|07-06-2012, 05:31 PM||#1|
Join Date: Sep 2004
Intraspinal Stem Cell Transplantation in ALS: A Phase I Safety Trial
Neurosurgery. 2012 May 4.
Intraspinal Stem Cell Transplantation in ALS: A Phase I Safety Trial, Technical Note & Lumbar Safety Outcomes.
Riley J, Federici T, Polak M, Kelly C, Glass J, Raore B, Taub J, Kesner V, Feldman EL, Boulis NM.
1Department of Neurosurgery - Emory University, Atlanta, GA 2Department of Neurology - Emory University, Atlanta, GA 3Department of Neurology - University of Michigan, Ann Arbor, MI.
No US-based clinical trials have attempted delivery of biologic therapies directly to the spinal cord for treatment of ALS, due to the lack of a meaningful FDA-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 FDA-authorized Phase I trial.
Each microinjection series was comprised of five injections (10μl/inj) separated by 4mm. 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, non-ambulatory 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 been transplanted. There was one instance of transient intra-operative somatosensory-evoked potentials depression. In the immediate post-operative period there was one episode of urinary retention requiring foley catheter re-insertion. By discharge, none had a documented motor function decrement. Two required re-admission and re-operation for CSF leak or suprafascial wound dehiscence (n=1 each). Two deaths occurred at 8 and 13 months post surgery, neither related to the surgical transplant.
Our experience in 12 patients supports the procedural safety of unilateral and bilateral intraspinal lumbar microinjection. Completion of this Phase I safety trial is planned by proceeding to cervical and combined cervical + lumbar microinjections in ALS patients.
“As the cast of villains in SCI is vast and collaborative, so too must be the chorus of hero's that rise to meet them” Ramer et al 2005
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