Recruiting

BMAC

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07386548

Conditions

Degenerative Disc Disease

DDD

Degenerative Disc Disease Lumbar

Degenerative Disc Disease, Lumbar

Lumbar Disc Herniation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bone Marrow Aspirate Concentrate (BMAC)

Study Details

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.

Conditions

Degenerative Disc Disease

DDD

Degenerative Disc Disease Lumbar

Degenerative Disc Disease, Lumbar

Lumbar Disc Herniation

Study ID

NCT07386548

Start date

Aug 30, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Bone Marrow Aspirate Concentrate (BMAC)

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

Primary outcome measure

  • Change from Baseline in Intervertebral Disc Hydration at 3 Months [ Time Frame: Baseline and 3 Months post-operation ]
  • Change from Baseline in Intervertebral Disc Hydration at 1 Year [ Time Frame: Baseline and 1 year post-operation ]
  • Change from Baseline in Intervertebral Disc Hydration at 2 Years [ Time Frame: Baseline and 2 years post-operation ]
  • Change from Baseline in Proteoglycan Content at 3 Months [ Time Frame: From enrollment to 3 Months post-operation ]
  • Change from Baseline in Proteoglycan Content at 1 Year [ Time Frame: From enrollment to 1 year post-operation ]
  • Change from Baseline in Proteoglycan Content at 2 Years [ Time Frame: From enrollment to 2 years post-operation ]
  • Change from Baseline in Disc Height Index at 3 Months [ Time Frame: From enrollment to 3 months post-operation ]
  • Change from Baseline in Disc Height Index at 1 Year [ Time Frame: From enrollment to 1 year post-operation ]
  • Change from Baseline in Disc Height Index at 2 Years [ Time Frame: From enrollment to 2 years post-operation ]
  • Change from Baseline in Pfirrmann Grade at 3 Months [ Time Frame: From enrollment to 3 months post-operation ]
  • Change from Baseline in Pfirrmann Grade at 1 Year [ Time Frame: From enrollment to 1 year post-operation ]
  • Change from Baseline in Pfirrmann Grade at 2 Years [ Time Frame: From enrollment to 2 years post-operation ]
  • Change from Baseline in Nucleus Pulposus Size at 3 Months [ Time Frame: From enrollment to 3 months post-operation ]
  • Change from Baseline in Nucleus Pulposus Size at 1 Year [ Time Frame: From enrollment to 1 year post-operation ]
  • Change from Baseline in Nucleus Pulposus Size at 2 Years [ Time Frame: From enrollment to 2 years post-operation ]
  • Change from Baseline in NOCISCORE at 3 Months [ Time Frame: From enrollment to 3 months post-operation ]
  • Change from Baseline in NOCISCORE at 1 Year [ Time Frame: From enrollment to 1 year post-operation ]
  • Change from Baseline in NOCISCORE at 2 Years [ Time Frame: From enrollment to 2 years post-operation ]

Central Contacts and Locations

Central contacts

Research Assistant

5163539723adr4017@med.cornell.edu

Research Assistant

evw4005@med.cornell.edu

Locations

NewYork-Presbyterian/Weill Cornell Medical Center

Recruiting

Manhattan, New York, United States, 10065

Contacts

Research Assistant

5163539723adr4017@med.cornell.edu

Research Assistant

evw4005@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • degenerative disc disease
  • lumbar disc herniation
  • bone marrow aspirate concentrate
  • intervertebral disc displacement
  • low back pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-07-29.