Biologic Injection For Adults With Lumbar Disc Herniation
Recruiting
N/AInterventional Study
Degenerative Disc DiseaseDDDDegenerative Disc Disease LumbarDegenerative Disc Disease, LumbarLumbar Disc HerniationDisc Herniation, LumbarBone Marrow Aspirate ConcentrateIntervertebral Disc DisplacementLow Back PainChronic Low Back Pain (CLBP)CLBP - Chronic Low Back Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Weill Medical College of Cornell University · Other
Who this trial is looking for
This trial is looking for adults with low back pain who are scheduled for back surgery. Participants will have an injection during surgery and answer questions about their pain and recovery over two years.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with degenerative disc disease or lumbar disc herniation.
I have not improved with non-surgical treatments for more than 3 months.
I can understand and follow the study instructions.
You may not be able to join if
I am a prisoner.
I am not yet an adult.
I cannot clearly understand English.
I have major cognitive impairment.
I have an active cancer.
I have an active infection.
I have an autoimmune disorder affecting my spine.
I have had prior surgery at the same or adjacent level.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Eligibility Criteria
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 tre…
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
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