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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 22 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
  • - Prior history of lumbar procedure.
  • - Redness, swelling, rash or other concerning lesions at the injection site just prior to the procedure.
  • - Prior history of allergy to lidocaine or other local anesthetic agent.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05250947
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Matthew Pingree
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Matthew Pingree, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lumbar Spondylosis
Study Website: View Trial Website
Additional Details

This study is a pilot of the safety of using the FDA cleared Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set to process PRP to treat arthritis of the low back (lumbar spondylosis). Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 12 months. A final visit for evaluation and collection of lab samples will be conducted at the end of the study.

Arms & Interventions

Arms

Experimental: PRP Injection Arm

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.

Interventions

Device: - Angel® Concentrated Platelet Rich Plasma System

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905