TerminatedNot Applicable

Platelet Lysate vs Saline for Lumbosacral Radiculopathy

Stopped: Slow enrollment

United States2 participantsStarted 2025-07-01

Plain-language 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).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numeric Pain Scale (NPS)-Leg

Timeframe: 3-months

Trial details

NCT IDNCT06924853

SponsorRegenexx, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-05

View on ClinicalTrials.gov More Lumbosacral Radiculopathy trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Platelet Lysate vs Saline for Lumbosacral Radiculopathy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Platelet Lysate vs Saline for Lumbosacral Radiculopathy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria