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Safety Study of GRNOPC1 in Spinal Cord Injury
9 m* w- {" w/ o YThis study is currently recruiting participants.
- w: i+ C" O0 `4 `4 ^+ k3 v& x* N' jVerified by Geron Corporation, October 20104 x) l1 v, y4 p* k2 S b ?
First Received: October 6, 2010 Last Updated: October 7, 2010 History of Changes
: K7 j+ }; P$ MSponsor: Geron Corporation 3 p, C& M: ]; Y& Q c Q% g) z
Information provided by: Geron Corporation
+ |$ @& Y6 {( m- t; T GClinicalTrials.gov Identifier: NCT01217008) x; E( h- V5 s2 T' k e; R( r
Purpose * c3 j2 X/ w, R
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).! n9 u% h7 Q% }. r1 w0 m: ^7 @/ i
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Condition 3 L5 j) E! X) b7 s. v% O* h: w
Intervention % A) S2 g* c$ ?% z) N; p7 j
Phase : H# S4 o/ D, N7 B
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Spinal Cord Injury Biological: GRNOPC1 Phase I/ D3 f3 }9 u [1 L
4 M- o! q! \) \/ DStudy Type: Interventional
$ W: z% Y7 ?5 S/ w0 e9 Y6 w) ~: R% OStudy Design: Allocation: Non-Randomized
. D& p/ M: z/ k" R! dControl: Uncontrolled6 `6 _' c w3 _# N) V* H) \
Endpoint Classification: Safety Study
" h9 n9 D- y/ E1 B# dIntervention Model: Single Group Assignment
5 w+ m. f. s6 D1 @+ O) OMasking: Open Label6 u+ p; i% i' h6 |3 j1 G
Primary Purpose: Treatment
5 |# p9 M5 V* D3 {5 }5 B7 vOfficial Title: A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury! N a P8 Z7 o& U
5 S7 k4 @- l+ P" j* R. _( X( e; T \Resource links provided by NLM:# o& O( x7 ?$ F5 [
7 g, M2 Q( h% n0 `) ~( u- \8 g1 IMedlinePlus related topics: Spinal Cord Injuries 9 ~( N: e& n* E7 T7 j
U.S. FDA Resources
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Further study details as provided by Geron Corporation:7 t% `+ ~' w) F) E. [+ R) A- k
) n' \5 A; `1 K& F- F4 h J1 nPrimary Outcome Measures:
1 f+ ?- C% ?. i3 T3 {4 m) X. m• Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
9 j4 V) B! d+ ^1 U7 {3 cThe 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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Secondary Outcome Measures: ! D, e/ p) T- H& d3 r' R
• Neurological function [ Time Frame: One year ] [ Designated as safety issue: Yes ] ' A! ?- M8 O4 F
The 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.
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Estimated Enrollment: 10
* ~' I1 p V! I' Y$ JStudy Start Date: October 2010
6 b! t# O; u4 x0 ` uEstimated Study Completion Date: October 2012
+ o6 D; I( g( q7 d! `2 J7 jEstimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
% B+ ?# t' m3 J BArms : B$ h+ J j! H* E
Assigned Interventions 5 ~/ d5 d8 a2 U# I9 ], ^4 Y( r
5 I0 `9 Z+ h* Q1 u/ J- v" cGRNOPC1: Experimental
; B9 L$ T. D1 b0 LSubjects who receive an injection of GRNOPC1; \1 v/ j7 N5 g2 I' C
Intervention: Biological: GRNOPC1 Biological: GRNOPC1 8 E, k9 j* a1 s( Y
One injection of 2 million GRNOPC1 cells.
