Safety Study of GRNOPC1 in Spinal Cord Injury 7 Z: a5 g4 R* M% l4 MThis study is currently recruiting participants. 6 Z3 {0 _& d2 n& D. Z6 L# qVerified by Geron Corporation, October 2010 . a* t- K0 ]9 H+ h+ B) YFirst Received: October 6, 2010 Last Updated: October 7, 2010 History of Changes ! k, P8 h, B2 t8 U2 _
Sponsor: Geron Corporation ; J3 x1 v6 [# C3 j! _( oInformation provided by: Geron Corporation; ~% v) @, w& g8 A Y8 {5 D5 d
ClinicalTrials.gov Identifier: NCT01217008 1 d! D9 P, H& P2 q- X# z Purpose ; B3 H% f7 H c. C& F9 A/ \3 E6 a
The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI). : Z! t! K q) H. H6 i' A3 \& l* O2 `$ z- ?
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Condition 1 H9 h7 n3 T6 Z4 VIntervention 3 x$ J. \* }( P' W. Z; ?, ~Phase 8 ]. m" b, Y( n; W ; [3 O4 i1 |: e; `7 O, f: ZSpinal Cord Injury Biological: GRNOPC1 Phase I- L u2 J: E, V5 g
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Study Type: Interventional % ?1 T0 y3 M( q1 T# j$ Z, k
Study Design: Allocation: Non-Randomized ) h7 h$ G! }/ T2 v2 lControl: Uncontrolled ' V$ a) s! _: u# g" b- O& {Endpoint Classification: Safety Study/ ~5 z2 i5 w6 K% R7 Q: O
Intervention Model: Single Group Assignment ( o2 J) ~6 S1 S, s* p0 \Masking: Open Label # ~* |' p! y3 ?: MPrimary Purpose: Treatment ; j* D% J. \& r P) TOfficial Title: A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury' J8 P n, H1 x% N; f
; _/ @* ^# P6 vResource links provided by NLM:- k+ a# m6 k: _0 F, z6 T9 h
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MedlinePlus related topics: Spinal Cord Injuries : K+ e; ]. ?1 ]+ _U.S. FDA Resources ' L) V8 v: Q( J 5 j ?9 K. U8 Y7 Z% fFurther study details as provided by Geron Corporation: 7 g' |8 p% S9 x# Y; j$ l+ @' l9 u4 o% }8 w# @- ~1 ?& ^
Primary Outcome Measures: 2 {- y" `) u7 K) S9 e8 F# F6 W
• Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ] + M# B% _' P8 i0 I+ O2 N8 DThe primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered. 1 j; a" d9 H" M2 y3 r a+ }' b |$ a; c: u! O
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4 p) L! _, s8 T: @* _Secondary Outcome Measures: ; G4 M0 @: Z7 E# k. w) c" x5 g+ Y• Neurological function [ Time Frame: One year ] [ Designated as safety issue: Yes ] 1 L/ P5 E+ ?6 b) CThe secondary endpoint is neurological function as measured by sensory scores and lower extremity motor scores on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations.4 ~' C6 w( J- y5 p: X- _
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3 Q5 K' Q( F4 h" A' l# rEstimated Enrollment: 10 ) l3 Y6 ~- m; c- _( q( ]Study Start Date: October 2010 ) f3 Y! d( B; r7 g1 Z- M/ c pEstimated Study Completion Date: October 2012 . h1 i# }4 {% xEstimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure) ' [- g5 ?6 u: H, j4 `: L/ w2 uArms 8 o' [( A: v& K z. Z, U. V* |; iAssigned Interventions 9 T& M7 W+ @0 y) B5 _, H 4 m& @$ Z4 n" a/ h8 ^. U q( dGRNOPC1: Experimental 6 K3 p" Z9 W4 s* G
Subjects who receive an injection of GRNOPC1) q% j( Q- L8 J8 O
Intervention: Biological: GRNOPC1 Biological: GRNOPC1 ) c, m D6 J4 A- K* s7 T6 ]9 S
One injection of 2 million GRNOPC1 cells. 7 ^1 {6 |0 z% d+ [ . c$ Z) q' O5 w% k# |3 Q" s" ?" |9 R0 |9 r, R% k
Eligibility / Z- s( Z2 k$ ]3 [' fAges Eligible for Study: 18 Years to 65 Years & ?% M# |4 Q2 a; Y& kGenders Eligible for Study: Both& h+ p! d7 N X
