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Safety Study of GRNOPC1 in Spinal Cord Injury
3 L3 H. ^2 N& U: o/ d' c7 m. BThis study is currently recruiting participants. ) N$ J! Y& k& _; F
Verified by Geron Corporation, October 2010
8 n) Q4 H0 |8 O% ^/ c& ]First Received: October 6, 2010 Last Updated: October 7, 2010 History of Changes
/ C) O' |, w7 b- p3 GSponsor: Geron Corporation
9 W" |' }0 i. n/ bInformation provided by: Geron Corporation6 ]9 {0 ^6 H/ O. g5 h" E
ClinicalTrials.gov Identifier: NCT012170088 X. R$ t; y& B' O3 ?* Q
Purpose 4 V+ ~ U9 P* g7 i" y% c- ^, i
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).
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Condition
/ y2 f: a) w5 T! a MIntervention
/ {: e, I, L. rPhase
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Spinal Cord Injury Biological: GRNOPC1 Phase I# q0 N$ i( O0 `' |
1 W, X1 n8 @6 ^9 y$ S- m% DStudy Type: Interventional
' i7 y' Z, [( r" W! QStudy Design: Allocation: Non-Randomized y) r% E7 S3 ] d
Control: Uncontrolled
4 s4 K( q1 b9 x$ ZEndpoint Classification: Safety Study' g2 Q( Y3 H- m% N: i
Intervention Model: Single Group Assignment* q+ {4 V& |7 \+ T
Masking: Open Label
" X5 `$ u0 _# n" `' M4 A# H8 RPrimary Purpose: Treatment* G" _: c8 a$ T- `$ y
Official Title: A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury, J7 ^# z+ g1 n& Y9 k) G+ r
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Resource links provided by NLM:* O0 b/ |; L3 V. K( g% s+ N# L
3 ~6 s. W+ I( w) @! Z0 s, LMedlinePlus related topics: Spinal Cord Injuries ) C% y! q2 g5 i& e0 T
U.S. FDA Resources
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Further study details as provided by Geron Corporation:3 [9 C2 q( X; L( w6 o: Z3 K
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Primary Outcome Measures: , w- b% [& ?3 `0 j
• Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
, H2 Q1 |1 Q2 r( e; M+ QThe 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.
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/ E" G, O d) i% d5 ?Secondary Outcome Measures: 5 B( V Y% u$ L$ N- a
• Neurological function [ Time Frame: One year ] [ Designated as safety issue: Yes ]
1 Q) }7 X- @/ T5 R aThe 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.6 _5 x) T$ t a& l: @
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- G: w0 e1 H$ v/ q! q& [& BEstimated Enrollment: 10: t( c" l6 ^1 R' B6 Y0 ~ B
Study Start Date: October 20103 |& d0 l1 {' h) d
Estimated Study Completion Date: October 20125 k6 N" B' q6 C
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)+ X1 \: ^% ~4 q) G- E
Arms
8 I; e% Q" O: V6 Q4 ~0 v# d1 }' P/ LAssigned Interventions - |* F+ r8 W7 [7 c
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GRNOPC1: Experimental D) z" F0 ~; I" B1 t" p
Subjects who receive an injection of GRNOPC1/ Q$ A( L: k# X+ x$ D
Intervention: Biological: GRNOPC1 Biological: GRNOPC1 6 ]* G4 c1 c; C9 e4 R5 }
One injection of 2 million GRNOPC1 cells.0 E6 ?$ X( s8 J, |
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" z- T3 _; b3 S& _4 _- J Eligibility
1 [% V& W$ G: `" T. E3 gAges Eligible for Study: 18 Years to 65 Years
5 D# N/ Q! @8 Z' R: ]Genders Eligible for Study: Both3 Q3 V8 j% T$ A' Y, U
Accepts Healthy Volunteers: No9 s% h) ?- L9 w$ ?1 ]! t
Criteria9 [) }# {4 q5 u) s1 @+ E/ C
Major Inclusion Criteria:
