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A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke
M0 H5 m4 ~/ T* wThis study is currently recruiting participants.
: ~( P c: @* t2 x3 YVerified by Stemedica Cell Technologies, Inc., February 2011/ @5 o8 l0 q l, q
First Received: February 10, 2011 Last Updated: February 15, 2011 History of Changes
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9 e3 l$ c3 m7 YSponsor: Stemedica Cell Technologies, Inc.
1 s, g* |0 z% i7 H w4 ACollaborator: University of California, San Diego
8 g7 i& a; p: }0 C$ Z( X7 bInformation provided by: Stemedica Cell Technologies, Inc.3 K+ r, a, n- b
ClinicalTrials.gov Identifier: NCT012974138 a' |- {: J( R, T5 b8 ~
Purpose
; G7 H/ z2 V5 U4 i. yThe 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.
3 T" }- Q' X4 K2 UCondition
6 n# y3 Q+ V( C3 V. YIntervention 8 L1 y b% B$ @5 L1 ]% u
Phase o2 b+ A0 h# ~3 q
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Ischemic Stroke Biological: Allogeneic adult mesenchymal bone marrow stem cells Phase I
8 X0 h x# l9 gPhase II
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# z( N, x% Z) F# XStudy Type: . k! J4 {& J* V& N( P' W
Interventional
; v" }3 ~6 P$ d) T5 F& X! hStudy Design: Allocation:Non-Randomized/ t" \7 t2 Q* `8 d+ u4 C
Control:Uncontrolled
; e" S/ s( A6 _Endpoint Classification:Safety/Efficacy Study, Y- M$ d# M" w w; \! t2 a
Intervention Model:Single Group Assignment
( p/ V7 \0 P# I BMasking:Open Label, g% f+ H: @' D3 W( w9 C- z$ W9 b% d
Primary Purpose:Treatment% z2 s" G( `# m
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
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6 w* b& O" C6 R0 sFurther study details as provided by Stemedica Cell Technologies, Inc.:
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Primary Outcome Measures:
9 N5 A. g4 l; h8 {7 w• 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]
) H5 d" }2 w( S/ L# D# k8 }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.
& ^, \8 W& X3 T5 ASecondary Outcome Measures:
' H, e! K# s6 U9 e) f• National Institutes of Health Stroke Scale Score. [Time Frame:12 months] [Designated as safety issue:Yes]
/ w" o+ `% @ F7 C- t7 Y$ ^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:( n( I8 r7 A1 [$ U, j( o @
• Mini Mental Status Exam score. [Time Frame:12 month] [Designated as safety issue:Yes] $ a; G# I! u! `1 a/ H
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.$ u) j( [3 r$ O. S/ j/ U( F6 P9 P
• Barthel Index Score. [Time Frame:12 month] [Designated as safety issue:Yes] ?* }) i, c. s6 C6 H- {
The change from the baseline in Barthel Index score at 1, 3, 6, 9, 12 months post-treatment, as available.
5 }; U; K7 |4 Z. E! ^• The Geriatric Depression Scale Score. [Time Frame:12 month] [Designated as safety issue:Yes] % I7 v* J" k# D( p: ~
The change from baseline in the Geriatric Depression Scale score at 1, 3, 6, 9, 12 months post-treatment, as available.# J4 H2 a% F+ O
$ ]; c2 u) m. V$ M+ ~2 \Estimated Enrollment: 35- j" a; A& x- h+ F% h( n2 }. V( b
Study Start Date: February 2011
9 Z* Q* \0 l2 @Estimated Study Completion Date: February 2013
. ?9 _' Z2 }: WEstimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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Assigned Interventions . j& N, {6 {# k& t- B0 T' ?
