GRNOPC1治疗脊髓损伤安全性研究临床试验

botizhou

Safety Study of GRNOPC1 in Spinal Cord Injury7 V- A+ H9 ~9 ]/ W# S
This study is currently recruiting participants. ; W& s; q. @3 c! p' |# ~
Verified by Geron Corporation, October 20102 f$ Q! l1 Z4 P+ n
First Received: October 6, 2010   Last Updated: October 7, 2010   History of Changes
$ P, G0 j4 D! f/ s+ k( zSponsor:         Geron Corporation - @8 Q" e. {( d( b
Information provided by:         Geron Corporation
, X% }8 z- g9 y9 pClinicalTrials.gov Identifier:         NCT01217008
8 t; s; x" l7 ^! l, w   Purpose 0 Z& S0 d+ T6 G- ?# n
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).
1 Y- n3 h2 F7 k5 }! w! K6 Q
, e) G6 ?# [+ N$ b, P$ Q5 _. s1 P  I0 Y: v9 V
Condition
/ j8 g" U, N* g4 _$ i/ DIntervention
* x% R  N) i! a& Y8 tPhase
3 l' b( A  J2 p4 m
" l. ]9 b( c8 O- Z' C- D! U* ZSpinal Cord Injury        Biological: GRNOPC1        Phase I3 B  G% W* _+ i! |1 G8 C3 d. [

0 u6 |6 e2 |2 D! V/ \+ nStudy Type:        Interventional
) z. @: X8 H! OStudy Design:        Allocation: Non-Randomized
, U7 ~' Z3 i# J. Y. |; E7 wControl: Uncontrolled
. `3 b& j7 Y( q- n9 k3 \$ Z* s- |2 XEndpoint Classification: Safety Study
: f- G3 p& y  C  h# R  vIntervention Model: Single Group Assignment6 _0 ~# M1 _; s+ q: W! z- ^. [
Masking: Open Label4 y5 s6 b0 u9 o
Primary Purpose: Treatment
1 U  }. `4 |3 u0 C4 d2 gOfficial Title:        A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury
7 e0 L0 U. c, \( A" S: s  h5 R0 s* c: \% P2 y% F) B$ `) Z* Q! |
Resource links provided by NLM:$ x8 ~" k- q7 V+ k" ]4 V8 J

3 }, J5 Y; {6 d) gMedlinePlus related topics: Spinal Cord Injuries
/ ?8 q  O% o2 P: P' p5 l+ iU.S. FDA Resources
/ X$ `$ U( ^' f. x3 D3 r. _0 ~9 h5 l6 N; J: H
Further study details as provided by Geron Corporation:
  C' b6 X7 d5 ?; N- o5 K) F
$ O: m3 ?: ~$ z$ w( g7 F7 ePrimary Outcome Measures: 3 v: n: J/ H; q; |* _2 u( `: ~. H
•        Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ] / E( O1 {, Y: r% l1 X% E' c# n, w
The 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.
2 I1 V/ h; n# m8 ^7 I8 p  [0 W, ^0 E: P' o: i# f
$ v5 o7 s0 A% p0 Q$ Q* A

" g8 j1 K) O  w. J8 l: f- O  ^Secondary Outcome Measures: $ v  Z3 r1 e0 A  `, H
•        Neurological function [ Time Frame: One year ] [ Designated as safety issue: Yes ] / Q" M9 P- f3 ^; g
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.4 K& T; x9 P. [, b4 `
! E: C$ y' Z* H# v  B" Y

* o' I5 P) ?- @- Q+ d. L, H. ~& UEstimated Enrollment:        10
9 j1 O) R$ E$ }7 q% ?& i/ [Study Start Date:        October 20106 |( a, w1 `$ m% n2 Z9 ?
Estimated Study Completion Date:        October 2012. i3 O& N* Y, r9 _
Estimated Primary Completion Date:        October 2012 (Final data collection date for primary outcome measure)
' ?/ E0 F- w0 w" Z; W+ IArms
7 Y  S3 }& S9 k: N3 XAssigned Interventions 8 _8 R# n' R$ x

