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Biologic Injection For Adults With Lumbar Disc Herniation

NCT07386548 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-29

No results posted yet for this study

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

OTHER

Bone Marrow Aspirate Concentrate (BMAC)

Dosage Form: Autologous intradiscal injection Dosage: 1-2 cc's Frequency: Once, during surgery Duration: N/A

Sponsors & Collaborators

  • Aclarion

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Roger Hartl, MD · NewYork Presbyterian-Weill Cornell Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2030-01-31
Completion
2030-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386548 on ClinicalTrials.gov