Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-01 @ 11:19 PM
Study NCT ID:
NCT04064866
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PRP for Treatment of Disc Pain
Sponsor:
Neurological Associates of West Los Angeles
Organization:
Study Overview
Official Title:
A Multi-Center, Randomized, Controlled, Double-blind Study Evaluating Safety and Efficacy of Hemocyte Autograft for Treatment of Single-Level and Multi- Level Lumbar, Thoracic and Cervical Discogenic Pain
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
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:
This is a multi-center, randomized, controlled, double-blind clinical trial comparing hemocyte autograft (platelet rich plasma) to control injection (placebo) in subjects with reported cervical, thoracic or lumbar pain for at least 3 months with Pfirrmann grade changes at 7 or less and who are being considered for discography in order to identify pain generator discs in evaluation of potential surgical candidates.
Detailed Description:
The study will recruit 180 subjects: 60 suffering from lumbar discogenic pain, 60 suffering from thoracic discogenic pain and 60 suffering from cervical discogenic pain. In each arm 40 study subjects will be randomized to receive hemocyte autograft, while 20 will be randomized to receive contrast as the control group. All subjects will have blood drawn (50 cc) from any access site and have it prepared for hemocyte autograft. Using a 20 gauge introducer and 25 gauge disc needle, subjects randomized to active condition will have exactly 3 cc of hemocyte autograft placed in a 3 cc syringe while subjects randomized to placebo will have exactly 3 cc of saline placed in a 3 cc syringe. The syringe barrels and tubing will be completely covered with opaque tape so that the injector is blinded to the contents. For both conditions, 1-2 cc of designated injectant (PRP for active, saline for placebo) will be injected into the nucleus pulposus of each identified treatment level disc for lumbar; 0.5-1 cc for thoracic and 0.5-1 cc for cervical. Primary endpoint will be at 8 weeks after injection. After 8 weeks subjects who received placebo are eligible for crossover to treatment arm with hemocyte autograft, and subject who received treatment arm are eligible for surgery if not improved.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: