Cell Therapy Treatments in Development

  • ALS

FDA-approved multi-center dose-escalation Phase II NSI-566/ALS clinical trial primarily evaluating safety concluded in 1Q15. Larger, controlled, registration directed NSI-566/ALS clinical trial expected to commence in 2016. More

  • Spinal Cord Injury

FDA-approved Phase I safety trial transplanting NSI-566 into the T2-T12 lumbar regions of four chronic SCI patients completed the last surgery in July 2015, with six-month post-observation period, at University of California, San Diego School of Medicine. Acute SCI Phase I/II trial in Seoul, South Korea, awaiting IND approval. More

  • Ischemic Stroke

NSI-566 Phase I / II trial for ischemic stroke commenced in December 2013, in collaboration with BaYi Brain Hospital in Beijing. Phase II controlled proof-of-concept study commencement expected in 2016. More

  • Multiple Sclerosis

Preclinical phase with NSI-566. Further clinical development on multiple sclerosis application pending NSI-566 ALS ongoing trial.

  • Optic Neuritis

Preclinical phase with NSI-566. Further clinical development on optic neuritis application pending NSI-566 ALS ongoing trial.

Preclinical phase with HK532-IGF-1, human cortex-derived neural stem cells that have been engineered to secrete human insulin-like growth factor 1 (IGF-1). In animal data presented at the Congress of Neurological Surgeons 2014 Annual Meeting, the cells rescued spatial learning and memory deficits in an animal model of Alzheimer’s disease. Additional animal data presented at the International Society for Stem Cell Research 2015 Annual Meeting showed a beta-amyloid plaque reduction in both the cortex and hippocampus; amyloid plaque is one of the two hallmarks of AD.

  • Traumatic Brain Injury

Preclinical phase with NSI-566. Further clinical development on traumatic brain injury application pending NSI-566 ALS ongoing trial.

  • Peripheral Nerve Injury

Preclinical phase with NSI-566. Further clinical development on peripheral nerve injury application pending NSI-566 ALS ongoing trial.

  • Diabetic Neuropathy

Preclinical phase with NSI-566. Further clinical development on diabetic neuropathy application pending NSI-566 ALS ongoing trial.

  • Lysosomal Diseases

Preclinical phase with NSI-566. Further clinical development on lysosomal diseases application pending NSI-566 ALS ongoing trial.

  • Parkinson’s Disease

Preclinical phase with NSI-566. Further clinical development on Parkinson’s disease application pending NSI-566 ALS ongoing trial.

  • Huntington’s Disease

Preclinical phase with NSI-566. Further clinical development on Huntington’s disease application pending NSI-566 ALS ongoing trial.

  • Cerebral Palsy

Preclinical phase with NSI-566. Further clinical development on cerebral palsy application pending NSI-566 ALS ongoing trial.

  • Ischemic Spastic Paraplegia

Preclinical phase with the University of California at San Diego. Lead collaborator, Dr. Martin Marsala, PhD authored a peer-reviewed paper on study results. More

Drug Treatments in Development

  • Major Depressive Disorder

Multi-center neurogenic small molecule drug NSI-189 Phase II first patient enrollment expected in 1Q 2016. Phase I NSI-189/MDD trial concluded in 4Q13, with data first presented in June 2014 showing statistical significance; and clinically meaningful improvement across all depressive and cognitive measures. More

  • Alzheimer’s Disease

Preclinical phase with NSI-189, which was originally developed to address cognitive indications. Further clinical development on Alzheimer’s disease application pending NSI-189 major depressive disorder ongoing trial.

  • Cognitive complication due to Diabetes

Preclinical phase with NSI-189. Further clinical development on cognitive complication due to diabetes application pending NSI-189 major depressive disorder ongoing trial.

  • Stroke

Preclinical phase with NSI-189. Further clinical development on stroke application pending NSI-189 major depressive disorder ongoing trial.

  • Traumatic Brain Injury

Preclinical phase with NSI-189. Further clinical development on traumatic brain injury application pending NSI-189 major depressive disorder ongoing trial.

  • Post-Traumatic Stress Disorder

Preclinical phase with NSI-189. Further clinical development on PTSD application pending NSI-189 major depressive disorder ongoing trial.

  • Neurodegeneration

Preclinical phase with NSI-189. Further clinical development on neurodegeneration application pending NSI-189 major depressive disorder ongoing trial.

  • Anti-Aging (Nootropic)

Preclinical phase with NSI-189. Further clinical development on anti-aging (nootropic) application pending NSI-189 major depressive disorder ongoing trial.

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