What side effects are associated with this type of intervention?

Common treatments for Degenerative Disc Disease (DDD) include Platelet-Rich Plasma (PRP) therapy, corticosteroid injections, prolotherapy, and surgical interventions. PRP therapy is generally well-tolerated but may cause temporary pain at the injection site, swelling, and, rarely, infection. Corticosteroid injections can lead to side effects such as increased pain, infection, and potential weakening of tendons and bones with repeated use. Prolotherapy, which involves injecting irritants to stimulate healing, may cause temporary pain, swelling, and stiffness. Surgical treatments, such as spinal fusion or disc replacement, carry risks of infection, bleeding, nerve damage, and complications related to anesthesia.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Degenerative Disc Disease that are similar to Platelet-Rich Plasma (PRP) therapy in the provided context. However, PRP therapy itself is being studied for its potential benefits in treating DDD by promoting healing and regeneration through the release of growth factors and cytokines.

What other types of research exist?

Promising novel alternatives to PRP for Degenerative Disc Disease patients include: 1) Stem cell therapy, which aims to regenerate damaged disc tissue through the differentiation of stem cells into necessary cell types. 2) Fibroblast Growth Factor-18 (FGF-18), which has shown potential in stimulating chondrogenesis and cartilage repair. 3) Bone Morphogenetic Protein-7 (BMP-7), which is being investigated for its safety and efficacy in symptomatic knee osteoarthritis and may have applications in DDD. These therapies are still under investigation but represent potential advancements in the treatment of DDD.

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Platelet-based Treatment

Platelet Therapy for Degenerative Disc Disease

N/A

Recruiting

Led By Christopher Centeno, MD

Research Sponsored by Regenexx, LLC

Eligibility Criteria Checklist

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

Must have

Voluntary signature of the IRB approved Informed Consent

Skeletally mature Male or Female ages 25 to 65

Timeline

Screening 5 days

Treatment Varies

Follow Up 12 months

Summary

This trial is testing a treatment that uses a part of the patient's own blood to help heal damaged spinal discs. It targets patients with back pain due to degenerative disc disease. The treatment aims to use the body's natural healing cells to reduce pain and improve function.

Who is the study for?

This trial is for adults aged 25 to 65 with painful Degenerative Disc Disease confirmed by MRI and physical exam, who have not improved after specific back pain treatments and are potential candidates for lumbar surgery. It excludes smokers, those with untreated psychological conditions contributing to chronic pain, inflammatory diseases like rheumatoid arthritis, recent steroid injections, anticoagulant or immunosuppressive medication users, opioid users or drug abuse history within six months.

What is being tested?

The study tests two platelet-based treatments: Platelet-rich plasma (PRP) and Platelet lysate (PL), against a sham procedure (a fake treatment that seems real) in patients with degenerative disc disease. Treatments are given four weeks apart to see which is more effective at relieving back pain.

What are the potential side effects?

While the trial information does not specify side effects, common ones from similar procedures may include temporary increase in back pain, infection risk at injection site, nerve damage risks associated with spine procedures and possible allergic reactions to the substances used.

Eligibility Criteria

Inclusion Criteria

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

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I am between 25 and 65 years old.

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I have back pain due to disc disease without major spine alignment issues.

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I have chronic back or leg pain that hasn't improved with standard treatments for over 6 months.

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My MRI and physical exam show I have painful degenerative disc disease.

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I am a candidate for lumbar spine surgery.

Timeline

Screening ~ 5 days1 visit

Treatment ~ Varies

Follow Up ~ 12 months2 visits

Screening ~ 5 days

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 5 days for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Modified Single Assessment Numerical Evaluation (SANE) scores

Secondary study objectives

Functional Rating Index (FRI)

Incidence rate of adverse events

Incidence rate of surgical/other treatment interventions

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Platelet treatmentExperimental Treatment1 Intervention

A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP).

Group II: Sham procedurePlacebo Group1 Intervention

A series of two sham procedures spaced 4 weeks apart.

0 / 6Eligibility 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 for Degenerative Disc Disease works by promoting healing and regeneration through the release of growth factors and cytokines, which can enhance tissue repair and reduce inflammation. This is crucial for DDD patients as it may alleviate pain and improve spinal function. Other common treatments include physical therapy, which strengthens the muscles supporting the spine, and surgical options like spinal fusion, which stabilizes the affected vertebrae to reduce pain and improve mobility.