Denver hospital begins enrollment for Israeli trial for treatment of spinal cord injuries

[Max]

Denver hospital begins enrollment for Israeli trial for treatment of spinal cord injuries
Dec. 08 - Proneuron Biotechnologies, Inc. and Craig Hospital announced that enrollment in Proneuron's IND Phase II trial of ProCord is now open to patients at Craig Hospital in Denver, Colorado. Based in Israel, 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. "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. For 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.
Full article (http://www.israel21c.org/bin/en.jsp?enPage=BlankPage&enDisplay=view&enDispWhat=Zone&enDispWho=InThePress&enZone=InThePress&Date=12/8/03%2011:35%20PM)

(Edited to shorten the URL and make this more readable on screen. KLD)

[This message was edited by SCI-Nurse on 01-04-04 at 08:19 PM.]

[Max]

should be permanent here, since it provides immediate contact info for newly injured members http://sci.rutgers.edu/forum/images/smilies/confused.gif

[Max]

Originally posted by Max:

should be made permanent topic here, since it provides immediate contact info for newly injured members http://sci.rutgers.edu/forum/images/smilies/confused.gif


Seems like NOBODY CARES! http://sci.rutgers.edu/forum/images/smilies/mad.gif
Bump

[This message was edited by Max on 01-08-04 at 02:55 PM.]

[Max]

Promise for the paralyzed
Groundbreaking procedure at Craig Hospital offers hope to those with spinal injuries

By Bill Scanlon, Rocky Mountain News
February 14, 2004

ENGLEWOOD - A skid into a tree, a bad fall on an icy mogul, a fall from a roof - it takes just a second to turn a healthy person into a quadriplegic or paraplegic.

For thousands of years, a severe spinal cord injury meant certain death. For much of the last century, it meant a painful year or two before the grip of death.


Advertisement



For the past 40 years, it has meant life in a wheelchair, with pressure sores, no control of vital organs and no feeling below the point of injury.

But now there is a glimmer of hope that at least partial feeling can be returned to those with spinal cord injuries and that some can rebound enough to have some control over their limbs.

Newly paralyzed people from across the country are making the pilgrimage to Craig Hospital, hoping an exotic new procedure can restore feeling to their toes, feet, arms and legs.

http://rockymountainnews.com/drmn/local/article/0,1299,DRMN_15_2654376,00.html

[Max]

I remember what it was like to have nothing - no feeling '
Rocky Mountain News - Denver,CO,USA
Melissa Holley, the first person in the world to get macrophage injections
for a spinal cord injury, is a believer. "I can't ignore ...
http://rockymountainnews.com/drmn/local/article/0,1299,DRMN_15_2654378,00.html

[JDR]

Max,
I agree...i'm very close to the procedure and am aware of the possible benefits.

[rvr]

YEA!! maybe new sci's can have a better life than us!! wish it was for us, but at least it's a step in the right direction....

rvr

[Little_one]

My brother just recently had a spinal cord injury on 3/15/04 and his doctors are talking to us about doing the procedure on him. The criteria is very strict and out of every 3 people that go only 2 are picked and one doesnt get the surgery, we are currently trying to get my brothers left arm as strong has his right so he can have the surgery. The surgery has to be done within the first 14 days of the accident. So please keep your fingers cross that everything goes good for my brother so he can have this surgery. In a few months New Jersey will be the second hospital in the Country to do this procedure too.

[JDR]

LittleOne...contact me for information on the procedure. I was patient number 15.

[Max]

Originally posted by JDR:

Max,
I agree...i'm very close to the procedure and am aware of the possible benefits.

Thanks JDR!


Aparenly our "honorable" moderartors Nurseyhttp://sci.rutgers.edu/forum/images/smilies/wink.gif & Wiseyhttp://sci.rutgers.edu/forum/images/smilies/wink.gif have different opinion! http://sci.rutgers.edu/forum/images/smilies/eek.gif

[Little_one]

Hey JDR i would like to hear all about your experience and all that, feel free to e-mail me at asweetieforyou247@hotmail.com

[Little_one]

