Degenerative Disc DiseaseBMACNCT07386548
Biologic Injection For Adults With Lumbar Disc Herniation
A study testing Bone Marrow Aspirate Concentrate (BMAC) in people with Degenerative Disc Disease and DDD, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, DDD, Degenerative Disc Disease Lumbar
- What is being tested?
- Bone Marrow Aspirate Concentrate (BMAC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Assistant contact
United States1 site, 1 recruiting
- Recruiting
NewYork-Presbyterian/Weill Cornell Medical Center
Manhattan, New York, 10065
Research Assistant, 5163539723, adr4017@med.cornell.edu
Research Assistant, evw4005@med.cornell.edu
About this study
Official title: Bone Marrow Aspirate Concentrate Injection With MRI's - A Prospective Randomized Control Trial
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:
Read more
- 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
- Being tested
- Bone Marrow Aspirate Concentrate (BMAC)
- Keywords
- degenerative disc disease, lumbar disc herniation, bone marrow aspirate concentrate, intervertebral disc displacement, low back pain
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Aspirate Concentrate (BMAC)Other
Also called Bone Marrow Aspirate (BMA), Bone Marrow Aspirate Stem Cell Concentrate (BMAC), Bone Marrow Concentrate (BMC)
Dosage Form: Autologous intradiscal injection Dosage: 1-2 cc's Frequency: Once, during surgery Duration: N/A
| Study group | Role | What they receive |
|---|---|---|
| BMAC Group | Active comparator | Administration of one 1-2cc intradiscal Bone Marrow Aspirate Concentrate (BMAC) injection during lumbar microdiscectomy surgery. Receives: Other: Bone Marrow Aspirate Concentrate (BMAC) |
| Control Group | No intervention | Standard of care lumbar microdiscectomy surgery without the BMAC injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Intervertebral Disc Hydration at 3 Months
MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.
Measured: Baseline and 3 Months post-operation
Change from Baseline in Intervertebral Disc Hydration at 1 Year
MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.
Measured: Baseline and 1 year post-operation
Change from Baseline in Intervertebral Disc Hydration at 2 Years
MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.
Measured: Baseline and 2 years post-operation
Change from Baseline in Proteoglycan Content at 3 Months
MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.
Measured: From enrollment to 3 Months post-operation
Change from Baseline in Proteoglycan Content at 1 Year
MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.
Measured: From enrollment to 1 year post-operation
Change from Baseline in Proteoglycan Content at 2 Years
MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.
Measured: From enrollment to 2 years post-operation
Change from Baseline in Disc Height Index at 3 Months
Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.
Measured: From enrollment to 3 months post-operation
Change from Baseline in Disc Height Index at 1 Year
Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.
Measured: From enrollment to 1 year post-operation
Change from Baseline in Disc Height Index at 2 Years
Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.
Measured: From enrollment to 2 years post-operation
Change from Baseline in Pfirrmann Grade at 3 Months
Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs:
Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus.
Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus.
Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity.
Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity.
Grade V: End-stage degeneration with a collapsed disc and no visible nucleus
Measured: From enrollment to 3 months post-operation
Change from Baseline in Pfirrmann Grade at 1 Year
Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs:
Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus.
Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus.
Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity.
Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity.
Grade V: End-stage degeneration with a collapsed disc and no visible nucleus
Measured: From enrollment to 1 year post-operation
Change from Baseline in Pfirrmann Grade at 2 Years
Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs:
Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus.
Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus.
Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity.
Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity.
Grade V: End-stage degeneration with a collapsed disc and no visible nucleus
Measured: From enrollment to 2 years post-operation
Change from Baseline in Nucleus Pulposus Size at 3 Months
The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.
Measured: From enrollment to 3 months post-operation
Change from Baseline in Nucleus Pulposus Size at 1 Year
The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.
Measured: From enrollment to 1 year post-operation
Change from Baseline in Nucleus Pulposus Size at 2 Years
The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.
Measured: From enrollment to 2 years post-operation
Change from Baseline in NOCISCORE at 3 Months
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan.
The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.
Measured: From enrollment to 3 months post-operation
Change from Baseline in NOCISCORE at 1 Year
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan.
