Clinical trials on spinal cord injuries – collaboration between USA and Norway

[Leif]

Hi, here is some news that could be interesting.

Norway has decided to collaborate with the United States to start clinical trials for people with chronic spinal cord injury.

History
In connection with the ISCoS Congress in Florence, Italy, 21st to 24th October 2009 there was held special symposia focusing on advanced research for clinical trials for the repair of spinal cord injuries.

U.S. scientists by professor Wise Young MD, Ph.D. from the WM Keck Center and Rutgers University in New Jersey, USA, gave a speech the 23rd October in the main auditorium where clinical trials on chronic spinal cord injury was the main focus. U.S. scientists with over 10 University Hospitals and SCI rehabilitation institutions now want to start a multicenter study - clinical trials - on humans in the chronic phase of spinal cord injury. These centers will start clinical trials with UCBMC (umbilical cord blood mononuclear cells) and lithium treatments on people in the chronic phase of spinal cord injury. Laboratory studies have so far shown that such treatment in animal experiments can stimulate neurotrophins for new regeneration, axon growth, in the injured spinal cord. One would then transfer these laboratory studies to the clinics to start clinical trials on humans. The Americans with the involved centers have established the SCINetUSA aiming to start the clinical trials on humans with spinal cord injury. It has set up a protocol committee to work out the final documentation, as a wish to send to the FDA (Food and Drug Administration, U.S. health authorities) for approval in 2010.

The Americans have UCBMC and lithium as part of the therapies they want to try in these clinical trials – the first in the world – clinical trials on humans with chronic spinal cord injury, but encourages the involved centers to suggest other therapies from the laboratories which one also can transfer to the clinics with studies in humans.

Norwegian collaborations with the U.S.
In connection with the ISCoS Congress were also doctors from Norway present. And in connection with the interesting and important speech for the planned clinical trials in the United States, discussions with Dr. Wise Young were established. One found this so interesting that one started discussions on Norway to join this partnership with the Americans and be a part of these multicenter studies. The American professor (Dr. Wise Young) was very positive about this, and justified this with the fact that Norway has all the qualifications necessary to perform such experiments, it was mentioned; very good morals and high academic standard of Norwegian researchers, very high professional quality and competence of Norwegian clinicians, good rehabilitation institutions where one follow-up spinal cord injured peoples over time and that Norway has a unique strong economy to perform advanced clinical trials on spinal cord injuries.

Communication with the Americans is established and one is now in dialogue for discussing the details for the collaboration project.

This will be a national effort in Norway where several University Hospitals, the spinal cord units, the University in Oslo and the new National Stem Cell Center will participate. There is now established a task group with representatives from patient (user) organizations, neuroscientists and clinicians. The aim is to start planning clinical trials for spinal cord injuries drawing on all available expertise in Norway. The planning will involve financial as well as ethical and scientific issues. There has been held several meetings so far. The last meeting was 16th December where several scientists, clinicians and representatives from user organizations participated. The next meeting is planned early 2010 with American scientist Dr. Wise Young.

Personal notes
The meetings in Norway so far have been 100 % positive. All involved in Norway has been very proactive and very positive. The meetings has been unique where all participants has been focused on the task, probably some of the best meetings I have participated in. And all look forward to this collaboration with the US. In the meetings several great ideas has been suggested for this collaboration, but that has to be communicated in the next meetings. One could update here in this thread later on then.

Here is also a link to the Norwegian spinal cord injuries magazine Patetra December issue where all this is discussed (see from page 12 to page 15. It’s in the Norwegian language, but is says basically what I have posted here.): http://regioner.nhf.no/novus/upload/...%202009-04.pdf

I think this is very good news for all of us. I think the US and Norway can make 2010 a turning point for clinical trials for persons with spinal cord injuries. One also welcomes other countries to participate.

I also want to say if it was not for Dr. Wise Young’s constant good efforts this would not have happened. So a special thank you Dr. Young and a happy New Year!

Thank you also to Paolo Cippola and others for the great efforts at the ISCoS Congress in Italy, many others also, and a happy new 2010 clinical trial year to all of you!

Leif