GRNOPC1治疗脊髓损伤安全性研究临床试验

botizhou

Safety Study of GRNOPC1 in Spinal Cord Injury1 _7 o* [! e3 |4 R( m; d) b
This study is currently recruiting participants.   w- E- }9 l, [% ]
Verified by Geron Corporation, October 20106 K* [9 [; }+ ^) Y( E
First Received: October 6, 2010   Last Updated: October 7, 2010   History of Changes
$ L" D, ~7 D) g9 v* ^Sponsor:         Geron Corporation
& J5 ~/ X' H# D; o5 pInformation provided by:         Geron Corporation
/ m! j2 t% ?0 C2 r& l- g1 Q. d/ eClinicalTrials.gov Identifier:         NCT012170088 W9 z  c' U# W/ f( p
   Purpose
3 g/ [5 d. w2 B0 f: hThe 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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; ]; a1 w& C* @Condition 1 i# F% t4 @" g# G
Intervention + R8 x7 d7 S+ A. F0 U
Phase 9 z* W3 I6 O' z/ ~- W

; k% ~' L& l+ Z; H0 KSpinal Cord Injury        Biological: GRNOPC1        Phase I$ {' U) k+ Q: t& \, ]) I) q( P" ^

4 [1 D7 B$ H8 |Study Type:        Interventional   D: P: `& ]: n$ j3 I& O
Study Design:        Allocation: Non-Randomized
: C3 {: h$ l0 N' n& Q7 `: ]3 m4 VControl: Uncontrolled) R' t+ H9 G) X, ?4 l* G
Endpoint Classification: Safety Study6 `8 o5 p: `3 t/ g: k; b* f# N
Intervention Model: Single Group Assignment
( g+ D8 ]& F; m: }9 j9 KMasking: Open Label
  V( m& @- y- g6 J2 w) @0 t) SPrimary Purpose: Treatment  u/ \; a, A( ]
Official Title:        A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury% U) _! ?- d  Z7 I2 N" D

$ q: [" z/ v$ r. Z1 H8 DResource links provided by NLM:  q/ f; x: A8 `+ }

* @" P' I5 {% t6 H- b+ PMedlinePlus related topics: Spinal Cord Injuries
4 [6 U7 r) D+ UU.S. FDA Resources 0 H/ i/ t$ n  W# U7 V, D5 s6 O; H
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Further study details as provided by Geron Corporation:
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Primary Outcome Measures: & j9 ~- m- [3 n( m
•        Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
' z0 H% l3 H& J( ZThe 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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4 g3 a7 \1 _7 Y( JSecondary Outcome Measures: # e) P( V# D, ^5 l% U. l8 X: M
•        Neurological function [ Time Frame: One year ] [ Designated as safety issue: Yes ] $ P& T1 p0 o- J3 ]3 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.
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Estimated Enrollment:        10
1 J1 J) |+ @/ GStudy Start Date:        October 2010
0 A0 O( E- Y% s* M7 Z( @Estimated Study Completion Date:        October 2012
/ j/ {7 V) \1 R) LEstimated Primary Completion Date:        October 2012 (Final data collection date for primary outcome measure): ]- f5 L4 r8 W% n( a( Y
Arms
  R6 J) e2 u8 j  vAssigned Interventions
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GRNOPC1: Experimental
  Q9 c+ p: V& k0 |. U3 wSubjects who receive an injection of GRNOPC1# B2 Z( x. T# Q: f
Intervention: Biological: GRNOPC1        Biological: GRNOPC1
, d  m- H! T9 y, VOne injection of 2 million GRNOPC1 cells.
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0 p; Q6 N* P  ~; f: o   Eligibility
9 D7 v- c/ x. y6 v- \Ages Eligible for Study:           18 Years to 65 Years
# p. s: R: X6 c& _4 [- @) Z) MGenders Eligible for Study:           Both  L& F" H! E4 ]2 a
Accepts Healthy Volunteers:           No3 U+ o/ W5 T$ w2 N
Criteria
2 ?) s4 v" S/ K, g7 ~+ ^- q) \$ RMajor Inclusion Criteria:6 d* P5 j* Q: U7 O
•        Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels
; a9 M% n% `1 {) O- d) S•        Last fully preserved neurological level from T-3 through T-10 ) l1 {2 L  N' X( ?
•        From 18 through 65 years of age at time of injury " S" D& t2 Q9 R7 z
•        Single spinal cord lesion
$ s0 l/ b3 D$ R8 s3 X) r1 P1 ?1 i•        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 K% e" q( ^* \5 X- ]9 i•        Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI
( b6 r- h$ C8 W/ oMajor Exclusion Criteria:5 H% v3 T/ J1 ^7 @
•        SCI due to penetrating trauma
! E1 S9 }4 C! {. \% m; U  s1 ^•        Traumatic anatomical transection or laceration of the spinal cord : P% b' M" n4 \3 U4 e
•        Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations 2 Z0 ~  e: }$ |3 Y
•        Inability to communicate effectively with neurological examiner
8 t0 z; U% w! V0 r5 R•        Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
2 ?4 t* k% F  a5 R9 D& P+ n•        History of any malignancy
  K3 ~. H0 i, R* }- W: ?•        Pregnant or nursing women ( k7 w: A3 m9 ?7 P# Z
•        Body mass index (BMI) > 35 or weight > 300 lbs. # e# F  i) F* C4 \$ u/ K  ]9 b
•        Active participation in another experimental procedure/intervention 8 k3 [' W7 c8 e% ]$ E7 n$ @' U" m
   Contacts and Locations' }* P7 R% g2 Y1 [! H& s
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217008
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Locations
/ s$ @6 o; H  K  w+ t( ZUnited States, Illinois0 z$ y; k$ d) D- b; n3 j, m
Northwestern University        Recruiting- S/ L7 Z2 C% C/ G
Chicago, Illinois, United States, 60611 " i& V. U" t2 ?' z. g: G
Contact: Narina Simonian     312-695-1607     n-simonian@northwestern.edu     ' O% t2 x  ?: J4 f* _: B# m

