Biologic Injection For Adults With Lumbar Disc Herniation (BMAC)

Weill Cornell Medicine (WCM)

Status: Not yet enrolling

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

Treatments: Other: Bone Marrow Aspirate Concentrate (BMAC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07386548

24-09027977

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 2 patient groups

BMAC Group

Active Comparator group

Description:

Administration of one 1-2cc intradiscal Bone Marrow Aspirate Concentrate (BMAC) injection during lumbar microdiscectomy surgery.

Treatment:

Other: Bone Marrow Aspirate Concentrate (BMAC)

Control Group

No Intervention group

Description:

Standard of care lumbar microdiscectomy surgery without the BMAC injection.