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A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke2 Y; l: V4 P0 H( M0 I0 q
This study is currently recruiting participants.
+ }, [4 `5 `4 r% j" d* @Verified by Stemedica Cell Technologies, Inc., February 2011
, G& k' D$ m5 I+ j4 N+ f1 LFirst Received: February 10, 2011 Last Updated: February 15, 2011 History of Changes C/ ?- m6 K& L2 W( l+ M
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Sponsor: Stemedica Cell Technologies, Inc.
2 i7 z& A* D4 l3 G6 UCollaborator: University of California, San Diego( I- Y* Z! ^. y. c- a- |
Information provided by: Stemedica Cell Technologies, Inc.
! G- A* Y" V3 R/ e/ e3 kClinicalTrials.gov Identifier: NCT01297413% j& o& ~: T4 w) o; H
Purpose
3 F; I# B. k* h, I( Z$ WThe 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.( E- ?6 ^# m( q, K7 ]
Condition
/ i5 c% K8 f. ]6 j# mIntervention
8 M1 `1 W% l/ A2 B* DPhase
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! _: L( j7 C% k& U0 s& X1 \Ischemic Stroke Biological: Allogeneic adult mesenchymal bone marrow stem cells Phase I
, e% L \! p$ [+ \Phase II
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1 w0 R/ F8 g$ M, V9 }8 l7 ?( eStudy Type: # E. z- \! ]0 |7 E' {, l# l6 o
Interventional / D9 P! J! W3 N3 B9 a% S
Study Design: Allocation:Non-Randomized( }6 n5 W- A( c5 L$ \, F: g
Control:Uncontrolled
8 H" L& Q2 t' y4 @Endpoint Classification:Safety/Efficacy Study) O1 f: Q- Q$ b, }2 u& N! P, u6 @
Intervention Model:Single Group Assignment" _- V8 ]7 }4 i+ ?6 {+ C# I
Masking:Open Label* l! |$ | W$ @7 C8 l3 q
Primary Purpose:Treatment* _* ]. J/ O' y1 W1 O1 C. c
Official 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" \/ X+ z/ \9 m
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Further study details as provided by Stemedica Cell Technologies, Inc.:3 C- J9 t$ b! Q; `7 A4 N* v
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Primary Outcome Measures: 2 d, E, U: F, h/ [2 a
• 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]
3 G L4 u4 S! T4 bThe 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.! x7 @! s! }5 K* N2 C \
Secondary Outcome Measures:
- q" L" x9 M" S8 G* H• National Institutes of Health Stroke Scale Score. [Time Frame:12 months] [Designated as safety issue:Yes]
. y# W7 Z; q' y6 x- XThe 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:
; X! S+ G6 [7 H2 s3 c) g• Mini Mental Status Exam score. [Time Frame:12 month] [Designated as safety issue:Yes] 4 x% y; V# b; v. g8 j; k
The change from the baseline in Mini Mental Status Exam score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available.
' y4 d' K* V0 E+ r$ Z• Barthel Index Score. [Time Frame:12 month] [Designated as safety issue:Yes] " q. P. V0 j. x" a8 y
The change from the baseline in Barthel Index score at 1, 3, 6, 9, 12 months post-treatment, as available., E6 M8 Q5 x. w* @. J5 p; k: H3 |* C
• The Geriatric Depression Scale Score. [Time Frame:12 month] [Designated as safety issue:Yes] 8 Z* U! R, @, m: z7 d+ \
The change from baseline in the Geriatric Depression Scale score at 1, 3, 6, 9, 12 months post-treatment, as available.& l, R$ R1 U) K: C' f& s D9 n2 P
8 J+ Z" A8 b% w# J% V+ vEstimated Enrollment: 357 l( O+ y3 l) \4 U6 R
Study Start Date: February 2011
/ ^ B( M6 T# H7 hEstimated Study Completion Date: February 2013
& b3 {' ]8 E) |9 `/ ?Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)1 w4 F: {7 B, x- |( y- H% ?
Arms
" J6 }% X, \+ z. SAssigned Interventions J0 k5 u; ~* V6 Z
: `4 ?+ M, H+ G' aStem cells: Experimental : y/ ], N- |& i& @, f
All subjects will receive allogeneic adult mesenchymal bone marrow stem cells
, b( K* Q! T( E$ h4 O+ Q [6 q1 BIntervention: Biological: Allogeneic adult mesenchymal bone marrow stem cells Biological: Allogeneic adult mesenchymal bone marrow stem cells ; C1 S7 e6 ^' L L( T) W9 A- D
Patients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells c( i' {/ ?3 t+ @. t
3 p4 ~* W0 _- _, S1 w3 f0 n0 eDetailed Description:
/ {9 X' N8 }3 J- I3 dStroke 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. K p: G. V' }' ^# j) t& q/ X
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.
