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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05250947
Other study ID # 18-011475
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 5, 2023
Est. completion date July 2024

Study information

Verified date June 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Matthew Pingree

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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
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