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ALLOB cells with ceramic scaffold

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

ALLOB cells with ceramic scaffold · 1 trial · 1 indication

Phase 2 1
NCT02205138Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal FusionDegenerative Disc Disease
COMPLETED38 Analytics
PHASE2COMPLETED
Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion
Degenerative Disc DiseaseUnlock trial analytics

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 to 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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Competitive Landscape -Degenerative Disc Disease 12 trials

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Frequently asked questions about ALLOB cells with ceramic scaffold

What is ALLOB cells with ceramic scaffold?

ALLOB cells with ceramic scaffold is an investigational biologic product being developed by Bone Biologics Corp (BBLG) for degenerative disc disease. It combines allogeneic osteoblastic cells with a ceramic scaffold and is intended for use in lumbar spinal fusion procedures. The product is in Phase 2 clinical development.

What is ALLOB cells with ceramic scaffold used for?

ALLOB cells with ceramic scaffold is being studied for degenerative disc disease, specifically in lumbar spinal fusion. The Phase 2a trial evaluated its use in that indication. It is not approved for any indication and remains investigational.

Who makes ALLOB cells with ceramic scaffold?

ALLOB cells with ceramic scaffold is developed by Bone Biologics Corp, which trades under the ticker BBLG. The company is the sponsor of the clinical program for this product.

What phase is ALLOB cells with ceramic scaffold in?

ALLOB cells with ceramic scaffold is in Phase 2 development. One Phase 2a trial has been completed, and no active trials are currently listed. The product is investigational and has not been approved by the FDA.

What clinical trials is ALLOB cells with ceramic scaffold in?

ALLOB cells with ceramic scaffold has been studied in one completed Phase 2a trial, NCT02205138, titled Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion. The trial enrolled 38 participants with degenerative disc disease in Belgium and was uncontrolled.