Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain

NCT05250947 | Terminated Phase 1 FDA Drug FDA Device

• 1 other identifier: 18-011475
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to assess the safety of using the Angel Concentrated Platelet Rich Plasma System to process Platelet Rich Plasma (PRP) to treat arthritis of the low back (lumbar spondylosis).

Conditions

Lumbar Spondylosis

Keywords

arthritis; facet joint; lumbar spondylosis; back pain

Outcome Measures

Primary Outcomes (2)

• Number of adverse device effects

  Adverse device effects related to the processing of the platelet rich plasma product (such as hardware failures/malfunctions, software errors, disposable set equipment malfunctions, processing errors, automatic self-test/calibration errors, variations in hematocrit level in final product, variations in total volume of PRP concentrate produced, etc.)

  Day 0 (Day of procedure)

• Number of suspected acute adverse reactions to the treatment

  Suspected adverse reactions to the treatment based on evaluations including follow-up physical examinations, labs and assessment of clinical signs and symptoms.

  Day 0 to Day 14

Study Arms (1)

PRP Injection Arm

EXPERIMENTAL

The FDA cleared Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set will be used to process the PRP. The targeted final PRP volume of 6 ml will be injected in up to 4 facet joints (2 levels) at 1.5 ml per joint.

Device: Angel® Concentrated Platelet Rich Plasma System; Drug: Platelet Rich Plasma

Interventions

Angel® Concentrated Platelet Rich Plasma System DEVICE

Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set will be used to process the PRP.

PRP Injection Arm

Platelet Rich Plasma DRUG

6 ml will be injected in up to 4 facet joints (2 levels) at 1.5 ml per joint

PRP Injection Arm

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and radiographic (MRI, CT or lumbar x-ray) evidence of symptomatic facet arthropathy involving the bilateral bottom two facets (e.g., L4-5 or L5-6 and L5-S1 or L6-S1).
• Positive response, defined according to current clinical standards for the diagnosis of facet-mediated low back pain as greater than or equal to 75% pain improvement (as reported by patient) to diagnostic medial branch nerve blocks, one block with lidocaine and the other with bupivacaine.
• Low back pain VAS score of greater than or equal to 5 at the clinical visit just prior to the first medial branch nerve block.

You may not qualify if:

• Prior facet related procedure (intraarticular corticosteroid injection, radiofrequency ablation (RFA)) in last 6 months or prior fusion in the bottom two facets.
• Current opioid use of greater than 50mg oral morphine milligram equivalents per day.
• No advanced imaging (MRI, CT or lumbar x-ray) of the lumbar spine within the last 6 months.
• BMI \> 34.99 (WHO class I obesity).
• Active systemic or local infection as evidenced by fever \>100.4 degrees Fahrenheit, or any other clinical signs or symptoms of infection within 24 hours of the procedure.
• On anticoagulation drug and has been on hold for less than 7 days prior to the investigational procedure.
• Imaging evidence of high likelihood of failure for intra-articular injection in the opinion of the PI or delegate review of MRI, CT or lumbar x-ray imaging.
• History of chronic thrombocytopenia (or pre-operative platelet count less than 195,000 per μl).
• Undergoing chemotherapy at time of injection.
• Pregnant or breastfeeding.
• Use of illicit drugs within 30 days prior to study entry.
• NSAID use during the pre-procedural period (one week before Treatment Day 0).
• Preoperative hematocrit less than 36%.
• History of hemodynamic instability or inability to maintain stable oncotic pressure.
• History of prolonged clotting times.

Sponsors & Collaborators

• Matthew Pingree: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Spondylosis; Arthritis; Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Pingree, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a pilot safety study.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 22, 2022
• Study Start: January 5, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)