Intraspinal stem cell transplantation in amyotrophic lateral sclerosis: a phase I safety trial, technical note, and lumbar safety outcomes

Neurosurgery
Jonathan RileyNicholas M Boulis

Abstract

No United States-based clinical trials have attempted delivery of biological therapies directly to the spinal cord for treatment of amyotrophic lateral sclerosis (ALS) because of the lack of a meaningful US Food and Drug Administration-authorized cell candidate and a validated delivery approach. To assess safety of delivery of a neural stem cell-based treatment into the upper lumbar segments of the ALS spinal cord in the first US Food and Drug Administration-authorized phase I trial. Each microinjection series comprised 5 injections (10 μL/injection) separated by 4 mm. Each injection deposited 100,000 neural stem cells derived from a fetal spinal cord. Twelve patients were treated with either unilateral or bilateral injections. Group A, nonambulatory patients, underwent unilateral (n = 3) or bilateral (n = 3) lumbar microinjections. Groups B and C were ambulatory (n = 3 each) and, respectively, received unilateral or bilateral injections. Patients are followed clinically and radiologically to assess potential toxicity of the procedure. Twelve patients have received a transplant. There was one instance of transient intraoperative somatosensory-evoked potentials depression. In the immediate postoperative period, there was 1 episo...Continue Reading

References

Oct 14, 2006·Transplantation·Leyan XuVassilis E Koliatsos
Dec 13, 2007·Stereotactic and Functional Neurosurgery·Jonathan RileyNicholas M Boulis
May 7, 2010·Clinical and Translational Science·Thais FedericiNicholas Boulis
Apr 8, 2011·Neurosurgery·Jonathan P RileyNicholas M Boulis

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Citations

Apr 16, 2014·Journal of Nanoscience and Nanotechnology·Lukui ChenQiang Xu
Nov 16, 2013·Therapeutic Delivery·Jason J LamannaNicholas M Boulis
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