The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.
Measured: From enrollment to 1 year post-operation
Change from Baseline in NOCISCORE at 2 Years
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan.
The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.
Measured: From enrollment to 2 years post-operation
Secondary outcomes (11)
Change from Baseline in Patient Reported Pain at 3 Months
The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: From enrollment to 3 Months post-operation
Change from Baseline in Patient Reported Pain at 6 Months
The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: From enrollment to 6 Months post-operation
Change from Baseline in Patient Reported Pain at 1 Year
The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: From enrollment to 1 Year post-operation
Change from Baseline in Patient Reported Pain at 2 Years
The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: From enrollment to 2 years post-operation
Change from Baseline in Patient Reported Disability at 3 Months
The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).
Measured: From enrollment to 3 Months post-operation
Change from Baseline in Patient Reported Disability at 6 Months
The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).
Measured: From enrollment to 6 Months post-operation
Change from Baseline in Patient Reported Disability at 1 Year
The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).
Measured: From enrollment to 1 year post-operation
Change from Baseline in Patient Reported Disability at 2 Years
The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).
Measured: From enrollment to 2 years post-operation
Change from Baseline in SI-Score at 3 Months
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan.
The SI-Score (Structural Integrity Score) reflects the relative amounts of proteoglycan between discs as an indication of relative structural integrity between the discs on a scale from 0 to 1. Higher SI scores reflect higher relative values as compared between discs in the patient and do not necessarily reflect high structural integrity. A low SI score, corresponding to a lower structural integrity, is associated with more advanced degeneration (relative between discs).
Measured: From enrollment to 3 months post-operation
Change from Baseline in SI-Score at 1 Year
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan.
The SI-Score (Structural Integrity Score) reflects the relative amounts of proteoglycan between discs as an indication of relative structural integrity between the discs on a scale from 0 to 1. Higher SI scores reflect higher relative values as compared between discs in the patient and do not necessarily reflect high structural integrity. A low SI score, corresponding to a lower structural integrity, is associated with more advanced degeneration (relative between discs).
Measured: From enrollment to 1 year post-operation
Change from Baseline in SI-Score at 2 Years
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan.
The SI-Score (Structural Integrity Score) reflects the relative amounts of proteoglycan between discs as an indication of relative structural integrity between the discs on a scale from 0 to 1. Higher SI scores reflect higher relative values as compared between discs in the patient and do not necessarily reflect high structural integrity. A low SI score, corresponding to a lower structural integrity, is associated with more advanced degeneration (relative between discs).
Measured: From enrollment to 2 years post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start30 Aug 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Aclarion
- Responsible party
- Sponsor
- Investigators
- Roger Hartl, MD, Principal investigator, NewYork Presbyterian-Weill Cornell Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386548
- Sponsor's protocol ID
- 24-09027977
- Acronym
- BMAC
- Status last verified
- Jul 2026
- First submitted
- 27 Jan 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Zhang W, Sun T, Li Y, Yang M, Zhao Y, Liu J, Li Z. Application of stem cells in the repair of intervertebral disc degeneration. Stem Cell Res Ther. 2022 Feb 11;13(1):70. doi: 10.1186/s13287-022-02745-y.
PubMed 35148808Elabd C, Centeno CJ, Schultz JR, Lutz G, Ichim T, Silva FJ. Intra-discal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study. J Transl Med. 2016 Sep 1;14(1):253. doi: 10.1186/s12967-016-1015-5.
PubMed 27585696Mochida J, Sakai D, Nakamura Y, Watanabe T, Yamamoto Y, Kato S. Intervertebral disc repair with activated nucleus pulposus cell transplantation: a three-year, prospective clinical study of its safety. Eur Cell Mater. 2015 Mar 20;29:202-12; discussion 212. doi: 10.22203/ecm.v029a15.
PubMed 25794529Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Gonzalez-Vallinas M, Sanchez A, Garcia-Sancho J. Treatment of Degenerative Disc Disease With Allogeneic Mesenchymal Stem Cells: Long-term Follow-up Results. Transplantation. 2021 Feb 1;105(2):e25-e27. doi: 10.1097/TP.0000000000003471. No abstract available.
