Biologic Injection For Adults With Lumbar Disc Herniation
RecruitingNot applicableNCT07386548
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Bone Marrow Aspirate Concentrate Injection With MRI's - A Prospective Randomized Control Trial
- Conditions
- Degenerative Disc Disease
- DDD
- Degenerative Disc Disease Lumbar
- Degenerative Disc Disease, Lumbar
- Lumbar Disc Herniation
- Disc Herniation, Lumbar
- Bone Marrow Aspirate Concentrate
- Intervertebral Disc Displacement
- Low Back Pain
- Chronic Low Back Pain (CLBP)
- CLBP - Chronic Low Back Pain
- Interventions
- Other: Bone Marrow Aspirate Concentrate (BMAC)
- Sponsor
- Weill Medical College of Cornell University
- Collaborators
- Aclarion
- Start date
- 2026-08-30
- Primary completion
- 2030-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07386548