8 K" A( h3 w+ A$ A8 j• Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels ! X% I: ?! e: ^5 O9 ?
• Last fully preserved neurological level from T-3 through T-10 e2 V0 b0 R6 J4 E/ V
• From 18 through 65 years of age at time of injury
; L' i) J1 x; ?" Y+ G5 B9 `• Single spinal cord lesion
' [9 i% ~* G( X9 F& z9 H( e• 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 2 @; G& |( I/ a8 ^6 |% q
• Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI
' c- [9 y4 B$ c# N' |$ S% kMajor Exclusion Criteria:$ S3 }4 }6 z6 p4 B7 y
• SCI due to penetrating trauma $ w& N) Z- U6 `% O( M; t( M
• Traumatic anatomical transection or laceration of the spinal cord
9 m* T: D' y- v. L' D7 G2 C• Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations
" q+ u3 o# |9 `• Inability to communicate effectively with neurological examiner 4 r- F9 j0 Y2 e; h4 i: s
• Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
! [ \! x5 t; ^• History of any malignancy
% P6 C3 T, a) l% T4 A! t& g* s• Pregnant or nursing women
8 h" V* D6 H7 X# J; q; m) q• Body mass index (BMI) > 35 or weight > 300 lbs. % w1 V& Z z6 y% f
• Active participation in another experimental procedure/intervention 4 F. k% r! V/ R# {
Contacts and Locations
7 h% ?8 V0 R& s& _Please refer to this study by its ClinicalTrials.gov identifier: NCT01217008
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r8 L4 q5 M3 n& ?Locations% o9 l |7 b2 h) `. q% G7 o
United States, Illinois
! W! O* q: M# p/ XNorthwestern University Recruiting
_/ o( N( c+ G6 z* \( K3 s: cChicago, Illinois, United States, 60611 8 D! i5 J7 e( ^2 ?
Contact: Narina Simonian 312-695-1607 n-simonian@northwestern.edu " j8 E5 e- P9 ?( c1 ]6 y$ q
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Principal Investigator: Richard G Fessler, MD, PhD ) T% [: `- G/ T. d4 c
Sponsors and Collaborators
% B9 q6 J9 o0 w3 c* \Geron Corporation7 ]. `$ ^6 Q# T/ C2 d
More Information
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! \( s4 a4 M& g, [& u+ e; m1 T) f3 yNo publications provided - k8 E" E! p @0 W1 A
Responsible Party: Geron Corporation ( Regenerative Medicine Clinical Operations )2 @( @; k& r) t+ l* g2 V: X
ClinicalTrials.gov Identifier: NCT01217008 History of Changes : U, P- L& { j, g" F# T" P
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Other Study ID Numbers: CP35A007
" V3 k0 k# ~& ]$ R9 q' N, ]* P3 UStudy First Received: October 6, 2010
2 j; t! A1 I) N9 E+ s! oLast Updated: October 7, 2010
( A7 [/ ~* ?9 @% }! p1 i/ DHealth Authority: United States: Food and Drug Administration
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Keywords provided by Geron Corporation: p" ?0 B$ f% q' W
Spinal Cord Injury# o3 ^% h! Z$ d* L- A
GRNOPC1
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Additional relevant MeSH terms:
2 X9 T) ^2 h; j/ ?4 |Spinal Cord Injuries3 p8 P' L# K. W
Spinal Cord Diseases4 j7 Z2 J# Q% {
Central Nervous System Diseases
; e: P/ F5 g# v5 u0 p$ eNervous System Diseases Trauma, Nervous System
( }: n9 M5 h( a$ W# ?/ uWounds and Injuries* A c+ O/ F; ?( A/ U T* H( k
Disorders of Environmental Origin
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& x, l4 o2 q: q& g& zClinicalTrials.gov processed this record on January 23, 2011
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发表于 2011-1-25 16:29
