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Not Yet RecruitingNCT07386548

Biologic Injection For Adults With Lumbar Disc Herniation

Bone Marrow Aspirate Concentrate Injection With MRI's - A Prospective Randomized Control Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Weill Medical College of Cornell University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERBone Marrow Aspirate Concentrate (BMAC)Dosage Form: Autologous intradiscal injection Dosage: 1-2 cc's Frequency: Once, during surgery Duration: N/A

Timeline

Start date
2026-05-01
Primary completion
2030-01-01
Completion
2030-12-01
First posted
2026-02-04
Last updated
2026-04-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07386548. Inclusion in this directory is not an endorsement.