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MultiStem

Phase 3

Ischemic Stroke | Monoclonal antibody | Neurology |Medpace Holdings, Inc. Common Stock|Last Updated: Aug 2, 2016

Development status

Highest phase Phase 3 (NCT03545607)
Phase scored for MEDPPhase 2
Registered trials 2 across 1 sponsor since Sep 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment134

FDA Designations

No designations recorded

Clinical trial landscape

MultiStem · 1 trial · 1 indication

Phase 2 1
NCT01436487Study to Examine the Effects of MultiStem in Ischemic StrokeIschemic Stroke
COMPLETED134 Analytics
PHASE2COMPLETED
Study to Examine the Effects of MultiStem in Ischemic Stroke
Ischemic Stroke
NCT01436487134
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Study Endpoints

Primary Endpoints

frequency of dose limiting adverse events
7 days
Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)
90 days

Secondary Endpoints

proportion of subjects with a mRS score of less than or equal to 2
90 days
change in functional outcome throughout range of mRS scores
90 days
changes in outcome measures (mRS, NIHSS, BI) over time
365 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALLow dose MultiStem or Placebo
Cohort 2EXPERIMENTALHigh dose MultiStem or Placebo
Cohort 3EXPERIMENTALHighest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo

Interventions

NameTypeDescription
MultiStemBIOLOGICALsingle infusion 1-2 days following ischemic stroke
PlaceboBIOLOGICALsingle infusion 1-2 days following ischemic stroke
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Eligibility Criteria

Age Range18 Years to 83 Years
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Male or female subjects between 18 and 83 years of age (inclusive) * Clinical diagnosis of cortical cerebral ischemic stroke * Occurrence of a moderate to moderately severe stroke Exclusion Criteria: * Presence of a lacunar or a brainstem infarct * Reduced level of conscious...

Countries:United StatesUnited Kingdom
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