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autologous mesenchymal stem cells implantation

Phase 1

Tibial Fracture | Unknown | Musculoskeletal |Teva Pharmaceutical Industries Limited|Last Updated: Apr 28, 2011

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00250302Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial FracturesPHASE1 COMPLETED 24Apr 1, 2009Apr 1, 2011Apr 28, 20111 Israel
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Study Endpoints
Primary Endpoints
Safety
Number of patients reaching clinical union of fracture
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
autologous mesenchymal stem cells implantationPROCEDURE -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * ages 18 and 65. males not involved in active military duty. females- non child bearing potential. distal tibia third fracture without joint involvement. fracture treated by IM nail, percutaneous plating or external fixation. Exclusion Criteria: * active systemic or local inf...

Countries:Israel
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