Well, we didnt make it to Craig hospital, today was the final day for the air vack plane to take off, we just cant get rid of his fevers. The doctors call it Central line autoregulation fevers. But in away now, he doesnt meet the critaria, cause for the first time yesterday he could feel someone moving his legs. We got to hear him talk for the first time in a week and he was talking to one of his best friends, when my dad started to rub and message his calf and Loren stops talking and asks my dad are you rubbing my calh muscle? My dad says yes, and Loren said he can feel it. So we were soo happy we started getting teary-eyed and so did my brother. When the PT came in to put him in the cadilac chair he told the two women that his butt was numb and that he can feel pressure when he sits as well as in his back. I told his PT that he has a vibrating sensation in his legs, and when the PT went to go touch his tow she asked Loren if he can feel that and he said yeah you are moving my big toe back and forth, so that made everyone in the room all happy. I think there were 10 of us in his ICU room.(friends and family). He told my dad yesterday when they deleted the balloon from the trachea that he wants to start rehab next week. Everyday he gains more and more feeling and movement, in his arms, back, waist etc. I want to believe so much that all this is a good sign, but everytime we get to feeling good and happy with his progress, the doctors are like dont get your hopes up, just cause he can feel and do things doesnt mean anything yet. All the nurses and PT, OT, RT are happy cause it hasnt been 2 weeks since the accident. I was just sooo glad of all the little things he has accomplished. I kind of liked it when he didnt talk, cause he couldnt tell me what i can and cant eat due to my pregnancy. As soon as they delfeated his balloon, he was telling me in a stern voice no more soda thats my nephew in there, and i said niece. It felt good to tease him about the baby, and he laughed and said i love you and the baby!! I started to cry and so did everyone else. Am i getting my hopes up too soon, with all these feelings and sensations that he has? Thank you for everything and God Bless.

Romans 4:13 I can do all things through Christ who strengthens me!!

[kate]

Originally posted by Little_one:

I want to believe so much that all this is a good sign, but everytime we get to feeling good and happy with his progress, the doctors are like dont get your hopes up, just cause he can feel and do things doesnt mean anything yet. All the nurses and PT, OT, RT are happy cause it hasnt been 2 weeks since the accident.

Little One, this is EXACTLY how it was for us. When my husband was admitted, he had no sensation or movement below his nipple line. Over the next couple of weeks, he did get back the same kinds of sensations you describe, and not too long after that a little movement as well.

Now, three years later, he walks fairly well with two crutches and is working towards using just a cane. The doctors were uniformly pessimistic, just as you describe, and it fell to the nurses (one in particular) to give us reason to be hopeful. Sometimes all you have is that thin, bare reason to be hopeful! Don't let anyone take it away from you.

Of course you have to be "realistic", which means preparing yourselves for what might be a very long recovery. Bruce was pretty much stuck in the chair for 18 months, and has had to fight HARD for every tiny gain. From my experience, it's a very good sign that he's getting sensation of any kind in the first couple of weeks. Encourage him to try.

And, congratulations about the baby. http://sci.rutgers.edu/forum/images/smilies/smile.gif

[Max]

Spinal trial raises hope
THE initial trial of a controversial method for treating spinal cord injuries within two weeks of an accident suggests it may be partly successful. More patients recovered some sensation and movement than would normally be expected, the company behind the trial claims. Independent experts say the results look promising, but caution that with just 16 people treated so far, it is too early to draw any conclusions. Some worry that the technique is risky and could cause serious problems in the long term. The method involves extracting immune cells from a patient's blood, "activating" them by incubating them with skin cells, and then injecting the cells directly into the damaged spinal cord. This must all be done within 14 days of the injury, so even if larger trials confirm its benefits, the method will not help the hundreds of thousands of people worldwide with existing injuries.
The technique is being developed by ProNeuron Biotechnologies of Los Angeles, which has just submitted results from the first 10 patients for publication. All patients fell into the most severe spinal injury category, called ASIA-A. This is defined as having no sensation or ability to move below the site of injury.

Normal sensation and movement is defined as ASIA-E. According to David Snyder, vice-president of clinical
http://www.eurekalert.org/pub_releases/2004-06/ns-str060904.php

[Max]

That this topic about Proneuron trials in US should be permanent here since it gives immediate access to info for desperate families of newly paralysed people here! And it seems to be only one working therapy! in US

It seems like moderators of this forum playing "games" here http://sci.rutgers.edu/forum/images/smilies/mad.gif

[Max]

Israeli spinal cord injury therapy to establish human cell processing facility in Atlanta
Jun. 08 - Israeli company Proneuron Biotechnologies Inc. and American counterparts Cell Design LLC announced that they have entered into an agreement to establish a new human cell processing facility in Atlanta to support the current Phase II study of Proneuron's Procord, autologous incubated macrophages for complete spinal cord injury. Cell Design, a subsidiary of Cell Dynamics LLC, will provide the required cell processing facility for the manufacturing of ProCord in the southeast region of the US for this international, multi-center, randomized-controlled clinical trial. The agreement with Cell Design will support Proneuron's collaboration with the Shepherd Center in Atlanta, which is anticipated to begin enrollment in 2004 and is already taking an active role in the study. Upon receipt of the requisite approval of the US Food and Drug Administration, the facility will also provide for the commercial manufacturing of ProCord. "We are very enthusiastic about the relationship with Proneuron. Proneuron's technology provides our company with an exciting foray into the field of spinal cord research and autologous cell therapy. We very much look forward to working with this fine international team on what is clearly a very important study," said Cell Dynamics president Dr. Robert McNally. Discoveries led by Prof. Michal Schwartz of the Weizmann Institute of Science have shown in pre-clinical studies that specially treated macrophages promote recovery from spinal cord injury (SCI). Based on these findings, Proneuron is now evaluating the safety and efficacy of ProCord, currently an experimental procedure for patients with complete spinal cord injury. Complete spinal cord injury is defined as having no feeling or movement below the point of injury.

