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First patient treated in neuralstem phase 1 spinal cord injury stem cell trial.

GERMANTOWN, Md" October 9, 2014--Neuralstem, Inc. (NYSE MKT: CUR) announced that the first patient was treated last week in the Phase 1 trial testing NSI-566 human neural stem cells in the treatment of chronic spinal cord injury (cSCI) at the UC San Diego School of Medicine.

The patient has been discharged from the hospital.

The NSI-566/cSCI Phase 1 trial will treat four patients who have thoracic spinal cord injuries (T2T12) with stem cell transplants directly into the region of the injury, between one and two years post-injury.

All of the patients have an American Spinal Injury Association (AIS) grade A level of impairment, which is complete paralysis with no motor or sensory function in the relevant segments at and below the injury. The trial is under the direction of principal investigator (PI) Joseph Ciacci.

Much of the preclinical work with the NSI-566 cells in spinal cord injury was conducted at UC San Diego School of Medicine by Martin Marsala.

According to company executives, the therapeutic mechanism of action for the neural stem cell transplantation in chronic spinal cord injury is for the transplant to "bridge the circuitry gap" in the cord which resulted from the injury.

To return meaningful function to the patients, existing nerves from above the injury will need to traverse and connect to the intact area below the injury.

The new nerves generated from the transplant itself can connect to the host cord above and below the injury and contribute to the rebuilding of the damaged circuitry, as demonstrated in animal studies (Lu, Gorp).

This structural repair by NSI-566 in chronic SCI patients will be in addition to the neuroprotective factor expression demonstrated in ALS patients who have undergone transplantation with the same cells.

This clinical trial, funded by Neuralstem, was launched and supported by the UC San Diego Sanford Stem Cell Clinical Center.

The goal of the study is to evaluate the safety of transplanting neural stem cells into the spine for what could one day be a treatment for spinal cord injuries.

The study's immediate goal, however, is to determine whether injecting these neural stem cells into the spine of patients with spinal cord injury is safe.

There are more than 10,000 new spinal cord injuries (SCI) in the U.S. each year.


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Title Annotation:In The Clinic
Publication:Stem Cell Lab World
Date:Oct 20, 2014
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