27
Participants
Start Date
May 17, 2016
Primary Completion Date
December 31, 2018
Study Completion Date
February 18, 2019
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."
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.
ProPlaz PPC
Trademarked name of an FDA-cleared product
Georgia Pain and Spine, Peachtree City
Millenium Pain Center, Chicago
Precision Spine Care, Tyler
Comprehensive Spine and Sports Center, Campbell
Neurological Associates of West LA, Santa Monica
The Spine Institute: Center for Spinal Restoration, Santa Monica
Thrive Treatment, Santa Monica
Collaborators (2)
EmCyte Corporation
INDUSTRY
BioRich Medical
UNKNOWN
Neurological Associates of West Los Angeles
OTHER