Safety and Efficacy of PRP for Treatment of Disc Pain

NCT04064866 | Completed FDA Device

• 1 other identifier: 31135/1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 7

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.

Conditions

Discogenic Pain

Keywords

Lumbar Spine; Thoracic Spine; Cervical Spine

Outcome Measures

Primary Outcomes (2)

• Patient Specific Functional Scale (PSFS)

  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).

  8 weeks from baseline

• Adverse Event Reporting

  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. \[NOTE: NONE REPORTED THROUGHOUT STUDY DURATION\]

  Baseline to 26 weeks

Secondary Outcomes (3)

• Numeric Pain Rating Scale (NRPS)

  8 weeks from baseline

• Oswestry Disability Index (ODI)

  8 weeks from baseline

• Neck Disability Index (NDI)

  8 weeks from baseline

Study Arms (2)

PRP/Hemocyte Autograft Intervention Arm

EXPERIMENTAL

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; Device: ProPlaz PPC

Placebo Control Arm

PLACEBO COMPARATOR

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

Interventions

High yield pure PRP DEVICE

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.

Also known as: PRP

PRP/Hemocyte Autograft Intervention Arm

Placebo OTHER

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.

Also known as: Control

Placebo Control Arm

ProPlaz PPC DEVICE

Trademarked name of an FDA-cleared product

Also known as: BioRich Medical ProPlaz Protein Plasma Concentrator

PRP/Hemocyte Autograft Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female at least 18 years of age.
• Clinically suspected discogenic pain in the cervical, thoracic or lumbar spine.
• Bring considered for discography in order to identify source of pain in the evaluation of potential surgical candidates.
• History of neck pain or mid or low back pain for at least 3 months.
• Failed to respond to conservative therapies that include physical therapy and analgesics.
• 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).

You may not qualify if:

• Unresolved neck or back pain from a previous cervical, thoracic or lumbar surgery at any level.
• Any contraindication for discography or surgery
• Significant signs or symptoms of root or cord compression at treatment levels.
• Any diagnosis of a concurrent pain disorder or other concurrent cause of disability.
• Daily opioid requirements of greater than180 mg oral morphine equivalent
• (OME) per day.
• Current active systemic infection, or history of disc infection.
• Untreated disabling thought or mood disorder.
• Inability to provide informed consent including subjects in a socially compromised condition such as prisoners.

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead
• EmCyte Corporation: collaborator
• BioRich Medical: collaborator

Study Sites (7)

Comprehensive Spine and Sports Center

Campbell, California, 89148, United States

Location

Neurological Associates of West LA

Santa Monica, California, 90403, United States

Location

The Spine Institute: Center for Spinal Restoration

Santa Monica, California, 90403, United States

Location

Thrive Treatment

Santa Monica, California, 90405, United States

Location

Georgia Pain and Spine

Peachtree City, Georgia, 30269, United States

Location

Millenium Pain Center

Chicago, Illinois, 61704, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

Related Publications (28)

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Study Officials

• Sheldon E Jordan, M.D.

  Neurological Associates of West Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 22, 2019
• Study Start: May 17, 2016
• Primary Completion: December 31, 2018
• Study Completion: February 18, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

US (7)