Click here (http://www.israel21c.org/bin/en.jsp?enPage=BlankPage&enDisplay=view&enDispWhat=Zone&enDispWho=InThePress&enZone=InThePress&Date=6/10/04%209:00%20PM)

[This message was edited by SCI-Nurse on 05-26-05 at 08:20 PM.]

[Max]

Spinal cord injury treatment raises hope


10:44 15 June 04

Exclusive from New Scientist Print Edition. Subscribe and get 4 free issues.

The initial trial of a controversial method for treating spinal cord injuries within two weeks of an accident suggests it may be partly successful. More patients recovered some sensation and movement than would normally be expected, the company behind the trial claims.

Independent experts say the results look promising, but caution that with just 16 people treated so far, it is too early to draw any conclusions. Some worry that the technique is risky and could cause serious problems in the long term.


http://www.newscientist.com/news/news.jsp?id=ns99995088

[Max]

Colorado hospital rejects paralyzed accident victim
Sunday, July 25, 2004
By STEPHEN HART
STATEN ISLAND ADVANCE
The family of paralysis patient Jimmy Brown received bad news late Friday night when they were told by doctors at Craig Hospital in Colorado that the Huguenot resident is not a candidate for an experimental procedure that might have eventually returned some sensation to his lower extremities.

"Everything was a go," said Jim Brown, the patient's father, regarding a scheduled trip tomorrow to Craig Hospital in Englewood, Colo. "The people here (at the University of Medicine and Dentistry in Newark, N.J.) were congratulating us, and some of the doctors were planning to go with us. But then I got the call from Craig and they told me Jimmy wasn't accepted. I just went blank after that."

http://www.silive.com/news/advance/index.ssf?/base/news/109076146047930.xml

[JDR]

Dive victim is candidate for experimental treatment
Huguenot resident partially paralyzed after swim accident will fly to Colorado for evaluation
Saturday, July 24, 2004
By STEPHEN HART
%%sourceline%% STATEN ISLAND ADVANCE

A window of opportunity has opened for Jimmy Brown. But there's a chance it could be cruelly closed on him.

Full Article Here (http://www.silive.com/search/index.ssf?/base/news/109067503519010.xml)

"Why am I a Democrat?...Because nobody ever wanted a piece of elephant." ~Seen on a button at a recent Kerry/Edwards Rally

[JDR]

Experimental spine procedure has had success
Huguenot resident might be picked for Proneuron Biotechnology's ProCord test
Saturday, July 24, 2004
By STEPHEN HART
ADVANCE STAFF WRITER
Melissa Holley was your typical college student, working two waitressing jobs back home in the summer after her freshman year. But what happened on the afternoon of June 25, 2000, certainly wasn't ordinary.

As she headed to work in Ridgway, Colo., Ms. Holley's car failed to make a turn and flipped over several times. She blacked out, waking up in a hospital with a "complete" spinal-cord fracture of the T6/T7 vertebrae.

Full Article Here (http://www.silive.com/search/index.ssf?/base/news/109067496619010.xml)

Corrections
Sunday, July 25, 2004
Justin Richardson, a recovering spinal-cord injury patient who underwent Proneuron Biotechnology's ProCord Phase I procedure, has...Full Correction Here (http://www.silive.com/search/index.ssf?/base/news/109076142347930.xml)

"Why am I a Democrat?...Because nobody ever wanted a piece of elephant." ~Seen on a button at a recent Kerry/Edwards Rally

[Max]

Proneuron Biotechnologies Welcomes Dr. Marca L. Sipski to the Company's ProCord Study Steering Committee Guiding the Phase II Study of ProCord for Complete Spinal Cord Injury

LOS ANGELES--(BUSINESS WIRE)--Sept. 7, 2004--Proneuron Biotechnologies announced today that Dr. Marca Sipski is the newest member of the Company's Procord Study Steering Committee, tasked to oversee the Phase II study of ProCord, an experimental procedure for complete spinal cord injury now in progress in the U.S and Israel.


