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A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

2014-07-23 21:09:04 | BioPortfolio

Summary

Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Degenerative Disc Disease

Intervention

Intradiscal rhGDF-5, Water for injection

Location

The Spine Institute
Santa Monica
California
United States
90404

Status

Recruiting

Source

Advanced Technologies and Regenerative Medicine, LLC (ATRM)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:04-0400

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Medical and Biotech [MESH] Definitions

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.

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An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.

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