Biologic Injection For Adults With Lumbar Disc Herniation

Part of paid clinical trials in Manhattan, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07386548
Status
Not Yet Recruiting

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Conditions

  • Bone Marrow Aspirate Concentrate
  • CLBP - Chronic Low Back Pain
  • Chronic Low Back Pain (CLBP)
  • DDD
  • Degenerative Disc Disease
  • Degenerative Disc Disease Lumbar
  • Degenerative Disc Disease, Lumbar
  • Disc Herniation, Lumbar
  • Intervertebral Disc Displacement
  • Low Back Pain
  • Lumbar Disc Herniation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: BMAC Group
    Administration of one 1-2cc intradiscal Bone Marrow Aspirate Concentrate (BMAC) injection during lumbar microdiscectomy surgery.
  • No Intervention: Control Group
    Standard of care lumbar microdiscectomy surgery without the BMAC injection.

Primary Outcome Measure

Change from Baseline in Intervertebral Disc Hydration at 3 Months [ Time Frame: Baseline and 3 Months post-operation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NewYork-Presbyterian/Weill Cornell Medical CenterManhattanNew York10065
Research Assistant
[email protected]
5163539723
Research Assistant
[email protected]

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By research site
NewYork-Presbyterian/Weill Cornell Medical Center· Manhattan, NY

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