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Bone marrow mononuclear cells

Phase 2

Chronic Myocardial Ischemia | Unknown | Cardiovascular |Design Therapeutics, Inc.|Last Updated: Jun 30, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01454323Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.PHASE2 COMPLETED 20 — — Dec 1, 2010Feb 1, 2015Jun 30, 20151 Spain
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Study Endpoints
Primary Endpoints
Change from baseline in left ventricular ejection fraction (LVEF)
3, 6 and 12 months after intervention
Secondary Endpoints
Major Adverse Cardiac Events (MACE)
12 months
Functional grade of the New York Heart Association (NYHA)
3,6 and 12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
InterventionEXPERIMENTALDose of bone marrow mononuclear cells: 5-7 x 108 total cells
Interventions
NameTypeDescription
Bone marrow mononuclear cellsOTHERIntracoronary infusion of autologous bone marrow-derived mononuclear cells
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Aged between 18 and 80 years. 2. Patients diagnosed with Chronic anterior myocardial infarction (more than 6 months from the acute episode) with symptoms and / or signs of heart failure. 3. Left ventricular ejection fraction (LVEF)\<45% and distensibility changes. 4. Complete...

Countries:Spain
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