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ALLOB cells with ceramic scaffold

Phase 2

Degenerative Disc Disease | Small molecule | Other |Bone Biologics Corp|Last Updated: Jan 29, 2021

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
UNCONTROLLED
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02205138Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal FusionPHASE2 COMPLETED 38Oct 1, 2014Jan 25, 2021Jan 29, 20218 Belgium
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Study Endpoints
Primary Endpoints
Lumbar fusion progression as assessed by CT scan
12 months
Functional Disability using Oswestry Disability Index
12 months
Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements
12 months
Secondary Endpoints
Pain using a Visual Analogue Scale
12 months
Global Disease Evaluation using a Visual Analogue Scale
12 months
Functional Disability using Oswestry Disability Index
12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALLOB® cells with ceramic scaffoldEXPERIMENTALALLOB® cells with ceramic scaffold Implantation
Interventions
NameTypeDescription
ALLOB® cells with ceramic scaffoldDRUGEach patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements * Symptomatic degenerative disc disease of the lumbar spine requiring a single level lumbar fusion (L1-S1) * Unresponsive...

Countries:Belgium
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