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 range18 Years

SexALL

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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

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

Change from Baseline in Disc Height Index at 1 Year

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