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ALLO-ASC-DFU

Phase 1

Diabetic Foot Ulcer | Monoclonal antibody | Other |Co-Diagnostics, Inc.|Last Updated: Oct 16, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02394886Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot UlcersPHASE1 COMPLETED 5Nov 1, 2014Jul 1, 2015Oct 16, 20151 South Korea
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
up to 4 weeks
Secondary Endpoints
Wound size and depth measurement
baseline and 1, 2, 4 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALLO-ASC-DFUEXPERIMENTALALLO-ASC-DFU treatment with conventional care
Interventions
NameTypeDescription
ALLO-ASC-DFUBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subject is between 18 and 80 years of age. 2. Subject is diagnosed with Type I or Type II diabetes. 3. Subjects who have a wound defined as diabetic foot ulcer presence for more than 4 weeks, but not present for more than 54 weeks at the screening visit. 4. Foot ulcer located...

Countries:South Korea
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