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Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Degenerative Disc Disease
Intradiscal rhGDF-5, Water for injection
The Spine Institute
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Published on BioPortfolio: 2014-07-23T21:09:04-0400
Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.
SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension will be administered via a single intradiscal injection to subjects with degenerative disc dis...
The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal inject...
This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls. This trial will evaluate ...
Present the long-term clinical and radiographic comparison between the Prestige-LP cervical disc replacement and the Zero-p spacer cervical disc fusion in treatment of patients with symptomatic two-le...
The aim of the study was to identify inflammatory cytokines/chemokines associated with neuroinflammation and periphery-to-CNS inflammatory cross-talk in degenerative disc disease (DDD) and lumbar disc...
Degenerative disc disease (DDD) is associated with longitudinal remodeling of paravertebral tissues. While chronic vertebral changes in advanced stages of DDD are well-studied, very little data exists...
Lumbar interbody fusion (LIF) is a treatment option for patients with degenerative disc disease (DDD). However, the effects of the most common LIF procedures-posterior LIF, transforaminal LIF, and ant...
Nucleus pulposus (NP) cell senescence is an important cellular feature within the degenerative disc. It is known that a very acidic niche exists in the degenerative disc, which participates in regulat...
The dissolving of the NUCLEUS PULPOSUS, the semi-gelatinous tissue of a displaced INTERVERTEBRAL DISC. It is usually achieved by the direct injection of a proteolytic enzyme, especially CHYMOPAPAIN, into the herniated disc.
Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates.
Fibrocartilage inner core of the intervertebral disc. Prolapsed or bulged nucleus pulposus leads to INTERVERTEBRAL DISC DISPLACEMENT while proliferation of cells in the nucleus pulposus is associated with INTERVERTEBRAL DISC DEGENERATION.
An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.
The replacement of intervertebral discs in the spinal column with artificial devices. The procedure is done in the lumbar or cervical spine to relieve severe pain resulting from INTERVERTEBRAL DISC DEGENERATION.