NCT02379689

Efficacy of Intradiscal Injection of Viable Placental Tissue Extract in Subjects With One or Two Level, Symptomatic Lumbar Intervertebral Disc Degeneration

A Randomized, Double-Blinded, Placebo-Controlled With Crossover Study to Evaluate the Efficacy of Intradiscal Injection of Viable Placental Tissue Extract in Subjects With One or Two Level, Symptomatic Lumbar Intervertebral Disc Degeneration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Semmes-Murphey Foundation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Dr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic, P.C. ("Semmes-Murphey"). This study will look at a product that is derived from human tissue, that will be injected into the affected disc. With this study, the investigators hope to find a safe and effective way to treat degenerative disc disease.

Detailed description

Dr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic, P.C. ("Semmes-Murphey"). This study will look at a product that is derived from human tissue, that will be injected into the affected disc. With this study, we hope to find a safe and effective way to treat degenerative disc disease. This study will compare injectable placental tissue extract called BioDGenesis ("Active Product") to injectable Normal Saline ("Placebo"). The Active Product is supplied by BioD, LLC ("BioD"). You have a 50 percent chance of receiving the Placebo The study will last for 52 weeks. After all patients have been enrolled in the study and have completed 26 weeks, the Investigator will conduct a safety and efficacy analysis. If the investigator determines that the Active Product is more effective than Placebo in treating degenerative disc disease and there are no safety concerns with the Active Product, patients who received Placebo will have the option of receiving the Active Product through week 52.

Conditions

• Degenerative Disc Disease
• Pain

Interventions

Type	Name	Description
DRUG	Injectable placental tissue extract called BioDGenesis (Active Product)
DRUG	Placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• First posted: 2015-03-05
• Last updated: 2015-11-17

Locations

1 site across 1 country: United States