ROCKVILLE, Md., June 5, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that the Emory University Institutional Review Board (IRB) approved the amendment to the ongoing Phase I trial evaluating Neuralstem's spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The amendment permits the return of three previously-treated patients to the trial to receive additional injections of cells. This modification to the protocol was approved earlier by the Food and Drug Administration (FDA). Implementation was contingent upon IRB approval, which has now been secured.

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"Bringing patients back for a second set of injections should they meet the inclusion requirements at the time of surgery, or giving new patients both lumbar and cervical injections, is a major step forward toward testing the maximum safe dosing of our cell therapy," said Richard Garr, Neuralstem President & CEO. "We have been encouraged by the results of the trial to date, and are eager to commence treating patients with this increased dosage."

About the Study

The ongoing Phase I study is designed to assess the safety of Neuralstem's spinal cord stem cells (HSSC's) and transplantation technique in up to 18 patients with ALS.

The first twelve patients were all transplanted in the lumbar (lower back) region of the spine. Of these, the initial six (Cohort A) were all non-ambulatory with permanent paralysis. The first patient was treated on January 20, 2010. Successive surgeries have followed at the rate of one every one-to-two months. The first three patients (Cohort A1) were each treated with five unilateral HSSC injections in L2-L4 lumbar segments, while the next three patients (Cohort A2) received ten bilateral injections (five on each side) in the same region. The next six patients (Cohort B and C) were all ambulatory. Of these, the first three (Cohort B) received five unilateral injections in the L2-L4 region. The last three patients (Cohort C) in this study group received ten bilateral injections in the same region.

The trial was then approved to progress to cervical transplantations, with two cohorts of three patients (Cohort D and Cohort E). Cohort D has received five injections in the cervical region of the spinal cord. Cohort E will receive a total of fifteen injections, five in the cervical region and ten in the lumbar region.

About Neuralstem

Read more from the original source:
Neuralstem Updates ALS Stem Cell Trial Progress; Emory University Institutional Review Board Approves Amendment