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Mesenchymal progenitor cells

Phase 2

Knee Osteoarthritis | Monoclonal antibody | Musculoskeletal |China Pharma Holdings, Inc.|Last Updated: Aug 1, 2023

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 Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04208646Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells for the Treatment of Knee OsteoarthritisPHASE2 COMPLETED 106May 16, 2020Jul 31, 2023Aug 1, 20237 China
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Study Endpoints
Primary Endpoints
WOMAC Score
24 weeks

The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points;96 points mean a worse outcome,will be tested at 24 weeks after the first injection

Secondary Endpoints
MRI quantitative analysis of articular cartilage
24 weeks,48 weeks
WOMAC Score
4、8、12、36、48 weeks
VAS Score
4、8、12、24、36、48 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mesenchymal progenitor cells Dosage 1EXPERIMENTALMesenchymal progenitor cells low-dose group
Mesenchymal progenitor cells Dosage 2EXPERIMENTALMesenchymal progenitor cells high-dose group
No mesenchymal progenitor cellsPLACEBO_COMPARATORNo mesenchymal progenitor cells
Interventions
NameTypeDescription
Mesenchymal progenitor cellsBIOLOGICALAllogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use
No mesenchymal progenitor cellsBIOLOGICALNo mesenchymal progenitor cells for intra- articular use
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Eligibility Criteria
Age Range40 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Subjects who understand and voluntarily sign the consent form before this study; 2. According to the diagnostic criteria (American Rheumatology Association, clinical + radiology criteria), patients with knee osteoarthritis are definitely diagnosed; 3. Age: 40-75, males and fe...

Countries:China
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