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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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, Symptomati

Brief 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 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, 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.


Sponsor: Semmes-Murphey Foundation

Current Primary Outcome:

  • • To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract (IPE) on lower back pain (VAS). [ Time Frame: 52 weeks ]
  • • To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on disability (ODI). [ Time Frame: 52 weeks ]
  • • To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on quality of life (EQ-5D). [ Time Frame: 52 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome: • Composite outcome measure: Change from baseline and compared to Tissue Suspension Solution in qualitative assessments [ Time Frame: 52 weeks ]

• Composite outcome measure: Change from baseline and compared to Tissue Suspension Solution in qualitative assessments associated with MRI imaging (T2-weighted image), including Pfirrman score, modic changes, annular tears/fissures, endplate integrity, herniation and additional observations at 12 weeks of treatment.


Original Secondary Outcome: Same as current

Information By: Semmes-Murphey Foundation

Dates:
Date Received: February 24, 2015
Date Started: December 2014
Date Completion:
Last Updated: November 16, 2015
Last Verified: November 2015