Wednesday, December 24, 2003

Bases for Hope in Spinal Cord Injury

The most recent lecture by Wise Young summarizing the progress in spinal cord injury care and research since 1995, all the current clinical trials, and therapies that are being considered for clinical trial. You can also download a pdf file containing the slides and notes of the lecture.
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Thursday, December 18, 2003

Proneuron BioTechnologies

Proneuron Biotechnologies Teams with Craig Hospital in Denver to Expand IND Phase II Trial of ProCord for the Treatment of Spinal Cord Injuries to the U.S.

Los Angeles, CA and Denver, CO, December 8, 2003

Proneuron Biotechnologies, Inc. (www.proneuron.com), and Craig Hospital (www.craighospital.org) announced today that enrollment in Proneuron's IND Phase II trial of ProCord is now open to patients at Craig Hospital in Denver, Colorado. Proneuron is a leader in the development of treatments for patients with spinal cord injuries and other acute and chronic disorders of the central nervous system (CNS). Proneuron's processing Cell Center at Craig is the first U.S. site that will test ProCord, which consists of autologous activated macrophage therapy for a randomized controlled trial for patients with acute complete spinal cord injury (SCI) within 14 days of injury.

The trial commenced at Sheba Medical Center in Tel Hashomer, Israel, in September 2003. Following the necessary approvals, three additional sites located in the US will also study this experimental procedure including: the Mount Sinai Medical Center in NYC; Kessler Institute for Rehabilitation in West Orange, NJ and Shepherd Center in Atlanta, GA. This is the first step in implementing Proneuron‚??s test of ProCord at multiple geographic clinical sites in their goal to commercialize operations in North America.

Daniel P. Lammertse, M.D., Medical Director of Craig Hospital and immediate past president of American Spinal Injury Association, expressed optimism for the potential of this treatment: "The Phase I trial suggests a positive treatment effect, giving clinicians hope that this may prove to be a helpful treatment in improving the outcomes of patients with spinal cord injury".

Following tissue injury, a type of white blood cell, called a macrophage, quickly starts to remove cell debris. These macrophages then start to secrete growth factors that promote a controlled inflammatory reaction to initiate the wound healing process. While this process occurs effectively in most tissues including peripheral nerves, it does not occur effectively in the CNS. Discoveries led by Prof. Michal Schwartz of the Weizmann Institute of Science have shown in pre-clinical studies that specially treated macrophages, however, promoted recovery from spinal cord injury (SCI). Based on these findings, Proneuron is now developing ProCord as a clinical product to treat patients with spinal cord injury. ProCord consists of macrophages isolated from the patient‚??s own blood, activated through a proprietary process and then injected directly into the patient‚??s injured spinal cord. It is crucial that the investigators are notified of a potential candidate within a few days of their spinal cord injury in order to give ample time for patients to enroll and participate in the 14-day window of the clinical trial.

"We are honored to collaborate with Craig Hospital, one of the top treatment centers in the world for spinal cord injury. We have established a working relationship together in the follow-up rehabilitation of some of the patients who participated in the Phase I trial. It is our hope that our newly established ability to offer our experimental treatment to patients in the U.S. will help us to better serve the patient population in the Americas," said Proneuron's V.P. of Clinical Development Dr. David Snyder.
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Tuesday, December 16, 2003

Christopher Reeve Paralysis Foundation - Take Action Now

"Don't Ban Hope"
Ban Human Reproductive Cloning BUT Not Therapeutic Cloning

Recent research in the area of somatic cell nuclear transfer (SCNT), also known as therapeutic cloning, has shown that a patient's own genetic material could be used to develop stem cell therapies specifically tailored to that individual's medical condition, thus avoiding an immune rejection response.

Your elected officials will soon be deciding whether or not to ban this kind of research altogether, both for human reproductive and for therapeutic purposes. Imposing a ban on SCNT would:

--Jeopardize research vital to helping those with disabling and deadly conditions

--Prohibit the importation of therapies derived from SCNT in other countries

--Criminalize the research or the researchers

Given the strong scientific potential in this area, CAMR firmly opposes any legislative or regulatory action that would ban research related to SCNT for therapeutic reasons. Your voice is needed now! Please write to your elected officials to ensure that this life-saving research be allowed to move forward. It only takes three easy steps.
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Monday, December 15, 2003

Cell Transplants Help to Reverse Paralysis

Patients are feeling a sensation of hope

Robert Smith, 46, of Harrison Township underwent a Chinese procedure to help him regain movement. With him are his daughters Jaimie, 15, left, and Jennifer, 19.

