• Time is the longest distance between two places

Posted: October 22, 2009

“Time is the longest distance between two places.”

- Tennessee Williams (playwright)

And so it seems to all of us at Neuralstem, and (from your emails) to many of you also. In late September the FDA approved our trial to treat ALS with our spinal cord stem cells. The distance we want to traverse of course is between that approval and the trial itself. The process for getting from here to there is not generally understood, so I hope to shed some light on it here. We are now in the process of having the protocol that the FDA approved for the conduct of the trial, approved by the Institutional Review Board (IRB) of Emory University where we expect to conduct the trial. Approving the trial at the site level is not a trivial step.

The FDA’s approval can be thought of as a scientific and medical exercise. And while they put a tremendous amount of effort into analyzing issues regarding patient safety, it is almost in the abstract. That is, their approval is not “site” specific. Technically the protocol can be carried out at any qualified site. A University’s IRB however must take into account its own ethical guidelines and patient specific rules and relationships when reviewing various parts of the protocol (such as the patient consent forms). And since ultimately the University is responsible for the patients, certainly they must take into account theirs own calculation of various risks. This is how it must and should be. The IRB’s main goal is promote safe and responsible human trials that balance the need for moving forward experimental therapies with the rights of patients. But the rights and the safety of their patients is their primary responsibility. And they have a very structured and time tested review system for making this evaluation. In the end, even if modifications to some parts of the existing protocol are required, it will be because that is what is really needed to properly balance these (sometimes) competing goals.

If I could impress upon everyone one point, it would be that the IRB approval process is in every sense of the word, a collaborative process not an adversarial one. We are working WITH Emory’s IRB to make sure that we have “got it right”, and they are good partners. I can also tell you that together with the Emory trial team and their IRB, we are pushing the system as hard and as fast as it can be pushed without threatening the quality and integrity of the review process.

Everyone involved in this trial, from Neuralstem to the Principal Investigators to the surgical team to the Emory IRB wants to move this forward as quickly as it can reasonably be done. I have stated publicly that I believed we would start the trial this year, and I still think that is the case. Yet to us, as well as to those of you in the ALS community, it does seem as though the wait is endless. Time, no matter whether it is measured in months or even weeks, is indeed the longest distance between any two points.