Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02379689
Status:
UNKNOWN
Last Update Posted:
2015-11-17
First Post:
2015-02-24
Brief Title:
Efficacy of Intradiscal Injection of Viable Placental Tissue Extract in Subjects With One or Two Level Symptomatic Lumbar Intervertebral Disc Degeneration
Sponsor:
Semmes-Murphey Foundation
Organization:
Semmes-Murphey Foundation
Study Overview
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 Symptomatic Lumbar Intervertebral Disc Degeneration
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PC 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 PC 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None