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Intraspinal Stem Cell Transplantation in ALS: A Phase I Safety Trial, Technical Note & Lumbar Safety Outcomes1 ~! i6 a9 a% _6 @; x
Riley, Jonathan MD; Federici, Thais PhD; Polak, Meraida BSN RN; Kelly, Crystal MPH; Glass, Jonathan MD; Raore, Bethwel MD; Taub, Jason MD; Kesner, Vita MD PhD; Feldman, Eva L MD PhD; Boulis, Nicholas M MD1 j% O3 L8 L% K8 p% ~+ V, n

& p. D6 q: k5 A! K6 n& {2 ~Neurosurgery:
, L: [; h7 u: A# _0 PPOST ACCEPTANCE, 4 May 2012- ]+ t* d& o7 C9 p
doi: 10.1227/NEU.0b013e31825ca05f7 d+ @' Q) L: ?8 ^$ N$ I3 B
RESEARCH-HUMAN-CLINICAL STUDIES: PDF Only" D" J* b0 {+ K# K

8 B! T0 s7 w: H$ cAbstract, l, T' t. J4 R4 ^1 o2 p3 g( t$ s
Background: 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.2 j: A: n7 r# P# |1 y
Objective: 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.
$ U* p( z; u1 E, MMethods: Each microinjection series was comprised of five injections (10[mu]l/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., H% b2 a. [8 [3 v$ r
Results: 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.2 }* w$ z$ n6 Q/ S6 R
Conclusion: 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.) }- S( Q7 f5 G; k& s8 \2 q4 R4 _
Copyright (C) by the Congress of Neurological Surgeons
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4 j% w; c4 l- z- \( i+ Thttp://journals.lww.com/neurosur ... _ALS___A.98759.aspx8 \; r% p  t# f8 f; u