NCT07386548 Biologic Injection For Adults With Lumbar Disc Herniation
| NCT ID | NCT07386548 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Degenerative Disc Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-08-30 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-08-30 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Roger Hartl, MD
PRINCIPAL INVESTIGATOR
NewYork Presbyterian-Weill Cornell Medicine
Frequently Asked Questions
Who can join the NCT07386548 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Degenerative Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07386548 currently recruiting?
Yes, NCT07386548 is actively recruiting participants. Contact the research team at adr4017@med.cornell.edu for enrollment information.
Where is the NCT07386548 trial being conducted?
This trial is being conducted at Manhattan, United States.
Who is sponsoring the NCT07386548 clinical trial?
NCT07386548 is sponsored by Weill Medical College of Cornell University. The principal investigator is Roger Hartl, MD at NewYork Presbyterian-Weill Cornell Medicine. The trial plans to enroll 90 participants.