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Lumbar Interbody Fusion with Autograft

Phase 2

Degenerative Disc Disease | Monoclonal antibody | Neurology |Mesoblast Limited|Last Updated: Jun 29, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Lumbar Interbody Fusion with Autograft · 1 trial · 3 indications

Phase 2 1
NCT00996073Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody FusionDegenerative Disc Disease
COMPLETED24 Analytics
PHASE2COMPLETED
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
Degenerative Disc Disease
NCT0099607324
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Study Endpoints

Primary Endpoints

To determine the overall safety of NeoFuse 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 overall fusion success with NeoFuse plus carrier compared to autograft using CT scans and x-ray of the involved lumbar spine levels and assess the change in outcomes (ODI, SF-36, and WPAI) and pain (VAS)at the 12-month follow-up visit.
3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AutograftACTIVE_COMPARATORLumbar Interbody Fusion with Autograft
Low DoseEXPERIMENTALLumbar Interbody Fusion with NeoFuse-Low Dose
High DoseEXPERIMENTALLumbar Interbody Fusion with NeoFuse-High Dose

Interventions

NameTypeDescription
Lumbar Interbody Fusion with AutograftBIOLOGICALSingle Dose Autograft Surgical Implantation
Lumbar Interbody Fusion with NeoFuseBIOLOGICALSingle Dose NeoFuse Surgical Implantation
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Male or females at least 18 years of age, but not older than 70. 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 fo...

Countries:United States
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Competitive Landscape -Degenerative Disc Disease 12 trials

CompanyTickerTrialsLead PhaseDrugs
Mesoblast Limited Sponsored ADRMESO1PHASE3Rexlemestrocel-L, HA mixture, Saline
Creative Medical Technology Holdings, Inc.CELZ1PHASE1CELZ-201-DDT
Stryker CorporationSYK2N/AUndisclosed
Globus Medical Inc Class AGMED6 - Undisclosed
Orthofix Medical, Inc.OFIX1 - Undisclosed
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Frequently asked questions about Lumbar Interbody Fusion with Autograft

What is Lumbar Interbody Fusion with Autograft used for?

Lumbar Interbody Fusion with Autograft is used for degenerative disc disease, a condition where spinal discs break down and cause pain. It is a surgical procedure that fuses vertebrae using the patient's own bone to stabilize the spine. The investigational therapy is being studied in patients requiring lumbar interbody fusion.

Who makes Lumbar Interbody Fusion with Autograft?

Lumbar Interbody Fusion with Autograft is developed by Mesoblast Limited, a biopharmaceutical company traded on the NASDAQ under the ticker MESO. The company is conducting clinical research on this therapy for degenerative disc disease.

What phase is Lumbar Interbody Fusion with Autograft in?

Lumbar Interbody Fusion with Autograft is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with degenerative disc disease.

What clinical trials is Lumbar Interbody Fusion with Autograft in?

Lumbar Interbody Fusion with Autograft has one completed Phase 2 trial, NCT00996073, titled 'Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion.' The trial enrolled 24 participants in the United States with conditions including degenerative disc disease, degenerative spondylolisthesis, and spinal stenosis.

Is Lumbar Interbody Fusion with Autograft the same as NeoFuse?

Yes, Lumbar Interbody Fusion with Autograft is the same as NeoFuse. The clinical trial NCT00996073 refers to NeoFuse as the investigational product being studied for lumbar interbody fusion in patients with degenerative disc disease and related spinal conditions.