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Stem cells: Experimental
; M! w' R7 G& t7 b% z/ ~All subjects will receive allogeneic adult mesenchymal bone marrow stem cells
6 K7 k; ~! |0 g) ^Intervention: Biological: Allogeneic adult mesenchymal bone marrow stem cells Biological: Allogeneic adult mesenchymal bone marrow stem cells
! r$ T+ H* W- I9 }8 Y8 lPatients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells0 e( b9 f/ x9 ~" g
1 _' X2 Z( @+ @; v, _Detailed Description:
9 n. P9 u/ @( g n+ z9 }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.- q: z0 M5 G+ ^2 p0 G. g
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.1 J, d( j0 F. M' B
Eligibility
8 B- B% u' k1 R0 [7 aAges Eligible for Study: 18 Years and older
" U. I+ D- |% IGenders Eligible for Study: Both* p) b+ n2 I6 ^0 l
Accepts Healthy Volunteers: No! y" D! h: B1 a6 o
Criteria9 b8 E* e2 G$ P& e3 {; E3 K
Inclusion Criteria:
3 Z' F' W3 V5 F6 ]+ |, ?. c% j• Clinical diagnosis of ischemic stroke for longer than 6 months
) `7 M( \) q& d D- b2 B; d• Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
1 L& m& l- y- Z9 X f• No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
^+ e1 e' u3 G3 m# [• NIHSS score between 6-20 ( {) A! k8 Y. H9 N4 |- G7 l" q: Q6 ?2 a
• Life expectancy greater than 12 months ) r5 }/ @5 a, n# z% b' l9 n& q
• Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke 2 x4 n% Q' S* m6 T3 U9 _, W
• Adequate organ function as defined by the following criteria:
$ @0 X. d; I1 h! kExclusion Criteria:1 l/ f- H8 |- b" S- K
• History of uncontrolled seizure disorder * D& Z1 {0 q+ q
• History of cancer within the past 5 years. ) O% D* U. A& {# o/ |8 D$ }3 T
• History of cerebral neoplasm " o& j( w* b5 O! J6 j" o9 i- v5 Z
• Positive for hepatitis B, C or HIV ) S# ]2 d: ?% T# [$ J, J7 T
• Myocardial infarction withing six months of study entry
( C& X; B. P y# c2 H7 H) J• Findings on baseline CT suggestive of subarachnoid or intracerebral hemorrhage within past 12 months. 0 H" R. h& v0 n5 k, e
• Allergies to Bovine or Porcine products : p+ {0 T6 @$ I( q
Contacts and Locations' j6 J; X- E4 a' u
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297413+ }! w% B$ ~ T8 V7 ]; M
, ^+ @, ^# k4 X" y1 T, WContacts% W$ p1 b) H/ r: I$ x
Contact: Michael L Levy, MD, PhD FACS 858-966-8574
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0 x$ B g- ?8 g K; VLocations0 i5 q& P( V5 T# B# D
United States, California
- Z& a! W$ ^5 uUniversity of California San Diego Division of Neurological Surgery Recruiting
# w% o2 I* a3 ^. {; O& `8 O7 I8 cSan Diego, California, United States, 92123
0 |' t! P' B! _2 _Contact: Michael L Levy, MD, PhD FACS 858-966-8574 2 _8 b$ ~" V# h, {6 v7 w S4 D
Principal Investigator: Michael L Levy, MD, PhD FACS 1 T9 }" P- q S2 O2 m& F( L8 c
Sponsors and Collaborators
9 h1 @; s5 q& ^( ]7 `; m6 P$ RStemedica Cell Technologies, Inc.) z& S0 c" [* v! C8 w! a+ ?/ S4 o
University of California, San Diego
6 q; ?1 L# b: f$ UInvestigators: T1 c7 \+ ^' m6 Z* `
Study Director: Lev Verkh, PhD Stemedica Cell Technologies, Inc.
" ^7 ?+ w' r$ R5 D( b3 z. E& N More Information
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No publications provided + c9 p$ V1 \2 b+ W+ h
Responsible Party: Stemedica Cell Technologies, Inc. ( Lev Verkh, PhD Chief Regulatory & Clinical Development Officer )
0 i1 h' j1 J: e. p7 b* O) qClinicalTrials.gov Identifier: NCT01297413 History of Changes ! u: n. C' O) b) t4 N7 z+ k4 s
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Other Study ID Numbers: STEM 101-M1 ^1 F* Y- A6 Z K
Study First Received: February 10, 20115 H1 l l. @# ~0 c# C( X
Last Updated: February 15, 2011
3 A# J( e3 S+ c. X6 t/ x. t2 ^; eHealth Authority: United States: Food and Drug Administration
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Keywords provided by Stemedica Cell Technologies, Inc.: * n/ B# }9 g! M" x
Allogeneic adult stem cells ischemic stroke " k6 N, f2 ]. X& {7 `
( B# H+ }0 ]' n+ ~0 w x" xAdditional relevant MeSH terms:
5 y% R4 k t' t( \$ o3 f+ @Ischemia
8 |% u; r0 b, }. qStroke. t6 T3 f( z" D. C& o
Cerebral Infarction6 m( }! q9 \6 @) C" W9 F9 \3 Z
Pathologic Processes
5 ~+ M% S7 B. kCerebrovascular Disorders
" W1 a) n G/ b9 B0 ABrain Diseases Central Nervous System Diseases
( S# F b. V# ^3 h5 JNervous System Diseases
5 }2 _: i- Y" Q2 V3 ~Vascular Diseases: R9 W4 F; e) s. J
Cardiovascular Diseases
8 K ^4 `/ J- w# E- Q9 fBrain Infarction. j+ b+ B1 l" z- g4 w' f
Brain Ischemia' c+ c) J. o, h( j5 h
3 A- ?5 W9 v" B0 nClinicalTrials.gov processed this record on February 28, 2011
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发表于 2011-3-4 16:30