# K3 f, W9 p$ l! Z4 Q) M+ X: i; jPrincipal Investigator: Richard G Fessler, MD, PhD             % I+ P( ?: K9 `, @& D& S' r: y
Sponsors and Collaborators
7 V+ g2 w, K+ O5 S; }3 N! t: ?5 N1 DGeron Corporation; ~/ b. j6 h. g) [* ]7 M
   More Information
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No publications provided + r9 X1 B+ M/ i8 Y6 K1 n0 m! s7 I: X
Responsible Party:        Geron Corporation ( Regenerative Medicine Clinical Operations )  a) T6 N, D$ W5 ?
ClinicalTrials.gov Identifier:        NCT01217008     History of Changes 7 V5 n# Q0 r$ @4 D# L. s  c: D

* z3 q# B+ a- }Other Study ID Numbers:        CP35A0074 h! l2 W/ n  d' ^! r1 }% T
Study First Received:        October 6, 20109 T% e& T6 E4 L/ [7 y6 q8 I3 U( e' G
Last Updated:        October 7, 20102 D7 X3 s/ G# D% i7 _. N
Health Authority:        United States: Food and Drug Administration
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$ C$ [8 A8 Y0 j7 q. D3 PKeywords provided by Geron Corporation: ' q8 g* ^$ {8 |, U
Spinal Cord Injury5 w) @* f- t% [2 {( ]
GRNOPC1+ M" A0 B; h) X
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Additional relevant MeSH terms:
0 j7 x. e5 B' G7 W  p$ ESpinal Cord Injuries. U- N/ O/ t: n0 c( e5 K* F) k
Spinal Cord Diseases
$ H& k# X5 O+ s6 g% UCentral Nervous System Diseases2 O8 E  I5 g7 d) E/ n$ R2 q
Nervous System Diseases        Trauma, Nervous System. P/ ]5 I- k0 M- Y8 }- W
Wounds and Injuries
& v+ o% g$ }6 b( A# gDisorders of Environmental Origin5 Q, ~" M& |4 q" Q2 `1 v+ H  s4 v
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ClinicalTrials.gov processed this record on January 23, 2011
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123456zsz

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foxok

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biobio

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foxok

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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。