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Chondrogen

Phase 1

Recovery Following Partial Medial Meniscectomy | Small molecule | Other |Mesoblast Limited|Last Updated: Jan 11, 2022

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00702741Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following MeniscectomyPHASE1 COMPLETED 55Jun 1, 2008Sep 1, 2011Jan 11, 20224 United States
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Study Endpoints
Primary Endpoints
Comparison of treatment adverse event rates
Through 3 years
Secondary Endpoints
Concomitant Medications
Through 3 years
Visual Analog Scale
Through 3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALChondrogen (low dose)
BEXPERIMENTALChondrogen (high dose)
CPLACEBO_COMPARATORHyaluronan
Interventions
NameTypeDescription
ChondrogenDRUGIntra-articular injection of ex vivo cultured adult human mesenchymal stem cells
PlaceboDRUGIntra-articular injection of Hyaluronan
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Subject must have received an injection in Protocol No. 550 * Subject must have completed the 6-month and final 2-year visit in Protocol No. 550 * Subject must provide written informed consent for entry into the extension study * Subject must provide authorization for use and ...

Countries:United States
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