Not Yet RecruitingNot Applicable

Biologic Injection For Adults With Lumbar Disc Herniation

United States90 participantsStarted 2026-05-01

Plain-language summary

The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve recovery in adults undergoing lumbar microdiscectomy for a lumbar disc herniation. The main questions it aims to answer are: * Does the BMAC injection lead to better disc tissue health after surgery (as seen on MRI scans)? * Does the BMAC injection lead to greater improvement in pain and disability compared to surgery alone? Participants will be adults aged 18 and older who are scheduled for lumbar microdiscectomy surgery. Researchers will compare one group of participants receiving the standard-of-care surgery plus the BMAC injection with another group receiving the same surgery without the injection to see if the injection offers added benefit. Participants will: * Have surgery (microdiscectomy) with or without the injection. * Complete pain and disability questionnaires at several times over 2 years. * Undergo MRI scans at baseline and follow-up to assess disc structure and tissue health. * Provide samples of leftover disc or bone-marrow tissue (as applicable) from surgery for analysis.

Who can participate

Age range

18 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: * Male or female patients ≥ 18 years of age * Clinically and/or radiographically (MRI) confirmed diagnosis of degenerative disc disease of the lumbar spine, lumbar disc herniation, and indication for lumbar microdiscectomy surgery * Unresponsive to conservative/non-operative treatment for \>3 months * Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups and observe the treatment plan Exclusion Criteria: * Prisoners * Individuals who are not yet adults (infants, children, teenagers) * Individuals who are not able to clearly understand English * Adults with diminished capacity to consent * Major cognitive impairment causing to inability to understand and provide informed consent * Active malignancy * Active chronic or acute infection * Autoimmune disorder that impacts the lumbar spine (ankylosing spondylitis, lupus e.g.) * Bone marrow-derived or non-bone marrow-derived cancer * Low platelet count or clotting disorders * Prior surgery at the level to be treated or the adjacent level

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.

1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to pursue other treatments in the meantime rather than waiting?
2The trial is measuring whether a bone marrow aspirate concentrate injection can actually restore disc hydration, proteoglycan content, and disc height over two years — how realistic is it that a single injection could reverse the structural changes in my disc, based on what's known so far?
3Since this trial has no assigned phase, what does that mean for how much safety and effectiveness data already exists for this type of biologic injection in the lumbar disc, and how should that affect my decision?
4The study tracks outcomes at 3 months, 1 year, and 2 years — given my current pain levels and daily functioning, is committing to that length of follow-up realistic for my situation, and what would happen to my care if I needed to drop out?
5Are there standard treatments — like physical therapy, epidural steroid injections, or surgery — that might be a better first step for my lumbar disc herniation before considering an experimental biologic injection like this one?

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

Change from Baseline in Intervertebral Disc Hydration at 3 Months

Timeframe: Baseline and 3 Months post-operation

Change from Baseline in Intervertebral Disc Hydration at 1 Year

Timeframe: Baseline and 1 year post-operation

Change from Baseline in Intervertebral Disc Hydration at 2 Years

Timeframe: Baseline and 2 years post-operation

Change from Baseline in Proteoglycan Content at 3 Months

Timeframe: From enrollment to 3 Months post-operation

Change from Baseline in Proteoglycan Content at 1 Year

Timeframe: From enrollment to 1 year post-operation

Change from Baseline in Proteoglycan Content at 2 Years

Timeframe: From enrollment to 2 years post-operation

Change from Baseline in Disc Height Index at 3 Months

Timeframe: From enrollment to 3 months post-operation

Trial details

NCT IDNCT07386548

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-01

Contact for this trial

Research Assistant

5163539723 adr4017@med.cornell.edu

View on ClinicalTrials.gov More Degenerative Disc Disease trials