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Intraspinal Stem Cell Transplantation in ALS: A Phase I Safety Trial, Technical Note & Lumbar Safety Outcomes
' Z6 F  b3 x2 q/ ]/ L1 y, e1 RRiley, 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 MD7 u% `% n& v5 w6 r1 ?7 y  W3 z
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Neurosurgery: . N5 o5 {* U8 x/ \
POST ACCEPTANCE, 4 May 2012
; @7 S  X) X6 @doi: 10.1227/NEU.0b013e31825ca05f
8 C2 W; k7 M+ }7 u/ mRESEARCH-HUMAN-CLINICAL STUDIES: PDF Only4 s7 {9 M( w; |9 y

4 E7 P. {+ S8 |Abstract
: i+ {5 e- x4 {  W. Y3 ], LBackground: 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.
# f3 M+ p, @* R) l, U1 H. \! CObjective: 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.# L! Q+ o: B- z. s: p
Methods: 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) \3 ]- F& O' [- }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./ I# ]6 L, Z0 W: Y2 c
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.) @; T& c. Q4 l, F% n
Copyright (C) by the Congress of Neurological Surgeons
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链接：4 P; N" M6 b, D/ Q( K
http://journals.lww.com/neurosur ... _ALS___A.98759.aspx
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