In a message dated 9/29/2011 3:02:39 P.M. Central Daylight Time,
[email protected] writes:
Clinical Trial Application Submitted to FDA to Test Safety of Schwann
Cells
The Miami Project is happy to tell you that we have submitted our
application to the FDA to request permission to start a phase 1 clinical trial
to
test the safety of injecting Schwann cells into people with SCI. We now
have to wait for a response from the FDA.
This first trial is purely testing safety, because we have to do surgery
on people and actually stick a needle into their spinal cord injury site in
order to put their Schwann cells inside. It will only involve about 8
people and they will all be new injuries. The main reason we are doing new
injuries first is because we have more animal data in that setting and it
allows us to get FDA approval faster. Getting faster FDA approval means going
into people faster, which means finding out about safety faster. As soon
as we know it is safe to inject, we can then start additional trials
expanding into chronic injuries, incomplete injuries, and even combination
therapies (which will likely be much more effective at restoring function to
people than just Schwann cells by themselves – or anything by itself for that
matter).
So think of this as our building block to developing the most effective
treatments for people living with SCI. The best way to get access to these
treatments fastest is to keep yourself healthy and in very good condition so
that you qualify for clinical trials as they become available and for
which you qualify. For treatments to go all the way through multiple clinical
trials and become mainstream medical practice in the “clinic” could take
10-15 years or more depending on the intervention. But participating in
clinical trials not only helps us get there faster, but also benefits the
clinical trial participants faster than the rest of the public.
New PROJECT magazine available
The newest edition of The PROJECT magazine is available! Research
articles include information about the proposed Schwann cell therapy trial,
current clinical trials for SCI, combination treatments, intellectual
property,
science education, a visit from Rick Hansen, and SCI awareness month.
Research Survey Opportunity
Research opportunity for people with paralysis to participate in a Miami
Project _online survey_
(http://www.surveymonkey.com/s_pass.aspx?sm=rUOnvgkL0eUlWXUY9WVjug==) about
sleep habits and problems associated with spinal cor
d injury! To obtain a password email [email protected]_
(mailto:[email protected])
Stay Informed of All Registered Clinical Trials and Studies
The best way to stay informed about all currently registered clinical
trials and studies is to log on to _www.clinicaltrials.gov_
(http://www.clinicaltrials.gov/) periodically. You can enter the search
phrase “spinal cord
injury”. You’ll be amazed at how many are really out there!
Life in Action
The new SCI publication, _Life in Action_
(http://issuu.com/life_in_action/docs/lia_jul_aug_11?mode=window&backgroundColor=#222222)
, is available
online from the recently merged National SCI Association and United Spinal
Association. Stay in touch and stay informed!
Kim Anderson-Erisman, Ph.D.
Director of Education
The Miami Project to Cure Paralysis
Lois Pope Life Center
1095 NW 14th Terrace, Room 1-31, Mail Locator R-48
University of Miami
Miami, FL 33136
Office: 305-243-7108
Fax: 305-243-3913
[email protected]_ (mailto:[email protected])
_www.miamiproject.miami.edu_ (http://www.miamiproject.miami.edu/)
