[Bevan-L]

I emailed Geron enquiring about their clinical trials, this was the reply i received... thought I'd share with everyone who is interested... guess we'll have to wait a bit longer b4 we get to try heh


Dear Bevan


Thank you for your interest in Geron’s human embryonic stem cell (hESC) program and GRNOPC1.



Geron plans to initiate a Phase I multi-center trial that is designed to assess the safety and tolerability of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries. Patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between 7 and 14 days after injury.



The Phase I trial of GRNOPC1 has not yet been initiated and therefore enrollment of potential patients has not begun. Several additional steps need to be completed at each clinical trial site before they are ready to enroll for the study. These additional steps can typically take at least 3 to 6 months to complete. Please also be advised that GRNOPC1 must be injected within 7 to 14 days following injury, so the only patients who will potentially be eligible to participate are patients injured after the trial begins.



The rationale for administering GRNOPC1 between 7 and 14 days after injury in this trial is based on our preclinical studies in animal models of spinal cord injury. In those studies, GRNOPC1 was effective only if injected soon after the injury and we believe that this is due to the formation of scar tissue that occurs in the spinal cord in the weeks after injury.



A document with information on hESCs, GRNOPC1 and the planned clinical trial is attached for your reference. Information regarding the planned clinical trial of GRNOPC1 can also be found at http://www.geron.com...rials/hESC.aspx. You may also be interested to know that on our website there are links to additional sites with information on spinal cord injury provided by other organizations at: http://www.geron.com/patients/diseaseinfor...ordinjury.aspx/.



Thank you for your patience while waiting for this response.



Sincerely,

Anna



Anna Krassowska, Ph.D.

Public Relations

Geron Corporation

www.geron.com

[Reach For The Sun]

I just read about this in the latest popular science magazine...very interesting and hopeful stuff...keeping my fingers crossed that it does well...or we can kiss our government funding goodbye....

[Hikkakaru]

Subacute within two weeks of injury, but with documented proof that it's a COMPLETE ASIA A within a thoraic injury? That severely limits trials. With the amount of force that a lot of thoraic injurys see the patient is barely medically stable, let alone ASIA assessed within that time frame. Dr. Wise Young has even said that the only ASIA suitable test to assess complete versus incomplete is the dull/sharp pin prick sensation test, which usually isn't used until later phases of the injury, far past achieving medical stability, and far past the time limits of this trial.