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Safety and Efficacy of PRP for Treatment of Disc Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064866
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborators:
EmCyte Corporation
BioRich Medical
Information provided by (Responsible Party):
Neurological Associates of West Los Angeles

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.

Condition or disease Intervention/treatment Phase
Discogenic Pain Device: High yield pure PRP Other: Placebo Device: ProPlaz PPC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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. Randomization ratio was 2:1. 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.

For subjects who cross over, follow-up schedule will reset with visits at 8 weeks and 26 weeks post-crossover.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigator, care provider, and participant were all blinded to injection contents (e.g., hemocyte autograft intervention vs. placebo control) An independent blinded evaluator assessed subjects at 4 weeks and 8 weeks. An unblinded or blinded evaluator will assess subjects at 26 weeks.
Primary Purpose: Treatment
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
Actual Study Start Date : May 17, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : February 18, 2019

Arm Intervention/treatment
Experimental: 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.
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 Name: PRP

Device: ProPlaz PPC
Trademarked name of an FDA-cleared product
Other Name: BioRich Medical ProPlaz Protein Plasma Concentrator

Placebo Comparator: 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.
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.
Other Name: Control




Primary Outcome Measures :
  1. Patient Specific Functional Scale (PSFS) [ Time Frame: 8 weeks from baseline ]

    The primary objective of this study is to determine safety and efficacy of a single injection of hemocyte autograft into diseased discs for the treatment of back and neck pain. The PSFS is a self-report, patient-specific outcome measure designed to assess functional change in patients with pain and musculoskeletal disorders. The total score = the sum of the activity scores (10 maximum, which reflects a better level of functioning)/the number of activities (7 maximum). At least two points improvement on the average Pain Specific Functional

    Scale (PSFS).


  2. Adverse Event Reporting [ Time Frame: Baseline to 26 weeks ]
    Adverse events (AEs) and any other untoward signs or symptoms were collected at each study timepoint starting at the treatment injection. Serious adverse events (SAEs) determined by the investigator to be related to the study treatment were formally recorded. [NOTE: NONE REPORTED THROUGHOUT STUDY DURATION]


Secondary Outcome Measures :
  1. Numeric Pain Rating Scale (NRPS) [ Time Frame: 8 weeks from baseline ]
    The NRPS is a unidimensional measure of pain intensity for adults. The 11-point numeric scale ranges from '0' representing 'no pain' to 10 representing 'worst possible pain.' The NPRS can be administered verbally or graphically for self-completion. The respondent is asked to indicate the numeric scale value that best describes the intensity of their pain within the last 24-hours. Clinical improvement was denoted by at least 3 points improvement in Numeric Pain Rating Scale (NPRS)

  2. Oswestry Disability Index (ODI) [ Time Frame: 8 weeks from baseline ]
    A measure to gauge improvement in pain symptoms among lumbar and thoracic spine conditions. The ODI is a patient-based questionnaire which gives a subjective percentage score of functionality/disability for a list of activities of daily living among those rehabilitating from lower back pain. There are 6 statements scored from 0-5 (0 is the least pain/no pain, 5 is the greatest level of pain). Clinical improvement is characterized by more than 10% improvement in the ODI from baseline (calculated by [total scored/total possible score]*100).

  3. Neck Disability Index (NDI) [ Time Frame: 8 weeks from baseline ]
    The most commonly-used self-report measure to gauge improvement in pain symptoms among cervical spine conditions. The NDI is comprised of 10 items (each scored on a 0-5 rating scale, in which zero reflects "no pain" and five means "worst pain imaginable") including pain, personal care, reading, lifting, headaches, concentration, work ,driving, sleeping, and recreation. A higher score indicates greater level of disability. The NDI can be scored as a raw score of doubled and expressed as a percentile. 0-4 points (0-8%) = no disability. 5-14 points (10-28%) = mild disability. 15-24 points (30-48%) = moderate disability. 25-34 points (50-64%) = severe disability. 35-50 point (70-100%) = complete disability. Clinical improvement was indicated by improvement of at least 10% from baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female at least 18 years of age.
  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:

  1. Unresolved neck or back pain from a previous cervical, thoracic or lumbar surgery at any level.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064866


Locations
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United States, California
Comprehensive Spine and Sports Center
Campbell, California, United States, 89148
Neurological Associates of West LA
Santa Monica, California, United States, 90403
The Spine Institute: Center for Spinal Restoration
Santa Monica, California, United States, 90403
Thrive Treatment
Santa Monica, California, United States, 90405
United States, Georgia
Georgia Pain and Spine
Peachtree City, Georgia, United States, 30269
United States, Illinois
Millenium Pain Center
Chicago, Illinois, United States, 61704
United States, Texas
Precision Spine Care
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Neurological Associates of West Los Angeles
EmCyte Corporation
BioRich Medical
Investigators
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Principal Investigator: Sheldon E Jordan, M.D. Neurological Associates of West Los Angeles
Publications:
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.
Marx RE. Clinical controversies in oral and maxillofacial surgery: part two. Platelet Rich Plasma: Evidence to Support Its Use 2004. doi:10.1016/j.joms.2003.12.003.

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Responsible Party: Neurological Associates of West Los Angeles
ClinicalTrials.gov Identifier: NCT04064866    
Other Study ID Numbers: 31135/1
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Neurological Associates of West Los Angeles:
Lumbar Spine
Thoracic Spine
Cervical Spine