Platelet Lysate for Sciatica

Overseen By Matthew Murphy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Regenexx, LLC

Must not be taking: Anticoagulants, Immunosuppressants, Opioids, Steroids

Disqualifiers: Psychological conditions, Bleeding disorders, Auto-immune pathology, others

Compensation: Varies

Number of Visits: 6

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether platelet lysate injections can reduce pain from sciatica, a condition where pain radiates from the lower back down the leg. Researchers compare the effects of platelet lysate to a saline (saltwater) injection to determine which provides better pain relief. Suitable participants have experienced sciatica symptoms for less than two years, suffer from significant leg pain or numbness, and have tried other treatments like medication or physical therapy without much success. As an unphased trial, this study offers patients the opportunity to explore a new treatment option that could potentially alleviate their sciatica pain.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking anticoagulant or immunosuppressive medications, or if you have used chronic opioids or steroids recently.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that platelet lysate injections are generally safe for treating conditions like sciatica. These injections use components of the patient's own blood and are usually well-tolerated. Reports of serious side effects are few. A review found that unwanted side effects from platelet lysate are rare. In the patients studied, no serious problems occurred. Overall, the evidence suggests that platelet lysate could be a safe option for people with lumbar radiculopathy, often known as sciatica. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about platelet lysate for sciatica because it offers a novel approach compared to standard treatments like pain medications, physical therapy, or steroid injections. Unlike these options, platelet lysate is derived from the patient's own blood, using growth factors to potentially repair nerve damage and reduce inflammation more effectively. This treatment is administered directly into the lumbar region, targeting the source of pain in a way that could lead to faster and more sustainable relief.

What evidence suggests that this trial's treatments could be effective for sciatica?

Research has shown that platelet lysate injections into the spine can effectively treat lower back pain that often resembles sciatica. Patients who received these injections reported significant pain relief. In one study, 73% of patients experienced a noticeable reduction in pain after treatment. This trial will compare the effects of platelet lysate with a saline placebo. The evidence supports platelet lysate's potential to help those suffering from sciatica find relief. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with lumbar radiculopathy (sciatica) or cervical radiculopathy. Participants should meet specific health criteria to be included, but the provided information does not detail these requirements.

Inclusion Criteria

Must have lumbar spine MRI images available after the onset of clinical symptoms and correlate with localization of clinical symptoms; CT is acceptable for patients with contraindication for MRI

Must provide voluntary signature of the IRB approved Informed Consent

I have lower spine pain not relieved by standard treatments, including medication and physical therapy.

Exclusion Criteria

Presence of spinal cord stimulator

Use of chronic opioids

Documented history of drug abuse within the last 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive lumbar transforaminal epidural injections of either platelet lysate or saline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys at 1, 2, 3, and 6 months

6 months

4 visits (in-person or virtual)

Crossover

Participants in the saline control group may cross over to receive platelet lysate and restart the study timeline

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Platelet Lysate
• Saline

Trial Overview The study is testing whether platelet lysate epidural injections are more effective than saline (saltwater) injections in treating sciatica. Patients will be randomly assigned to receive either the platelet lysate or saline.

How Is the Trial Designed?

Group I: Platelet Lysate Experimental Treatment 1 Intervention

Lumbar transforaminal epidural of autologous platelet lysate

Group II: Saline Placebo Group 1 Intervention

Lumbar transforaminal epidural of saline

Who Is Running the Clinical Trial?

Regenexx, LLC

Lead Sponsor

Trials

15

Recruited

50,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5701904/

The use of lumbar epidural injection of platelet lysate for ... Registry based data revealed PL epidural injections showed promise as an alternative treatment for lumbar radicular pain. Patients reported ...

2. painmedicinenews.com painmedicinenews.com/Interventional/Article/05-18/Platelet-Lysate-Epidural-Injections-Effectively-Treat-Lumbar-Radicular-Pain/48674?sub=13A6EABD71910B75840DB94AB8C88CA8B2FDF2363B2F18E378D35C7BF5571E1&enl=true

Platelet Lysate Epidural Injections Effectively Treat Lumbar ... Patients with lumbar radicular pain who were treated with platelet lysate epidural injections reported significant improvements in their pain, according to ...

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05725-z

Therapeutic interventions of platelet-rich plasma versus ... Growing clinical evidence suggests that PRP may serve as a promising alternative to epidural corticosteroids for lumbar radicular pain [25, 26].

4. mdpi.com mdpi.com/2227-9059/11/9/2404

Systematic Review of Platelet-Rich Plasma for Low Back ... Epidural PRP injections have demonstrated long-term safety and effectiveness, with platelet lysate injections leading to pain reduction and functional ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772594424000232

An evaluation of the effectiveness of platelet rich plasma ... At 12-months post-PRP, 4 of 11(36%) of patients had ≥50 % pain relief (95% CI: 2%, 70%) and 8 of 11(73%) had achieved minimal clinically important difference ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10525951/

Systematic Review of Platelet-Rich Plasma for Low Back Pain Epidural PRP injections have demonstrated long-term safety and effectiveness, with platelet lysate injections leading to pain reduction and functional ...

7. trialx.com trialx.com/clinical-trials/listings/300807/platelet-lysate-vs-saline-for-lumbosacral-radiculopathy/

Platelet Lysate vs Saline for Lumbosacral Radiculopathy This is a randomized trial to evaluate and compare platelet lysate epidural injection to saline epidural injection for the treatment of lumbar ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0753332224013933

Effectiveness of platelet derivatives in neuropathic pain ... A high safety profile was reported with no serious adverse effects in the analysed patients. Conclusion. PRP treatment might be an effective therapeutic ...