Study Results
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Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2016-05-17
2019-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
For subjects who cross over, follow-up schedule will reset with visits at 8 weeks and 26 weeks post-crossover.
TREATMENT
QUADRUPLE
Study Groups
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PRP/Hemocyte Autograft Intervention Arm
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. The syringe barrels and tubing were covered with opaque tape so that the injector was blinded to the contents. 1-2 cc of PRP was 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.
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.
ProPlaz PPC
Trademarked name of an FDA-cleared product
Placebo Control Arm
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 placebo condition will have exactly 3 cc of saline placed in a 3 cc syringe. 1-2 cc of saline was 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.
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.
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinically suspected discogenic pain in the cervical, thoracic or lumbar spine.
3. Bring considered for discography in order to identify source of pain in the evaluation of potential surgical candidates.
4. History of neck pain or mid or low back pain for at least 3 months.
5. Failed to respond to conservative therapies that include physical therapy and analgesics.
6. Documented Pfirrmann grade changes of 7 or less at each treatment level as represented by an MRI no more than 12 months old (extravasation not excluded).
Exclusion Criteria
2. Any contraindication for discography or surgery
3. Significant signs or symptoms of root or cord compression at treatment levels.
4. Any diagnosis of a concurrent pain disorder or other concurrent cause of disability.
5. Daily opioid requirements of greater than180 mg oral morphine equivalent
(OME) per day.
6. Current active systemic infection, or history of disc infection.
7. Untreated disabling thought or mood disorder.
8. Inability to provide informed consent including subjects in a socially compromised condition such as prisoners.
18 Years
ALL
No
Sponsors
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EmCyte Corporation
INDUSTRY
BioRich Medical
UNKNOWN
Neurological Associates of West Los Angeles
OTHER
Responsible Party
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Principal Investigators
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Sheldon E Jordan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Neurological Associates of West Los Angeles
Locations
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Comprehensive Spine and Sports Center
Campbell, California, United States
Neurological Associates of West LA
Santa Monica, California, United States
The Spine Institute: Center for Spinal Restoration
Santa Monica, California, United States
Thrive Treatment
Santa Monica, California, United States
Georgia Pain and Spine
Peachtree City, Georgia, United States
Millenium Pain Center
Chicago, Illinois, United States
Precision Spine Care
Tyler, Texas, United States
Countries
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References
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Terry, A., Lutz, G., et al. Lumbar Intradiscal Platelet Rich Plasma Injections: A Prospective, Double-Blind, Randomized Controlled Trial. (2013), International Spine Intervention Society - 2013 21st Annual Scientific Meeting Research Abstracts. Pain Medicine, 14: 1269-1276. doi: 10.1111/pme.12219, 2013.
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Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med. 2009 Nov;37(11):2259-72. doi: 10.1177/0363546509349921.
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Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma the perfect enhancement factor? A current review. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):93-103.
Peng BG. Pathophysiology, diagnosis, and treatment of discogenic low back pain. World J Orthop. 2013 Apr 18;4(2):42-52. doi: 10.5312/wjo.v4.i2.42. Print 2013 Apr 18.
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Anitua E, Padilla S. Biologic therapies to enhance intervertebral disc repair. Regen Med. 2018 Jan;13(1):55-72. doi: 10.2217/rme-2017-0111. Epub 2018 Jan 22.
Davis VL, Abukabda AB, Radio NM, Witt-Enderby PA, Clafshenkel WP, Cairone JV, Rutkowski JL. Platelet-rich preparations to improve healing. Part I: workable options for every size practice. J Oral Implantol. 2014 Aug;40(4):500-10. doi: 10.1563/AAID-JOI-D-12-00104.
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Gelalis ID, Christoforou G, Charchanti A, Gkiatas I, Pakos E, Papadopoulos D, Ploumis A, Korompilias A. Autologous platelet-rich plasma (PRP) effect on intervertebral disc restoration: an experimental rabbit model. Eur J Orthop Surg Traumatol. 2019 Apr;29(3):545-551. doi: 10.1007/s00590-018-2337-1. Epub 2018 Oct 28.
Khalaf K, Nikkhoo M, Ya-Wen Kuo, Yu-Chun Hsu, Parnianpour M, Campbell-Kyureghyan N, Haghpanahi M, Jaw-Lin Wang. Recovering the mechanical properties of denatured intervertebral discs through Platelet-Rich Plasma therapy. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:933-6. doi: 10.1109/EMBC.2015.7318516.
Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
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Fujita N, Imai J, Suzuki T, Yamada M, Ninomiya K, Miyamoto K, Iwasaki R, Morioka H, Matsumoto M, Chiba K, Watanabe S, Suda T, Toyama Y, Miyamoto T. Vascular endothelial growth factor-A is a survival factor for nucleus pulposus cells in the intervertebral disc. Biochem Biophys Res Commun. 2008 Jul 25;372(2):367-72. doi: 10.1016/j.bbrc.2008.05.044. Epub 2008 May 19.
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Everts PA, Malanga GA, Paul RV, Rothenberg JB, Stephens N, Mautner KR. Assessing clinical implications and perspectives of the pathophysiological effects of erythrocytes and plasma free hemoglobin in autologous biologics for use in musculoskeletal regenerative medicine therapies. A review. Regen Ther. 2019 May 10;11:56-64. doi: 10.1016/j.reth.2019.03.009. eCollection 2019 Dec.
Hussain N, Johal H, Bhandari M. An evidence-based evaluation on the use of platelet rich plasma in orthopedics - a review of the literature. SICOT J. 2017;3:57. doi: 10.1051/sicotj/2017036. Epub 2017 Oct 9.
Sanapati J, Manchikanti L, Atluri S, Jordan S, Albers SL, Pappolla MA, Kaye AD, Candido KD, Pampati V, Hirsch JA. Do Regenerative Medicine Therapies Provide Long-Term Relief in Chronic Low Back Pain: A Systematic Review and Metaanalysis. Pain Physician. 2018 Nov;21(6):515-540.
van Hooff ML, Spruit M, Fairbank JC, van Limbeek J, Jacobs WC. The Oswestry Disability Index (version 2.1a): validation of a Dutch language version. Spine (Phila Pa 1976). 2015 Jan 15;40(2):E83-90. doi: 10.1097/BRS.0000000000000683.
Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10.
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Navani A, Manchikanti L, Albers SL, Latchaw RE, Sanapati J, Kaye AD, Atluri S, Jordan S, Gupta A, Cedeno D, Vallejo A, Fellows B, Knezevic NN, Pappolla M, Diwan S, Trescot AM, Soin A, Kaye AM, Aydin SM, Calodney AK, Candido KD, Bakshi S, Benyamin RM, Vallejo R, Watanabe A, Beall D, Stitik TP, Foye PM, Helander EM, Hirsch JA. Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician. 2019 Jan;22(1S):S1-S74.
Pettine KA, Suzuki RK, Sand TT, Murphy MB. Autologous bone marrow concentrate intradiscal injection for the treatment of degenerative disc disease with three-year follow-up. Int Orthop. 2017 Oct;41(10):2097-2103. doi: 10.1007/s00264-017-3560-9. Epub 2017 Jul 26.
Other Identifiers
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31135/1
Identifier Type: -
Identifier Source: org_study_id
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