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A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke; ^/ D' U& |7 \6 d C% n( b6 {
This study is currently recruiting participants.
2 i3 E* |& E2 s+ }4 I% R8 v0 bVerified by Stemedica Cell Technologies, Inc., February 2011
9 R; p, Q6 q$ n5 _4 n2 QFirst Received: February 10, 2011 Last Updated: February 15, 2011 History of Changes
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! \% \2 U7 p6 M$ X$ E) VSponsor: Stemedica Cell Technologies, Inc. ( [, L* i' o9 z. n) ^
Collaborator: University of California, San Diego
2 s5 y4 T# c: rInformation provided by: Stemedica Cell Technologies, Inc.
1 i1 [; q6 Q+ r6 Z. }6 EClinicalTrials.gov Identifier: NCT012974139 ]4 a5 j1 {; w3 X2 s/ z' \
Purpose
) j9 X4 c8 e+ x- g( A- i. @6 EThe purpose of this study is to assess the safety and tolerability of allogeneic adult mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.6 u6 ^, Q' H, d9 D5 u6 X
Condition 7 r+ F: J: B( ~5 p. f" w2 e' a! ?
Intervention $ m& ]+ x, _2 l4 O* T
Phase ; l# M) X2 S; j S4 O8 Q
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Ischemic Stroke Biological: Allogeneic adult mesenchymal bone marrow stem cells Phase I) m# o* l& E* w1 Z' B/ n
Phase II( g- L+ n7 F2 S9 T( L
) O$ Q0 x- \& }Study Type: 7 g/ v+ Z+ H! ~
Interventional
' R" h+ f' m' p% D" c2 {Study Design: Allocation:Non-Randomized
* \, [( b" J% a8 y! g: A7 m, MControl:Uncontrolled
! B. c" R, a$ ?& B5 p* ?6 \7 MEndpoint Classification:Safety/Efficacy Study
. z& X" [$ B: MIntervention Model:Single Group Assignment L) V2 W8 f$ k; q/ }# h
Masking:Open Label
; n& _' ~! \+ yPrimary Purpose:Treatment
$ H% M3 _7 `4 ~: COfficial Title: A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke' y( R. p7 _$ _. L3 S) z5 _8 w
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Further study details as provided by Stemedica Cell Technologies, Inc.:
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Primary Outcome Measures:
# E: I' r0 @' K* R1 z• The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period. [Time Frame:12 month] [Designated as safety issue:Yes] 9 Q: P4 k3 D. p9 {9 G
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations.
6 `9 `$ h" A. e! l2 |, d7 lSecondary Outcome Measures:
4 y8 G3 u, W! [* s" m: l$ H• National Institutes of Health Stroke Scale Score. [Time Frame:12 months] [Designated as safety issue:Yes]
8 ]4 L* v, `& G# W! _The change from the baseline in National Institutes of Health Stroke Scale score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available:2 C$ w5 H) Z9 q' }8 @. |
• Mini Mental Status Exam score. [Time Frame:12 month] [Designated as safety issue:Yes]
2 P9 B0 Y) w- w, j( v8 v) e0 OThe change from the baseline in Mini Mental Status Exam score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available.# \% E- V( J8 j6 Y
• Barthel Index Score. [Time Frame:12 month] [Designated as safety issue:Yes]
& C! s* ^0 K3 t" Z' Z" a; jThe change from the baseline in Barthel Index score at 1, 3, 6, 9, 12 months post-treatment, as available.
* U7 o' S& q3 c# f8 T• The Geriatric Depression Scale Score. [Time Frame:12 month] [Designated as safety issue:Yes] s, s: q! t" _+ Q4 j K3 g
The change from baseline in the Geriatric Depression Scale score at 1, 3, 6, 9, 12 months post-treatment, as available.
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2 W9 i- `; F& G0 @5 WEstimated Enrollment: 35/ s2 P" ~1 |8 Y$ X( D+ ]' o4 ]+ }
Study Start Date: February 2011: L; w1 `( T) r) _# m7 r
Estimated Study Completion Date: February 2013
) `* R3 @6 ?8 T, J/ N/ q+ X1 WEstimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure); r2 f {( P8 Q' s, [8 N
Arms
! P1 z/ l( e6 |/ w. E3 eAssigned Interventions / Z; x; Z" }4 q; P$ j
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Stem cells: Experimental
& {" V8 C4 O( k* S" h* a' Y7 VAll subjects will receive allogeneic adult mesenchymal bone marrow stem cells( h* f' V6 C* a2 ^
Intervention: Biological: Allogeneic adult mesenchymal bone marrow stem cells Biological: Allogeneic adult mesenchymal bone marrow stem cells ) j+ K) ?- j5 |5 n: v
Patients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells# p/ q3 ~- M" F0 l
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Detailed Description: % x% [7 y0 u1 W. u' K; f3 H4 B+ V; w
Stroke remains a major global healthcare problem. Recent data compiled by the American Heart Association (AHA) for 2008 show that the annual incidence of new or recurrent stroke in the United States is about 780,000, with approximately 600,000 of these strokes being first attacks. Among adults age 20 and older, the estimated prevalence of stroke in 2005 was 5.8 million in the United States, resulting in >150,000 deaths annually, with 4.8 million stroke survivors alive today. Stroke ranks as the country's third leading cause of death, behind only cancer and heart disease. The only approved treatments of acute ischemic stroke involve restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy. Following the completion of a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy.( N5 E) Z, V3 H! T: S( R3 a
Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications demonstrated the safety of allogeneic mesenchymal stem cell treatment. In addition to their ability to differentiate into multiple different cell types that would be contributory to the recovery and repair of the brain by replacing destroyed cells, mesenchymal stem cells also secrete angiogenins, cytokines and trophic factors that can support and stimulate multiple other cell types. The cascade of cellular events following the release of these cytokines and trophic factors would also potentially lead to beneficial effects by restoring blood supply, by rescuing cells at risk, and by stimulating the remaining cell populations to repair and propagate new cells and synaptic connections.
