Clinical trial for Degenerative Disc Disease
Official title Biologic Injection For Adults With Lumbar Disc Herniation
ClinicalTrials.gov ID: NCT07386548
What this study is testing
- What it's testing
- This study is testing whether adding a bone‑marrow concentrate injection during lumbar microdiscectomy improves disc health and reduces pain and disability compared to surgery alone.
- Who it's for
- You may be able to join if you are 18 or older and scheduled for lumbar microdiscectomy surgery for a herniated disc.
- What's involved
- You will have your usual surgery, and you may receive a bone‑marrow concentrate injection. You will fill out pain and disability questionnaires several times over two years and have MRI scans at the start and later to see how your disc looks. You may also give a small sample of leftover tissue from the surgery for analysis.
- Time commitment
- The study lasts about two years, with regular visits for questionnaires and MRI scans, plus your surgery day.
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Manhattan, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Manhattan, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.