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Mesenchymal stem cells

Phase 1

Chronic Myocardial Ischemia | Gene therapy | Cardiovascular |Establishment Labs Holdings Inc.|Last Updated: Sep 19, 2014

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 Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01076920Mesenchymal Stem Cells and Myocardial IschemiaPHASE1 COMPLETED 10Oct 1, 2009Sep 1, 2014Sep 19, 20141 France
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Study Endpoints
Primary Endpoints
Evaluate safety and feasibility of transendocardial injection using the NogaStar XP Mapping Catheter with the MyostarTM Left Ventricular Injection Catheter of autologous MSC in subjects with chronic myocardial ischemia and left ventricular dysfunction
30 days
Secondary Endpoints
Change from baseline in SF-36, VO2max, 6 min walk test, and the NYHA, CCS Classifications Effect related to cardiac function
30 days to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intervention armEXPERIMENTAL -
Interventions
NameTypeDescription
Mesenchymal stem cellsGENETIC60x106 MSCs Trans-endocardial intramyocardial injections (n=14-16)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age 18 to 75 2. Male or female 3. NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with) 4. Chronic coronary artery disease with left ventricular function below 35% 5. Stable medical therapy for at least one month 6. Reversible pe...

Countries:France
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