) M1 y! h; C4 y Eligibility
3 Z4 b' r! q: O) E7 w4 q, @, sAges Eligible for Study: 18 Years and older
2 r0 W( Z3 U3 l, m& q) wGenders Eligible for Study: Both
2 q# z$ @( ~& tAccepts Healthy Volunteers: No" }0 p, W9 F5 y+ G
Criteria' a% ?3 A2 c" a9 T' x
Inclusion Criteria:
# g* g8 R3 v* I5 Y @% @• Clinical diagnosis of ischemic stroke for longer than 6 months
' f, W* U Z. M• Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
# {7 J) [$ Q6 x0 X& F• No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment _; b; d& b! [0 {5 f$ ^
• NIHSS score between 6-20
+ A) h+ [# ~2 N• Life expectancy greater than 12 months
8 N* j( @. N/ k, d• Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke
- a; L7 B" ]7 b6 s7 m) j• Adequate organ function as defined by the following criteria: ! @7 y: F- q' P$ q
Exclusion Criteria:
8 t/ n0 g' p$ }7 K; f• History of uncontrolled seizure disorder
, [' Y3 E: O7 k• History of cancer within the past 5 years.
# F% h$ m& Y+ x. `# A• History of cerebral neoplasm
% @ X/ Y8 R' D& W; x• Positive for hepatitis B, C or HIV , {8 T8 @( @6 O9 Y
• Myocardial infarction withing six months of study entry ( P% {$ o9 S( a; F" [% j3 R
• Findings on baseline CT suggestive of subarachnoid or intracerebral hemorrhage within past 12 months.
; E1 \2 ^9 n/ |• Allergies to Bovine or Porcine products . j6 |5 A$ }/ _' z) q
Contacts and Locations# f8 F* |1 J; _% t; w: g" T* P
Please refer to this study by its ClinicalTrials.gov identifier: NCT012974136 x8 ]( }) P, K4 S' Q0 r
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Contacts3 D0 {- Y1 A- A
Contact: Michael L Levy, MD, PhD FACS 858-966-8574 % W2 W2 V9 N0 I0 S6 n
1 j# z! h V. ULocations3 i8 o$ J( ^% u- o
United States, California! w- A9 s( Y8 \3 P0 l' M
University of California San Diego Division of Neurological Surgery Recruiting
3 {. h2 X" z5 D8 j( C3 @) l4 ^San Diego, California, United States, 92123 + c3 y M& w0 L3 m0 C
Contact: Michael L Levy, MD, PhD FACS 858-966-8574 & k# P, d0 O. j% v/ s$ R
Principal Investigator: Michael L Levy, MD, PhD FACS
3 \0 V8 b3 j7 Y8 A" tSponsors and Collaborators o& Q) W1 k' c& H( C1 F; X
Stemedica Cell Technologies, Inc.
/ M- t3 y* Q0 g2 |; z' E8 M% cUniversity of California, San Diego
: b; Q9 Y- s }) @1 uInvestigators
. N& Q5 C1 E/ F* k3 g& xStudy Director: Lev Verkh, PhD Stemedica Cell Technologies, Inc.8 `6 m1 j" Z. p/ F, _0 s- O
More Information & x1 p( v' ?. E8 e# G
, G: y& |) y" c2 s0 FNo publications provided / A2 E, T/ Q3 t9 o
Responsible Party: Stemedica Cell Technologies, Inc. ( Lev Verkh, PhD Chief Regulatory & Clinical Development Officer )7 a& w" e% C' B/ R/ _
ClinicalTrials.gov Identifier: NCT01297413 History of Changes
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Other Study ID Numbers: STEM 101-M
6 e( ]8 V" ~+ T% JStudy First Received: February 10, 2011$ Y. A$ M/ G% I$ `7 z
Last Updated: February 15, 2011& K; |1 b! Y* q( O1 j. `; e% ` ^
Health Authority: United States: Food and Drug Administration
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! h! C, c) {, b9 L$ ~Keywords provided by Stemedica Cell Technologies, Inc.:
7 Y( _( S; v$ {8 B8 o( zAllogeneic adult stem cells ischemic stroke
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Additional relevant MeSH terms:
$ P5 o5 \: b X5 X+ E; E+ tIschemia' K+ w6 S& z% x1 F* L/ A
Stroke, m& [8 g7 d! {( k) U+ {( r/ |
Cerebral Infarction( ~$ x( w3 ]$ J5 t: k& @* }
Pathologic Processes% L; i3 k. p2 T; B
Cerebrovascular Disorders
% X+ g% a" Y( oBrain Diseases Central Nervous System Diseases
8 U* M3 p! F" D$ _) _/ d) ]& KNervous System Diseases& M; Q$ S1 F& o3 K1 M
Vascular Diseases$ v- d2 G$ S( u
Cardiovascular Diseases) Z! r v" j' j% y, i; U, W
Brain Infarction1 N! |6 x4 k6 I( s. A6 f: q
Brain Ischemia
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ClinicalTrials.gov processed this record on February 28, 2011
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