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Eligibility6 L: u& @: }4 z$ O) Q) O8 e* B1 p
Ages Eligible for Study: 18 Years to 65 Years
- |! V X7 Y, t9 C3 n! OGenders Eligible for Study: Both
4 E- l; Z- g- S0 Z" ]$ W; I2 GAccepts Healthy Volunteers: No5 l2 u/ B5 v) R4 q
Criteria# w9 r/ ~2 i. P7 q0 f& r9 o
Major Inclusion Criteria:
9 W+ P9 h& X+ N• Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels ) i4 Z8 x& ~# @6 J2 [6 Q/ X$ O
• Last fully preserved neurological level from T-3 through T-10 7 X7 N) ^! K1 J
• From 18 through 65 years of age at time of injury " S6 {1 t7 D$ l9 u
• Single spinal cord lesion
* M' x! x* G: t1 m& j• 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
) e0 x! L) a9 P3 L• Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI & K$ u# g, o u
Major Exclusion Criteria:( }2 s! I6 J' }4 a( G _ L
• SCI due to penetrating trauma 6 x- g& \5 g( i6 u- |. |% h
• Traumatic anatomical transection or laceration of the spinal cord
^+ N6 j) `6 l1 }• Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations
; ]+ A5 S7 N0 K# Y9 _9 b( Y7 G* L• Inability to communicate effectively with neurological examiner
% Q6 \) Z0 P% n# p9 y" M9 ~1 Q \• Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
, N) e6 k) w1 \( Q• History of any malignancy
0 u A3 [( E; X5 c; z, f6 J• Pregnant or nursing women . X( X1 K2 h1 O7 }& D7 l j
• Body mass index (BMI) > 35 or weight > 300 lbs. 3 n) a& d) ^ R9 M, t
• Active participation in another experimental procedure/intervention
) v: {, n; ?' O7 e, ?4 J! f Contacts and Locations
[7 z; N% N2 [( lPlease refer to this study by its ClinicalTrials.gov identifier: NCT012170087 T: X0 d' [ R; A
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Locations% o/ O$ W; b7 U
United States, Illinois1 h. W, T! f* h7 L
Northwestern University Recruiting: p& I$ N* A8 X! ]
Chicago, Illinois, United States, 60611
. r! i% e& V. e6 Y* iContact: Narina Simonian 312-695-1607 n-simonian@northwestern.edu ! k6 c) k& j& N0 h9 c
: v9 P: |* }3 @ \Principal Investigator: Richard G Fessler, MD, PhD
5 m; `. Q7 F V7 v4 mSponsors and Collaborators$ `6 F- N/ X" {0 e4 G8 X
Geron Corporation
. m$ d c8 Z! `+ ] More Information 1 m( f) i& w; Z* P* T0 U* i
9 Q3 j( y6 b: o, e+ C; xNo publications provided - U6 V. L5 q0 u5 D
Responsible Party: Geron Corporation ( Regenerative Medicine Clinical Operations )
* P6 g' @4 O) p: l1 dClinicalTrials.gov Identifier: NCT01217008 History of Changes ; G$ D" {5 Y6 F0 j
' f) m8 T: d: ]. i# k' b8 @Other Study ID Numbers: CP35A007
3 v) w9 H; M- H5 H5 zStudy First Received: October 6, 2010& m$ @6 F/ \, A1 f: l
Last Updated: October 7, 2010# \6 u# m$ _$ M/ J C! i/ ~0 D
Health Authority: United States: Food and Drug Administration
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$ N0 D" i# B4 A; a2 L* ^7 u) W LKeywords provided by Geron Corporation:
, N- m. N/ \* B8 X/ \+ _( ?- P& jSpinal Cord Injury
) }/ s- W" X+ K% n! d uGRNOPC1! k, e5 u6 z9 _. f6 E; N
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Additional relevant MeSH terms: 1 R; J6 j7 V e
Spinal Cord Injuries; ?6 J+ Q& e$ P+ k; A
Spinal Cord Diseases
1 B2 b) k- z- D/ G5 _+ TCentral Nervous System Diseases* C6 p, o+ c; \4 N y5 B7 S4 r
Nervous System Diseases Trauma, Nervous System
" v6 F9 l7 f! P; J* RWounds and Injuries
1 {. w$ h: f( `" m; Q7 _Disorders of Environmental Origin
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, z' B, u0 j: X2 T$ q9 kClinicalTrials.gov processed this record on January 23, 20114 g: v4 e6 p1 u5 }# W
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发表于 2011-1-25 16:29