The first American spinal cord patient to undergo a fetal cell transplant procedure -- a Harrison Township man paralyzed in a Lake St. Clair diving accident -- is regaining some movement and sensation a month after the experimental operation in China.

"I have normal sensation in parts of my body that I haven't felt in four years," said Robert Smith, 46, a one-time Chevy car salesman paralyzed from the chest down on July 4, 1999, when he dove off his boat into water that was more shallow than he thought.

He spoke at a news conference at the Rehabilitation Institute of Michigan's Novi facility Thursday.

Last month, Smith and two other Americans from New York and South Dakota went to Beijing for an experimental technique called olfactory ensheathing glia cell transplant.

It takes cells from the olfactory nerve above the ridge of the nose and injects them above and below a person's injury site. The olfactory cells are some of the only nerve cells in the body capable of continually regenerating themselves. They help coat, or ensheath, myelin that covers nerve cells, hence the name.

Dr. Hongyun Huang, the Chinese neurosurgeon who developed the technique, uses more than 1 million cells from aborted fetuses for each transplant.

A related procedure developed by Dr. Carlos Lima, a Portuguese physician, uses a person's own olfactory cells, obtained by threading a tube up the nose to extract them, then packing those cells above and below the injury site. It is known as the Lima procedure, or olfactory mucosa tissue transplant. It is much newer and appears to take longer to work.

Erica Nader, 25, whose legs were paralyzed in an auto accident two years ago while visiting her parents in Farmington Hills, was the first American to undergo the Lima procedure, performed in March. She is undergoing intense six-day-a-week rehabilitation, three to six hours a day.

"Everybody seems to be looking for the magic bullet; actually, it's a mix of things," said Nader, a San Diego resident and a California Peace Action worker at the time of her accident. She attended the news conference with her family.

Dr. Steven Hinderer, specialist-in-chief at the Rehabilitation Institute, an affiliate of the Detroit Medical Center and the Wayne State University School of Medicine, said the two procedures show that "it's very clear there's opportunity for substantial, if not full recovery."

The institute is collaborating with physicians in China and Portugal to study the procedures. It also will evaluate U.S. patients who may be eligible for the two procedures overseas and collect data in a computer registry.

At the same time, the institute is creating a new program, different from conventional spinal cord rehabilitation efforts, to be tentatively called the Neurorecovery Center for Spinal Cord Injury, to open in June. It will offer intensive rehabilitation programs focusing on nerve regeneration and sensory nerve stimulation approaches.

Neither olfactory cell procedure is likely to be offered in the United States soon, particularly the Chinese approach because of its controversial use of fetal cells.

Hongyun, a neurosurgeon at the Beijing Chaoyang Hospital, spoke at the news conference to summarize results of more than 300 patients who have undergone the technique in the past three years. He said recovery varies from slight to partial improvements in movement and sensation, including regaining bladder and bowel function, as Smith said he is beginning to do.

The procedure is appropriate for spinal cord patients without a completely severed spinal cord and some other neuromuscular disorders, including multiple sclerosis and Lou Gehrig's disease, Hongyun, said. It takes two hours, costs $20,000 and is not covered by insurance. Hongyun hopes to publish his results soon. For now, most doctors "don't believe what I'm saying," he said.

Complications have been limited to a few patients who developed problems typically associated with surgery, such as infections or leg blood clots.

Smith, a father of three and married 23 years, found out about the Chinese approach on the Internet. Hinderer and another doctor assured him he wasn't foolhardy to pursue the operation. Within hours of the procedure, Smith could wiggle toes he couldn't move before, breathed better and had a stronger lefthand grip, he said.

Smith, too, is undergoing intense rehabilitation, five days a week for six months. Asked how much recovery he expects to achieve, Smith said: "I think the sky's the limit."

BY: PATRICIA ANSTETT, FREE PRESS MEDICAL WRITER
PATRICIA BECK/DFP
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