What side effects are associated with this type of intervention?

Common treatments for Lumbar Spondylosis, such as PRP therapy, can cause side effects like pain at the injection site, infection, and tissue damage. NSAIDs may lead to gastrointestinal issues, cardiovascular problems, and kidney damage, while corticosteroid injections can result in joint infection, nerve damage, and tendon weakening. Physical therapy is generally safe but may cause temporary pain or discomfort.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for the treatment of lumbar spondylosis using the Angel Concentrated Platelet Rich Plasma System or similar PRP-based treatments. However, PRP is being studied for its potential to deliver growth factors that aid in tissue repair and reduce inflammation, which could be beneficial for conditions like lumbar spondylosis. Broadly, PRP and other growth factor therapies are being investigated for various musculoskeletal conditions, but specific FDA approvals for lumbar spondylosis were not detailed in the context.

What other types of research exist?

Promising alternatives to the Angel Concentrated Platelet Rich Plasma System for lumbar spondylosis include: 1) Anterior Vertebral Body Tethering, which modulates spinal growth and has shown efficacy in scoliosis treatment; 2) Autologous Fat Grafting mixed with Platelet-Rich Plasma, which has been used in aesthetic surgery and may enhance tissue repair; 3) Spinal Cord Stimulation, which can manage chronic pain associated with spinal conditions. These alternatives offer different mechanisms for addressing tissue repair and inflammation.

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Platelet Rich Plasma

Platelet-rich Plasma for Lower Back Pain

Phase 1

Waitlist Available

Led By Matthew Pingree, MD

Research Sponsored by Matthew Pingree

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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.

Must not have

Redness, swelling, rash or other concerning lesions at the injection site just prior to the procedure

History of hemodynamic instability or inability to maintain stable oncotic pressure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 to day 14

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for people with lower back arthritis. The treatment uses a special system to concentrate a part of the patient's own blood and inject it into their lower back. The goal is to see if this can help reduce pain and improve healing. The study will monitor patients over time to assess safety and effectiveness.

Who is the study for?

This trial is for adults with significant low back pain from arthritis in the lower spine, confirmed by clinical and imaging tests. Participants must have had a strong positive response to diagnostic nerve blocks. Exclusions include recent illicit drug use, prior lumbar procedures, allergies to local anesthetics, certain medication use including anticoagulants and NSAIDs, pregnancy or breastfeeding, ongoing chemotherapy or opioid use over a set limit.

What is being tested?

The study is testing the Angel Concentrated Platelet Rich Plasma System's safety when used to treat facetogenic low back pain caused by arthritis. The system processes PRP which is then injected into the patient's lower back area affected by arthritis.

What are the potential side effects?

While specific side effects of PRP are not detailed here, common ones may include pain at injection site, infection risk increase due to needle insertion into skin and tissue inflammation as body reacts to treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lower back pain level is 5 or higher on the pain scale.

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I experienced significant pain relief from my lower back pain after two specific nerve block injections.

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I have back pain due to arthritis in my lower spine.

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I have a low back pain score of 5 or more.

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I have back pain confirmed by scans to be due to facet joint problems in the lower spine.

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I experienced a significant pain reduction from nerve block treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have redness, swelling, or a rash at the injection site.

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I have had issues with blood pressure stability or maintaining fluid balance.

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I have not had a fever or signs of infection in the last 24 hours.

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I am currently receiving chemotherapy.

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I have had surgery on my lower back before.

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I take more than 50mg of pain medication daily.

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I've had a back procedure or injection in the last 6 months or a fusion in the lower back.

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I have a history of low platelet counts or my count is below 195,000.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 to day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 to day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of adverse device effects

Number of suspected acute adverse reactions to the treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRP Injection ArmExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet Rich Plasma

2016

Completed Phase 4

~1100

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Platelet-Rich Plasma (PRP) therapy is a promising treatment for Lumbar Spondylosis, involving the injection of concentrated platelets from the patient's own blood into the affected area. The platelets release growth factors that promote tissue repair and reduce inflammation, addressing the degenerative changes and inflammation characteristic of Lumbar Spondylosis. This can lead to pain relief and improved function. Other common treatments include physical therapy, which strengthens and stabilizes the spine, and medications like NSAIDs that reduce inflammation and pain. These treatments collectively aim to manage symptoms and improve the quality of life for patients.

Do Regenerative Medicine Therapies Provide Long-Term Relief in Chronic Low Back Pain: A Systematic Review and Metaanalysis.Differential patient responses to spinal manipulative therapy and their relation to spinal degeneration and post-treatment changes in disc diffusion.Cell therapy for the degenerating intervertebral disc.