Platelet Lysate vs Saline for Lumbosacral Radiculopathy

NCT06924853 | Terminated

• 1 other identifier: RGX2025-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lumbosacral Radiculopathy; Lumbar Radiculopathy

Keywords

lumbosacral radiculopathy; lumbosacral radicular pain; lumbar radiculopathy

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Scale (NPS)-Leg

  Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain in regard to leg pain

  3-months

Secondary Outcomes (10)

• Numeric Pain Scale (NPS)-Leg

  Baseline, 1-month, 2-month, 3-month, 6-month

• Numeric Pain Scale (NPS)-Back

  Baseline, 1-month, 2-month, 3-month, 6-month

• Mean modified SANE scores

  Baseline, 1-month, 2-month, 3-month, 6-month

• Functional Rating Index (FRI)

  Baseline, 1-month, 2-month, 3-month, 6-month

• Oswestry Disability Index (ODI)

  Baseline, 1-month, 2-month, 3-month, 6-month

Study Arms (2)

Platelet Lysate

EXPERIMENTAL

Lumbar transforaminal epidural of autologous platelet lysate

Other: Platelet lysate

Saline

PLACEBO COMPARATOR

Lumbar transforaminal epidural of saline

Other: Saline control

Interventions

Platelet lysate OTHER

The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis (Beckman Coulter DxH 500 Series). Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. Once flow is confirmed, the physician will inject 4mL of the PL, and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest. A 0.22 micron filter will be used.

Platelet Lysate

Saline control OTHER

The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis; same as active treatment to maintain blinding. Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. (6) Once flow is confirmed, the physician will inject 4mL of sterile saline (0.9%), and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest.

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18-65 years of age, inclusive, at time of signing informed consent
• At least moderate pain at screening using Patient Global Impression of Severity (PGIS)
• Diagnosis of lumbosacral radiculopathy (LSR) radiating to or below the knee in a single dermatomal pattern (L4, L5, or S1) with onset of clinical symptoms less than 2 year prior to screening visit
• Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes
• Presence of persistent unilateral radicular pain. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities.
• LSR pain with inadequate response to conservative care (non-operative); participants must have tried at least one anti-inflammatory or analgesic medication (for at least 2 weeks at adequate doses) and at least one of the following: Physical therapy, bed rest, chiropractic manipulations, home directed lumbar and/or exercise programs.
• Lumbar spine MRI images are available after the onset of clinical symptoms and correlate with localization of clinical symptoms. CT is acceptable for patients with contraindication for MRI.
• Is independent, ambulatory, and can comply with post-treatment evaluations and visits.
• Voluntary signature of the IRB approved Informed Consent

You may not qualify if:

• Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain
• Bleeding disorders
• Currently taking anticoagulant or immunosuppressive medication
• Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis)
• Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.)
• Co-existing hip or knee pain localized to the joint structures that may interfere with the participant's ability to participate in the study or interfere with pain assessments
• Any central canal stenosis with neurogenic claudication (not including foraminal stenosis) with pain present mostly during walking and signs of lumbar stenosis on lumbar spine MRI/CT
• Has undergone a surgical procedure for back pain (e.g. discectomy, artificial disc replacement, fusion, etc)
• Presence of spinal cord stimulator
• Received epidural steroid injection or nerve blocks within the last 2 months
• Use of chronic opioids
• Documented history of drug abuse within the last 6 months
• Use of immunosuppressants, oral or intravenous steroids in the last 3 months
• Is pregnant
• Allergy or intolerance to study medication (e.g. lidocaine, etc.)

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (1)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Related Publications (5)

• Williams C, Jerome M, Fausel C, Dodson E, Stemper I, Centeno C. Regenerative Injection Treatments Utilizing Platelet Products and Prolotherapy for Cervical Spine Pain: A Functional Spinal Unit Approach. Cureus. 2021 Oct 8;13(10):e18608. doi: 10.7759/cureus.18608. eCollection 2021 Oct.

  PMID: 34659923 BACKGROUND

• Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.

  PMID: 17445735 BACKGROUND

• Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM R. 2016 Jan;8(1):1-10; quiz 10. doi: 10.1016/j.pmrj.2015.08.010. Epub 2015 Aug 24.

  PMID: 26314234 BACKGROUND

• Capelli C, Domenghini M, Borleri G, Bellavita P, Poma R, Carobbio A, Mico C, Rambaldi A, Golay J, Introna M. Human platelet lysate allows expansion and clinical grade production of mesenchymal stromal cells from small samples of bone marrow aspirates or marrow filter washouts. Bone Marrow Transplant. 2007 Oct;40(8):785-91. doi: 10.1038/sj.bmt.1705798. Epub 2007 Aug 6.

  PMID: 17680021 BACKGROUND

• Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.

  PMID: 29177632 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients are randomized either to active treatment or control group. Patients in control group can crossover to treatment group after 3-month time point.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: July 1, 2025
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)