Santa Monica, CA

Source Healthcare

Spinal Diseases

Spinal Stenosis

Intervertebral Disc Degeneration

Low Back Pain

Back Pain

SB-01

Spine BioPharma

Vertos Medical

Vivex Biomedical

condition

allSponsorName

MCRA

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.

Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

Source Healthcare | Santa Monica, CA

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Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine (MODEL)

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