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Single Dose MPCs

Phase 2

Degenerative Disc Disease | Monoclonal antibody | Other |Mesoblast Limited|Last Updated: Jun 26, 2020

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01290367Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back PainPHASE2 COMPLETED 100Aug 1, 2011Jul 1, 2015Jun 26, 202014 United States, Australia
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Study Endpoints
Primary Endpoints
To determine the overall safety of MPCs 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).
3 years
Secondary Endpoints
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MPCs.
6 - 36 Months
To evaluate the effectiveness of MPCs in reducing chronic lumbar back pain using the visual analog scale (VAS).
1 - 36 Months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
High Dose MPCsEXPERIMENTALInjection of High Dose MPCs with Hyaluronic Acid
Low Dose MPCsEXPERIMENTALInjection of Low Dose MPCs with Hyaluronic Acid
Saline injectionSHAM_COMPARATORInjection of saline solution.
Hyaluronic acid injectionPLACEBO_COMPARATORInjection of hyaluronic acid solution
Interventions
NameTypeDescription
Single Dose MPCs InjectionBIOLOGICALInjection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Single injection of saline solutionPROCEDUREIntradiscal control injection with saline solution
Single injection of hyaluronic acidPROCEDUREIntradiscal control injection with hyaluronic acid
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. Male or females at least 18 years of age. 2. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. 3. Have the ability to understand and provide written authorization for the use and disclosur...

Countries:United StatesAustralia
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