Platelet Lysate vs Saline for Lumbosacral Radiculopathy

Single-Blind, Randomized, Controlled, Crossover Study of Autologous Platelet Lysate Versus Saline in Adults With Lumbosacral Radiculopathy

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

Study Overview

• Status: Terminated
• Conditions: Lumbar Radiculopathy; Lumbosacral Radiculopathy
• Intervention / Treatment: Other: Platelet lysate; Other: Saline control

Detailed Description

This single-center, single-blind, randomized-controlled clinical trial will enroll approximately 20 participants, randomized in a 1:1 ratio to receive either autologous PL (N=10) or saline (N=10) epidural injections for patients with lumbar radiculopathy.

Prior to enrollment, patients will undergo evaluation of medical history, back pain history, lumbar examination, radicular symptoms, medication use and review lumbar spine imaging.

Treatment will consist of lumbar transforaminal epidural at affected level/side. On the morning of the procedure, all patients will undergo a blood draw to maintain blinding of study condition. Patients in the active treatment group will receive an epidural injection of platelet lysate. Patients in the control group will receive an epidural injection of saline.

Patients will be blinded to study condition until the 3-month post-treatment follow-up. After completing the 3-month surveys, the patients will be unblinded. Patients that had been in the saline control group will be given the opportunity to cross-over into the active treatment group and re-start study timeline, completing follow-up surveys at 1, 2, 3- and 6- months.

The primary objective of this study is to compare the changes in patient-reported outcomes between the 2 groups (control versus treatment) for leg pain. Secondary objectives include comparing the change scores of other patient reported outcomes of back pain and function at 3-months, as well as continued evaluation of efficacy and durability up to 6-months in active treatment group. Change scores will be calculated by taking the difference between the 3-month scores and the baseline scores. Patients will complete subject-reported clinical questionnaires at pre-treatment, 1-month, 2-months, 3-months, and 6-months (6-m questionnaires only in the active treatment group).

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Broomfield, Colorado, United States, 80021
      • Centeno-Schultz Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must be 18-65 years of age, inclusive, at time of signing informed consent
2. At least moderate pain at screening using Patient Global Impression of Severity (PGIS)
3. 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
4. Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes
5. Presence of persistent unilateral radicular pain. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities.
6. 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.
7. 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.
8. Is independent, ambulatory, and can comply with post-treatment evaluations and visits.
9. Voluntary signature of the IRB approved Informed Consent

Exclusion Criteria:

1. Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain
2. Bleeding disorders
3. Currently taking anticoagulant or immunosuppressive medication
4. Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis)
5. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.)
6. 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
7. 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
8. Has undergone a surgical procedure for back pain (e.g. discectomy, artificial disc replacement, fusion, etc)
9. Presence of spinal cord stimulator
10. Received epidural steroid injection or nerve blocks within the last 2 months
11. Use of chronic opioids
12. Documented history of drug abuse within the last 6 months
13. Use of immunosuppressants, oral or intravenous steroids in the last 3 months
14. Is pregnant
15. Allergy or intolerance to study medication (e.g. lidocaine, etc.)
16. Condition represents a worker's comp case and/or is involved in health-related litigation
17. Presence of clinically significant disease that may interfere with the evaluation of safety and other clinical outcomes in the study
18. Any other condition, that in the opinion of the investigator, would preclude the patient from enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet Lysate; Lumbar transforaminal epidural of autologous platelet lysate	Other: Platelet lysate; 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.
Placebo Comparator: Saline; Lumbar transforaminal epidural of saline	Other: Saline control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Scale (NPS)-Leg	Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain	Baseline, 1-month, 2-month, 3-month, 6-month
Numeric Pain Scale (NPS)-Back	Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain	Baseline, 1-month, 2-month, 3-month, 6-month
Mean modified SANE scores	Average SANE scores post-treatment; scores range from 0-100 where 0=no improvement and 100=100% improved	Baseline, 1-month, 2-month, 3-month, 6-month
Functional Rating Index (FRI)	Changes in FRI from pre to post treatment and between group differences at 3 months; scales 0-100% where 0%=no disability and 100%=very severe disability	Baseline, 1-month, 2-month, 3-month, 6-month
Oswestry Disability Index (ODI)	Changes in ODI from pre to post and between group differences at 3 months; scales 0-100% where 0%=no disability and 100%=very disabled.	Baseline, 1-month, 2-month, 3-month, 6-month
Patient Global Impression of Change (PGIC)	Evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status (From "Very Much Improved" to "Very Much Worse")	1-month, 2-month, 3-month, 6-month
Patient Global Impression of Severity (PGIS)	Evaluate the severity of your overall health status (From "None" to "Very Severe"	Baseline
Incidence rate of adverse events	Incidence of adverse events after treatment	1-month, 2-month, 3-month, 6-month
Incidence rate of surgical/other treatment interventions	Incidence of surgical/other treatment interventions after treatment	1-month, 2-month, 3-month, 6-month
Pain medications	Changes in medications from pre to post treatment	Baseline and 3-months

Collaborators and Investigators

• Sponsor: Regenexx, LLC

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): November 5, 2025
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: lumbosacral radicular pain; lumbar radiculopathy; lumbosacral radiculopathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: RGX2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No