2 O* h0 y" ?1 \( {$ n3 n' j1 H Eligibility8 u2 x" R: z3 K
Ages Eligible for Study: 18 Years and older
- q, R L/ l# M) S" M' iGenders Eligible for Study: Both
0 X9 h' l' F* K+ gAccepts Healthy Volunteers: No
1 q: x; ], M# }9 _, \9 vCriteria
8 \- \8 Z# ~: G% kInclusion Criteria:
8 }( r# Z+ c5 l1 y% B" B• Clinical diagnosis of ischemic stroke for longer than 6 months
1 D* C: Y* q& Y' ` |• Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
( {; @: h6 ]% q$ o1 V3 d$ `• No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
D7 U7 k& c/ }. E0 L• NIHSS score between 6-20
* `$ Q% V, s# N. x• Life expectancy greater than 12 months
2 q; k. a7 w# f) a% n• Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke 5 {* q9 H" q7 l5 O
• Adequate organ function as defined by the following criteria:
7 ? g/ z) m4 g+ e2 GExclusion Criteria:
: c3 F# T! e/ B+ D/ z, z0 g( l• History of uncontrolled seizure disorder
$ ^, b) y0 E) X: ?! b! K• History of cancer within the past 5 years. 2 k! h( Z7 T& v" V' S8 {& n
• History of cerebral neoplasm 0 D4 ~( o3 G8 S4 ^* g6 ~
• Positive for hepatitis B, C or HIV
Q6 D4 q& A+ t6 r• Myocardial infarction withing six months of study entry ' ~' V" b+ {) j5 z- p% x
• Findings on baseline CT suggestive of subarachnoid or intracerebral hemorrhage within past 12 months.
7 u' q- p" D: _/ Q! x% X1 m! X• Allergies to Bovine or Porcine products 6 P% ~4 O+ ]' d" Q
Contacts and Locations
2 z: l' q& X9 EPlease refer to this study by its ClinicalTrials.gov identifier: NCT01297413
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$ n6 V& r' @, Z5 M# p$ |Contacts/ {8 e7 H5 W5 w! c( X
Contact: Michael L Levy, MD, PhD FACS 858-966-8574
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0 H0 {+ u" B9 l8 yLocations
. |' o/ G3 R; W. y- {United States, California7 ~% p: e, @9 ?3 [# a+ b$ Q
University of California San Diego Division of Neurological Surgery Recruiting9 x" I- \& t+ s) V5 K$ W) @
San Diego, California, United States, 92123 9 N6 c/ [2 D4 x; u2 N# c* c
Contact: Michael L Levy, MD, PhD FACS 858-966-8574
; Z2 o! M1 i1 I6 x3 u. ?9 PPrincipal Investigator: Michael L Levy, MD, PhD FACS
* G( W; _$ ?: R# p$ |* _% {2 j& J4 sSponsors and Collaborators3 ?. n/ r9 G# ^* k3 x
Stemedica Cell Technologies, Inc.
1 }% w0 U- I/ ]0 `University of California, San Diego
2 h% m- x- M$ B. e) ]Investigators
r: f6 D1 f" w& K1 t, mStudy Director: Lev Verkh, PhD Stemedica Cell Technologies, Inc.
+ b' m4 s7 N3 w: H More Information ; i$ m) k/ J( r, Z: Z! o
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No publications provided 1 X6 w: Y; }! H. P3 R
Responsible Party: Stemedica Cell Technologies, Inc. ( Lev Verkh, PhD Chief Regulatory & Clinical Development Officer )- S0 J( I* l7 P% D8 ^6 f% B6 d6 a1 V
ClinicalTrials.gov Identifier: NCT01297413 History of Changes . e0 g/ u3 J" I6 K& e
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Other Study ID Numbers: STEM 101-M( @9 |( i9 p$ }! H
Study First Received: February 10, 2011% L2 U% K- B, n( w K
Last Updated: February 15, 2011
( Y) I# f- }/ FHealth Authority: United States: Food and Drug Administration1 C4 b, o# V# B( Z K
3 L' H. i0 f5 j& o5 L8 ?( f4 mKeywords provided by Stemedica Cell Technologies, Inc.: 4 t& o* A$ D5 g: k& r! m. B
Allogeneic adult stem cells ischemic stroke 1 t' P# O/ Z5 n _" t8 O8 t, G
1 n# N% P" E+ L) M8 z2 Z kAdditional relevant MeSH terms:
! d, H/ N. {0 Y' Q% fIschemia/ I7 w; {) f `+ L/ N/ P H \$ I
Stroke1 Y% b) b. h4 t9 v& r
Cerebral Infarction
+ z$ g& e( Y# l2 H5 ?8 S$ IPathologic Processes
- S& W: y: M7 M& k5 V9 \/ c- H3 qCerebrovascular Disorders+ v+ \' B5 s% g- h- Z
Brain Diseases Central Nervous System Diseases
F% P; E5 \5 |# t$ ^/ P: HNervous System Diseases* Q/ E+ l! l. X/ R9 o/ y5 P6 W
Vascular Diseases
/ r# ~4 V; n' {8 B% o5 o$ x6 B1 dCardiovascular Diseases
( P4 |/ o! g$ D5 W2 n0 bBrain Infarction
6 K5 ^; e% ^ r% qBrain Ischemia. [# Z2 F! p ~9 J
0 C, U* G2 B$ V. y4 X; f4 {& HClinicalTrials.gov processed this record on February 28, 2011
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发表于 2011-3-4 16:30