Accepts Healthy Volunteers: No 6 ^+ V9 f7 f ~! S0 F- t( ]Criteria% `; f0 s0 q' C& k1 k+ |0 W& G9 r
Major Inclusion Criteria: 9 H" g) z/ k6 b7 \5 {• Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels ( R. W3 i1 [! b7 P3 A/ p
• Last fully preserved neurological level from T-3 through T-10 : D$ [' n1 e; e$ x: I, N' T
• From 18 through 65 years of age at time of injury C( }3 s! J5 w3 L- E; }, [8 e
• Single spinal cord lesion 1 ~# X; m6 I& f3 J0 w5 P! W
• Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 11 days following injury " u% p. [( Q" b+ S• Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI % ?" ]2 G8 T$ r0 j4 m7 `Major Exclusion Criteria:' U3 K, L' P; l/ R. E# l
• SCI due to penetrating trauma ( X9 D& k* r5 R! O• Traumatic anatomical transection or laceration of the spinal cord " n$ o* z% P* L0 y: @. j9 P
• Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations ! \4 f$ A) T/ l2 e$ }) N& N$ O$ n+ n• Inability to communicate effectively with neurological examiner & q+ G- T8 e4 w$ c- q) A. Z• Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression $ B) \5 E; L& T2 \! Q• History of any malignancy $ B5 V( X* T1 S3 Q& z. H! F# L
• Pregnant or nursing women # [ \2 _4 P; Y6 D# \# g
• Body mass index (BMI) > 35 or weight > 300 lbs. 4 V4 o6 ~% m5 ^0 R
• Active participation in another experimental procedure/intervention ! \7 c+ w7 e6 w/ Y3 U& r3 ]/ S
Contacts and Locations% i' |8 r: [7 t: p' i
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217008: z0 m9 d& s( ~8 e. t
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Locations ) w3 v: Y8 P- k, Y8 a. `United States, Illinois 9 d4 ?( U9 d3 ~# k7 A# jNorthwestern University Recruiting ( L* C" M9 F+ b* p6 d* aChicago, Illinois, United States, 60611 * c# X& k Q* [' ~7 W# g" e4 E6 BContact: Narina Simonian 312-695-1607 n-simonian@northwestern.edu 6 Y7 g1 V8 H4 d; Y. f# ~ - u" y& c, f: n$ o8 l" }Principal Investigator: Richard G Fessler, MD, PhD 0 i# e5 p& h$ q8 I2 LSponsors and Collaborators2 V& ^8 i: M, h8 t% X' K5 p$ X8 ?
Geron Corporation ( b: S) l, X' f2 ~$ o- ~8 p# V l( t More Information 4 G. d+ q% f+ U$ D0 x5 ^% N9 E
1 W9 q: Z2 o6 \ f) s, TNo publications provided ' t; J4 x, k) i6 u1 V% p6 h
Responsible Party: Geron Corporation ( Regenerative Medicine Clinical Operations ) T5 p9 Y+ \. c$ v
ClinicalTrials.gov Identifier: NCT01217008 History of Changes . b& I6 R0 Q& ] 5 o. k! N' w1 }+ POther Study ID Numbers: CP35A007) [! T* P: m' n+ ?" T1 ]
Study First Received: October 6, 2010 7 u8 q2 d4 g- K* J0 ALast Updated: October 7, 2010 . Q5 v. A* ?- i6 k; z" @$ u3 mHealth Authority: United States: Food and Drug Administration 4 }: ?/ A/ \$ n9 b, q: p2 X- G& s- E
Keywords provided by Geron Corporation: - V3 o! W1 T9 QSpinal Cord Injury1 `: N0 P5 H0 K
GRNOPC1 & H3 A2 C+ {4 U5 J 9 F$ f8 X1 K7 t; r1 W1 gAdditional relevant MeSH terms: 9 Y" x1 R' |+ C: N& D# [" @# J. h
Spinal Cord Injuries3 k; `% L4 \5 B- V+ w! i2 @1 ^3 o
Spinal Cord Diseases; p! N: B; T5 D& M+ U F1 l' |
Central Nervous System Diseases% y( d* F7 V3 z: }
Nervous System Diseases Trauma, Nervous System- X. f4 q! F* ~' \1 r! k
Wounds and Injuries 8 t# D' c! U h9 p4 ^Disorders of Environmental Origin# h# Q1 v' @) y4 n- ]$ y
! H: C9 q4 _: k* x; jClinicalTrials.gov processed this record on January 23, 2011. O) S4 t1 Y& s4 Z6 ^" h( r/ V `