Trials / Not Yet Recruiting
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
- 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
| Type | Name | Description |
|---|---|---|
| OTHER | Bone 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.