FDA asked for information on manufacturing process and delivery device and to make changes to trial protocol.

Neuralstem reports that its spinal cord stem cell trial to treat ALS is on clinical hold. FDA has provided the company with specific comments, questions, and recommendations for modifications to its protocol.

“The FDA has presented us with their review of our entire investigational new drug application,” explains Richard Garr, Neuralstem’s president and CEO. “They have asked for some additional information regarding our product manufacturing process and preclinical studies as well as our novel clinical delivery injection device and technique.

“The agency has also requested various modifications to the protocol and eligibility criteria for patients in the trial as well as slight changes to the timing of the surgeries,” Garr adds. “Overall we believe the agency’s comments and recommendations are extremely helpful.”

Neuralstem’s technology reportedly enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia.


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