Safety and Efficacy of PRP for Treatment of Disc Pain

NACompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

May 17, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

February 18, 2019

Conditions
Discogenic Pain
Interventions
DEVICE

High yield pure PRP

"The investigational product is hemocyte autograft derived from the subject's own blood. Subjects with a clinical diagnosis of discogenic pain had a discogram with ¼ cc to ½ cc of contrast injected by hand (leaving up to ½ cc contrast in the needle lumen and connecting tube); any concordant pain will be noted. Subjects received the injectant delineated by coordinator-provided randomization. Subjects were awake for the entirety of study treatment procedure.~All subjects had blood drawn (50 cc) from any access site and double-centrifuged using the EmCyte Hemocyte Autograft system; the first spin separated the buffy coat, the second spin and subsequent siphoning separated a purified platelet sample."

OTHER

Placebo

Placebo injections will have saline placed in centrifuges and run for the duration required for PRP preparation. 3cc of saline will be placed in 3 cc syringes with opaque tape around the barrel to cover the fluid chamber. 1-2 cc of saline will be injected into the nucleus pulposus of each treatment level disc under fluoroscopy for lumbar; 0.5-1 cc for thoracic and 0.5-1 cc for cervical.

DEVICE

ProPlaz PPC

Trademarked name of an FDA-cleared product

Trial Locations (7)

30269

Georgia Pain and Spine, Peachtree City

61704

Millenium Pain Center, Chicago

75701

Precision Spine Care, Tyler

89148

Comprehensive Spine and Sports Center, Campbell

90403

Neurological Associates of West LA, Santa Monica

The Spine Institute: Center for Spinal Restoration, Santa Monica

90405

Thrive Treatment, Santa Monica

Sponsors
All Listed Sponsors
collaborator

EmCyte Corporation

INDUSTRY

collaborator

BioRich Medical

UNKNOWN

lead

Neurological Associates of West Los Angeles

OTHER