; D6 e9 ]8 F% [+ F9 qGRNOPC1: Experimental
$ F1 ]$ U4 [/ E2 @: c7 hSubjects who receive an injection of GRNOPC1" ~2 I& ]5 F) F/ E7 t
Intervention: Biological: GRNOPC1        Biological: GRNOPC1
& @; c7 x) L6 p+ n" XOne injection of 2 million GRNOPC1 cells.. D* ^* R" F8 d) C( ~* `
, K. J0 B  u; X1 O+ c% I$ A+ s
, a1 s0 j# ]" G- R( g
   Eligibility
* D& r7 ]8 s5 M6 o) |. G6 W, QAges Eligible for Study:           18 Years to 65 Years% G& c% N7 l% ?7 [
Genders Eligible for Study:           Both
# e/ y. m3 v; `! lAccepts Healthy Volunteers:           No
2 ~2 G6 f$ N" ~/ P/ V& Z2 cCriteria
# ~! z8 D# q; b2 I: @; CMajor Inclusion Criteria:
5 E8 r6 F- r$ F2 X•        Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels
9 r0 u; j, W+ [; [2 u: |) s( @•        Last fully preserved neurological level from T-3 through T-10 $ o: n( s$ J5 Q- H8 n, L& ?
•        From 18 through 65 years of age at time of injury
# _3 V5 g3 W+ C; O, t8 z( Y•        Single spinal cord lesion   ]: O8 q* A* x* |9 L6 c
•        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
7 G% r4 x6 g2 D  a/ J  |- u  p•        Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI : J& W, z+ w7 f4 i. Z8 Z
Major Exclusion Criteria:; E9 R" ]& J" p
•        SCI due to penetrating trauma 9 y# Z, \; y) H& [/ C: F5 g
•        Traumatic anatomical transection or laceration of the spinal cord
( Z% G2 Z. s! M•        Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations " W3 S, I* T1 T$ q6 j- V. Z# X3 V# T
•        Inability to communicate effectively with neurological examiner
) a' q; W4 ^6 Q% Q% B( m" Q•        Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
0 T7 I- x  V) m•        History of any malignancy 9 ^) E7 a7 K) x( H# q5 {* A7 W
•        Pregnant or nursing women
7 y3 ^4 N& N; e/ k. J•        Body mass index (BMI) > 35 or weight > 300 lbs. # B. j0 v9 `" j. D1 T. [
•        Active participation in another experimental procedure/intervention ) T3 p5 \, q- e/ }' h3 e4 a
   Contacts and Locations; h6 H6 o8 b# H( Z' v; P+ v
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217008, B4 m( l; m6 _% [1 I" ~+ D

4 x3 D: T: D! `( R3 k+ t( N1 Q6 B7 T9 @9 }5 b* b, W0 v/ B
Locations# N/ I: ]$ H/ Z* Z
United States, Illinois
: g+ J- U$ C' ?Northwestern University        Recruiting
. c) F" T, v8 EChicago, Illinois, United States, 60611 - ^& X0 k" S/ S$ Y0 I
Contact: Narina Simonian     312-695-1607     n-simonian@northwestern.edu     
' B6 y# ^' C# X4 y2 m8 R5 h$ c$ n0 R8 z& o' D6 o
Principal Investigator: Richard G Fessler, MD, PhD             % a, X: Z: L7 @. U: l( S
Sponsors and Collaborators9 i, {1 v0 }* U5 b* b. u
Geron Corporation" Y$ f1 k& g" U0 }
   More Information
( V6 A% h: r  {9 @. B
! J4 z$ l- ~" C" K( ~No publications provided ( n# n9 c! F2 I5 \# H& e. Z( {
Responsible Party:        Geron Corporation ( Regenerative Medicine Clinical Operations )6 t% i* A$ y1 C; n
ClinicalTrials.gov Identifier:        NCT01217008     History of Changes
) y- b# P4 j. D' \* |. A
5 ^# r/ @  Y1 W# c& bOther Study ID Numbers:        CP35A007
, z+ J$ X3 j( [; W$ mStudy First Received:        October 6, 2010
# L6 I# ^$ y( ^  N/ uLast Updated:        October 7, 2010" A1 ?) I  E" t8 d. ~
Health Authority:        United States: Food and Drug Administration% H# H/ K0 b3 w5 m$ k/ j

3 P& h( I, D/ ?9 RKeywords provided by Geron Corporation:
$ X. O3 M/ ]: S0 @) N: u+ dSpinal Cord Injury
% o. i7 _1 q; Z1 c9 f& HGRNOPC12 l" q0 S, i5 M# _- E1 V9 p
1 X2 ^: w9 L. J  f- _0 W2 o2 A
Additional relevant MeSH terms:
  k5 C4 ~) `% `) ]8 Z2 i4 MSpinal Cord Injuries
4 d* y, O9 J) E* e/ kSpinal Cord Diseases
: O5 q2 l7 G8 ]) n# R3 b( nCentral Nervous System Diseases
- t. C7 ?3 k& o- p& @1 [- pNervous System Diseases        Trauma, Nervous System
6 ^5 H8 h7 p4 v1 `8 J# v9 BWounds and Injuries5 F' R6 _3 G. _! |
Disorders of Environmental Origin
; a8 z% y& f$ j. h# w$ Q5 a
, V. X( p0 l# e* c: Q7 ]ClinicalTrials.gov processed this record on January 23, 2011
) {2 l8 x( F7 W( N
+ A$ U7 f* a* A8 ?4 K

123456zsz

我的妈呀，爱死你了  

foxok

这个贴不错！！！！！  

biobio

应该加分  

foxok

楼主good  

石头111

干细胞研究还要面向临床

awen

很有吸引力  

舒思

谢谢分享  

MIYAGI

好啊，谢楼主

榴榴莲

世界上那些最容易的事情中，拖延时间最不费力。