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MSB-CAR001 Combined With Hyaluronan

Phase 1

Anterior Cruciate Ligament Injury | Monoclonal antibody | Musculoskeletal |Mesoblast Limited|Last Updated: Aug 15, 2018

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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01088191Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament ReconstructionPHASE1 COMPLETED 17 — — Mar 1, 2009Oct 1, 2014Aug 15, 20181 Australia
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Study Endpoints
Primary Endpoints
To determine the overall safety of MSB-CAR001 plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
2 years
Secondary Endpoints
To evaluate the overall efficacy with MSB-CAR001 plus Hyaluronan compared to Hyaluronan alone using MRI scans and x-ray of the involved knee joint and access the change in outcomes (KOOS, SF-36) and pain (VAS)
2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Hyaluronan AloneACTIVE_COMPARATORHyaluronan Alone
MSB-CAR001EXPERIMENTALSingle Dose of MSB-CAR001 Combined With Hyaluronan
Interventions
NameTypeDescription
MSB-CAR001 Combined With HyaluronanBIOLOGICALKnee Injection of Biological: MSB-CAR001 Combined With Hyaluronan Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan
HyaluronanDRUGHyaluronan alone
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Males or females at least 18 years of age, but not older than 40 2. ACL injury requiring reconstruction 3. Have undergone unilateral ACL reconstruction surgery within six months of injury; 4. Willing and able to undertake a standardized rehabilitation protocol 5. ACL graft us...

Countries:Australia
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