Dr. Sipski is a Professor of Rehabilitation Medicine at the University of Miami School of Medicine and the Director of a VA Rehabilitation Research Center of Excellence in Spinal Cord Injury. She is the President-Elect of the American Spinal Injury Association (2003-2005) and the author of tens of books, monographs, chapters, original peer-reviewed articles, academic and consumer publications, and abstracts pertaining to spinal cord injury.

Click here (http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20040907005427&newsLang=en)

[This message was edited by SCI-Nurse on 05-26-05 at 08:19 PM.]

[Max]

Proneuron's ProCord receives FDA orphan drug designation

ProCord is an experimental procedure for complete spinal cord injury.

Globes correspondent 13 Sep 04 14:13

Proneuron Biotechnologies announced today that the US Food and Drug Administration (FDA) has granted an orphan drug designation to ProCord, autologous incubated macrophage therapy, to improve the motor and sensory neurological outcome in cases of acute spinal cord injury.
In the U.S. alone, there are an estimated 11,000 new spinal cord injuries per year.

Orphan drug status is granted by the FDA Office of Orphan Products Development (OOPD) to promote the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In order to qualify as an orphan drug, a product must target conditions that affect less than 200,000 people a year in the U.S. and that should offer substantially improved therapeutic benefit as compared to current medical regimens. Orphan drug designation provides for seven years of market exclusivity in the U.S. to the first entity that obtains marketing approval in the designated indication. Other benefits to the sponsor include tax credits for the costs of clinical research, reduced filing fees and preferential pre-filing regulatory guidance.

http://www.globes.co.il/serveen/globes/docview.asp?did=836613&fid=942

[Max]

Christopher Reeve was firm believer in Israel's stem cell research
Oct. 11 - The late Christopher Reeve was one the biggest supporters of Israeli stem cell research related to paralysis and spinal cord injuries. Calling Israel the "world center" for research on paralysis treatment, Reeve visited the country last year to learn first hand the developments taking place. "Israel is the center of some of the world's leading research related to paralysis. There are many new therapies in the pipeline as well as care strategies being employed that may also benefit millions of people around the world living with paralysis. This includes therapies derived from stem cell research," Reeve said at the end of his visit. During the trip, Reeve met with neuroimmunologist Michal Schwartz of the Weizmann Institute in Rehovot. "She [Schwartz] and some of her colleagues are doing particularly well in treating patients immediately after spinal cord injuries in what is called the acute phase. If a person can be treated right away, within the first 10 days after the injury, it will have dramatic effect in what their life will be." Schwartz described her team's approach of therapy as "different than any other group in the world." The work is being carried out by an Israeli company called Proneuron Biotechnologies, Inc. The therapy, recently began Phase 2 FDA approved clinical studies in the U.S. Proneuron's treatment, involves isolation of macrophages from the patient's blood, processing in the laboratory and then injection of the cells into the spinal cord in the vicinity of the area of damage. The treatment, which must be provided within 14 days of spinal cord injury, requires a surgical procedure to open the spine for the injection of the macrophage cells into the spinal cord.

Click here (http://www.israel21c.org/bin/en.jsp?enPage=BlankPage&enDisplay=view&enDispWhat=Zone&enDispWho=InThePress&enZone=InThePress&Date=10/11/04%2011:00%20PM)

[This message was edited by SCI-Nurse on 05-26-05 at 08:18 PM.]

[Max]

Reeve's Death Felt In Israel

- Staff Report

The death on Sunday of actor Christopher Reeve at 52 had special meaning in Israel, where Reeve visited last year to support the country's research on treatment of paralysis. Reeve, who suffered a debilitating spinal cord injury during a riding accident in 1995, had become a spokesman for spinal cord research.

During his five-day visit in Israel, he toured several Israeli hospitals and met paralyzed Israelis, including terror victims and former soldiers. He called Israel "the center of some of the world's leading research related to paralysis," and praised Dr. Michal Schwartz, of the Weizmann Institute's neurobiology department, who has implanted a special type of blood cell into the spinal cords of acutely injured patients within two weeks of their accidents.

"The one that was stunning to me was the 30-year-old who two years ago was shot and his spinal cord was completely severed, which is much worse than my injury," Reeve said. "And when I met him ... he's walking."

"He was a great example to our graduates when he spent the day with us," said Dr. Shirley Meyer, director-general of the Alyn Orthopedic Hospital and Rehabilitation Center in Jerusalem.

http://www.thejewishweek.com/news/newscontent.php3?artid=9993

[Max]

ProCord Trial for Complete Spinal Cord Injury Now Live at Shepherd Center in Atlanta
Shepherd Center announced today 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.
Click here (http://www.genengnews.com/news/bnitem.aspx?name=536329XSL_NEWSML_TO_NEWSML_WEB.xm l)



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[This message was edited by SCI-Nurse on 05-26-05 at 08:17 PM.]