Safety and Efficacy of PRP for Treatment of Disc Pain

Discogenic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064866
• Other study ID #: 31135/1
• Status: Completed
• Phase: N/A
• Start date: May 17, 2016
• Est. completion date: February 18, 2019

Study information

• Verified date: December 2019
• Source: Neurological Associates of West Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 18, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Discogenic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Comprehensive Spine and Sports Center	Campbell	California
United States	Millenium Pain Center	Chicago	Illinois
United States	Georgia Pain and Spine	Peachtree City	Georgia
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	Precision Spine Care	Tyler	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Neurological Associates of West Los Angeles	BioRich Medical, EmCyte Corporation

Country where clinical trial is conducted

United States, 

References & Publications (28)

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Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM R. 2016 Jan;8(1):1-10; quiz 10. doi: 10.1016/j.pmrj.2015.08.010. Epub 2015 Aug 24. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Numeric Pain Rating Scale (NRPS)	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)	8 weeks from baseline
Secondary	Oswestry Disability Index (ODI)	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).	8 weeks from baseline
Secondary	Neck Disability Index (NDI)	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.	8 weeks from baseline