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

Trial Summary

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.

What data supports the effectiveness of the treatment Platelet Lysate for Sciatica?

Research suggests that platelet lysate, which is rich in growth factors, has been used successfully in other treatments like promoting cell growth and tissue regeneration. This indicates potential benefits for conditions like sciatica, where tissue repair and pain relief are needed. ^{1 2 3 4 5}

How is the treatment Platelet Lysate for Sciatica different from other treatments?

Platelet lysate is unique because it is rich in growth factors like TGF-beta, EGF, and IGF, which can promote healing and reduce inflammation, potentially offering a novel approach for treating sciatica compared to traditional methods. This treatment is also virally inactivated, making it safer for clinical use. ^{2 6 7 8 9}

What is the purpose of this trial?

This is a randomized trial to evaluate and compare platelet lysate epidural injection to saline epidural injection for the treatment of lumbar radiculopathy (sciatica).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A novel virally inactivated human platelet lysate preparation rich in TGF-beta, EGF and IGF, and depleted of PDGF and VEGF. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Influence of platelet storage time on human platelet lysates and platelet lysate-expanded mesenchymal stromal cells for bone tissue engineering. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Growth-Stimulating Effect of Platelet Preparations Obtained by Different Methods on Human Fibroblast Culture. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Human platelet lysates promotes the proliferation of mesenchymal stem cells in vitro]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Composition of growth factors and cytokines in lysates obtained from fresh versus stored pathogen-inactivated platelet units. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Expansion of adipose tissue mesenchymal stromal progenitors in serum-free medium supplemented with virally inactivated allogeneic human platelet lysate. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

A double-virally-inactivated (Intercept-solvent/detergent) human platelet lysate for in vitro expansion of human mesenchymal stromal cells. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Virally inactivated human platelet concentrate lysate induces regulatory T cells and immunosuppressive effect in a murine asthma model. [2013]