyzed Veterans of America. It begins at 9 a.m. at the Marriott Hotel in Ypsilanti.

To register online, visit www.med.umich.edu/ pmr/modelsci/ spring conference.htm.

The cost is $75 for physicians, $60 for medical professionals, $25 for families dealing with spinal cord injuries and $10 for others. It includes breakfast and lunch.

For more information about the conference and registration, call 734-763-0971 anytime.
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Small Steps Toward Goal: Gain Through Pain

Walking and standing after surgery brings independence

BY PATRICIA ANSTETT - FREE PRESS MEDICAL WRITER

With the help of three therapists and new high-tech leg braces developed in Michigan, Cortney Hoffman took her first steps last week since her spinal cord injury in a 2002 auto accident.

Cortney, 18, of Temperance, north of Toledo, is building her upper-body strength and muscle tone and can move herself from her wheelchair to her bed.

Her dream is to walk again, but she appreciates every gain short of that. Like so many others with spinal cord injuries, the independence she is regaining is at least as, if not more, important than walking.

Cortney has surpassed her first goal -- standing unassisted -- since she went to Portugal in January for adult stem-cell surgery to repair her injured spinal cord. The success of the experimental surgery, which has attracted interest worldwide, is dependent on at least two years of aggressive physical therapy.

There remain plenty of questions and skepticism, among both patients and experts in the field, including: Is the aggressive therapy or the surgery responsible for patient gains? How long do benefits last? Have patients been hurt by the surgery?

There are other issues. There still are no published studies. The surgery costs $47,500 for the operation, hospital expenses and trip to Portugal, and many insurance plans do not cover it. Cortney's no-fault auto insurance did.

Yet, with an estimated 247,000 Americans living with spinal cord injuries at a cost to the United States of $9.73 billion a year according to a recent report from the Institute of Medicine, interest is keen, both in the spinal cord community and the media.

Tonight, "CBS Evening News" is scheduled to show a report on Cortney at 7 p.m. Cortney tells those who ask about the operation and grueling therapy, "It's worth it." And her doctors, too, are pleased with her progress.

Making progress

Dr. Owen Perlman, a Superior Township rehabilitation medicine specialist and Cortney's primary physician, concluded on Cortney's last appointment April 21 that she has made gains he would not have expected if she had not had the surgery. He hadn't seen those gains in the aggressive rehabilitation she underwent for several months before the surgery.

Perlman called her progress "very slow" at the April appointment but praised her gains.

"She is working very hard. We have eight doctors in this practice, and we all feel pretty good about the surgery," he said.

"Time will tell. Based on my understanding of the surgery and how people are recovering, there's potential for greater progress in the months ahead; the proof will be at six, 12, 18 and 24 months after surgery," Perlman said.

Perlman is not associated with the spinal cord team at Detroit's Rehabilitation Institute of Michigan, which has a formal relationship with Lisbon's Hospital de Egas Moniz to screen patients for the operation and provide the rehabilitation needed afterward.

Fifty-two people, mostly Americans, have had the operation since the Lisbon hospital began performing the procedure in July 2001, according to e-mail correspondence last week with Dr. Carlos Lima, the neuropathologist and spokesman for the team.

Both Lima and Dr. Steven Hinderer, specialist-in-chief for physical medicine and rehabilitation at the institute, hope to publish research this year.

Though no surgery patient has yet achieved walking with ease, one is walking unassisted without braces; some can swing their legs; and a few have regained some bladder control, according to Lima. The rest all are showing gains in function, sensation and strength. There have been no deaths or permanent loss of function, he said. Two had temporary loss of sensation in one limb and two developed a type of meningitis infection, but they have recovered, he said.

Nearly all patients temporarily lose their sense of smell and taste. Cortney lost both, though each returned in three months.

Interest in surgery growing

The Lisbon team calls the operation an autologous spinal cord autograft. Autologous procedures are those using a person's own cells, tissue or organs. In this case, it's tissue from the olfactory bulb, obtained with a thin tube inserted into one or both nostrils to an area high up in the nasal cavity. The tissue is transplanted into the spinal cord injury site, after the site is cleared of scar tissue that forms after an injury.

The hope is that these transplanted cells will form new nerve cells and neural connections between the spinal cord and brain, a sophisticated rewiring feat.

The Rehabilitation Institute is conducting stem-cell research on animals with damaged spinal cords and charting outcomes on surgery patients undergoing rehabilitation there. The institute hopes to do the procedure someday in Detroit.

The Lisbon doctors recently trained teams in Panama and Columbia to do the procedure.

So far, all 44 patients screened in Detroit and who have undergone the Lisbon operation have shown improvement, Hinderer said. It is affiliated with the Detroit Medical Center and the Wayne State University School of Medicine. The institute has followed the patients for at least a month, and some for as long as two years.

All have some "return of sensation and voluntary muscle function," Hinderer said.

Though none are walking without braces, many can walk on their own in leg braces, holding on to parallel bars, walking devices or other people. Many now can feed themselves; some can move from a seated to standing position and several have improved bladder and bowel function, requiring less care from others, Hinderer said.

"At some point they will plateau, but I don't expect that for another year or more," he said.

Not all the patients share a goal of eventually walking. Becoming more independent is more important to many of them, Hinderer said. In the meantime, hundreds of patients are applying to the Rehabilitation Institute for the surgery. The institute has screened 57 patients to date, most since last July.

Thirteen more patients screened in Detroit are scheduled to travel to Lisbon for the surgery this year, and 42 others await word about qualifying for surgery, according to John Elliott, director of physician services at the institute.

Candidates for the Portuguese procedure are people with a spinal cord injury less than 6 years old and who are younger than 40. The age limit was set by the Lisbon team because nerve cells from the olfactory bulb change in function as people age, from cells used in smelling to ones that help with breathing.

By next year, the institute hopes to get approval from the U.S. Food and Drug Administration to begin a study of the procedure in the United States. But first it must present compelling results from animal studies that show the surgeries would pose no risk to people and are likely to be beneficial.

Federal health authorities also want published studies that follow the outcomes of patients undergoing stem cell surgery.

Finding independence

Just like a baby, attempting and achieving movements like standing and walking after a spinal cord injury takes time. The rigorous therapy takes commitment, and some aren't up to it.

Cortney is.

Always trying, often smiling, she makes the one-hour drive from her home to Detroit three times a week for three hours of rehab. The institute charges $1,400 to $4,000 a month, depending on the number of weekly visits. Insurance coverage varies. In Michigan, neither the Medicaid nor Medicare program pay for the rehabilitation.

Cortney's new goal is to walk in her braces. She's also learning to drive again, in a car operated by hand controls. Taking just a few steps with help last week thrilled her.

"This is how it starts," said Bill Thornton, a physical therapist at the institute. "Each day, a little more. Each time she stands, each time she takes a step, it will get a little easier."

Cortney nodded in agreement.

"I know it's going to take hard work and time. I expect smaller gains first. After that, who knows?"

She will give herself a day off and be back for more.
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Sunday, May 01, 2005

Bulgaria: the latest country to join spinal cord revolution

Bulgaria has become the latest country to successfully use adult stem cells in treating spinal cord injury. Scientists based at the Alexandrovska Hospital harvested adult stem cells from the pelvis and chest bones of quadriplegic patient Dimitar Tchobanov. The cells were then implanted back into his spine.

Dimitar Tchobanov, who was rendered paralysed after a car crash in 2002 is now showing signs of improvement. The news means that Bulgaria joins Russia, Korea and Portugal in using adult stem cells to treat patients with spinal cord injury.
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