PubMed 33492116Jerome MA, Lutz C, Lutz GE. Risks of Intradiscal Orthobiologic Injections: A Review of the Literature and Case Series Presentation. Int J Spine Surg. 2021 Apr;15(s1):26-39. doi: 10.14444/8053. Epub 2021 Apr 21.
PubMed 34376494Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845.
PubMed 25187512Yoshikawa T, Ueda Y, Miyazaki K, Koizumi M, Takakura Y. Disc regeneration therapy using marrow mesenchymal cell transplantation: a report of two case studies. Spine (Phila Pa 1976). 2010 May 15;35(11):E475-80. doi: 10.1097/BRS.0b013e3181cd2cf4.
PubMed 20421856Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011 Oct 15;92(7):822-8. doi: 10.1097/TP.0b013e3182298a15.
PubMed 21792091Comella K, Silbert R, Parlo M. Effects of the intradiscal implantation of stromal vascular fraction plus platelet rich plasma in patients with degenerative disc disease. J Transl Med. 2017 Jan 13;15(1):12. doi: 10.1186/s12967-016-1109-0.
PubMed 28086781
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Aspirate Concentrate Injection With MRI's - A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07386548
- Acronym / sponsor ID
- BMAC / 24-09027977
- Conditions
- Degenerative Disc Disease, DDD, Degenerative Disc Disease Lumbar, Degenerative Disc Disease, Lumbar, Lumbar Disc Herniation, Disc Herniation, Lumbar
- Keywords
- degenerative disc disease, lumbar disc herniation, bone marrow aspirate concentrate, intervertebral disc displacement, low back pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Aclarion
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMAC Group | Active comparator | Other: Bone Marrow Aspirate Concentrate (BMAC)Administration of one 1-2cc intradiscal Bone Marrow Aspirate Concentrate (BMAC) injection during lumbar microdiscectomy surgery. |
| Control Group | No intervention | –Standard of care lumbar microdiscectomy surgery without the BMAC injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC)Also: Bone Marrow Aspirate (BMA), Bone Marrow Aspirate Stem Cell Concentrate (BMAC), Bone Marrow Concentrate (BMC)Dosage Form: Autologous intradiscal injection Dosage: 1-2 cc's Frequency: Once, during surgery Duration: N/A | Other | BMAC Group |
Primary outcome
Change from Baseline in Intervertebral Disc Hydration at 3 Months
Time frame: Baseline and 3 Months post-operation
MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.
Change from Baseline in Intervertebral Disc Hydration at 1 Year
Time frame: Baseline and 1 year post-operation
MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.
Change from Baseline in Intervertebral Disc Hydration at 2 Years
Time frame: Baseline and 2 years post-operation
MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.
Change from Baseline in Proteoglycan Content at 3 Months
Time frame: From enrollment to 3 Months post-operation
MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.
Change from Baseline in Proteoglycan Content at 1 Year
Time frame: From enrollment to 1 year post-operation
MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.
Change from Baseline in Proteoglycan Content at 2 Years
Time frame: From enrollment to 2 years post-operation
MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.
Change from Baseline in Disc Height Index at 3 Months
Time frame: From enrollment to 3 months post-operation
Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.
Change from Baseline in Disc Height Index at 1 Year
Time frame: From enrollment to 1 year post-operation
Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.
Change from Baseline in Disc Height Index at 2 Years
Time frame: From enrollment to 2 years post-operation
Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.
Change from Baseline in Pfirrmann Grade at 3 Months
Time frame: From enrollment to 3 months post-operation
Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs: Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus. Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus. Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity. Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity. Grade V: End-stage degeneration with a collapsed disc and no visible nucleus
Change from Baseline in Pfirrmann Grade at 1 Year
Time frame: From enrollment to 1 year post-operation
Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs: Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus. Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus. Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity. Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity. Grade V: End-stage degeneration with a collapsed disc and no visible nucleus
Change from Baseline in Pfirrmann Grade at 2 Years
Time frame: From enrollment to 2 years post-operation
Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs: Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus. Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus. Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity. Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity. Grade V: End-stage degeneration with a collapsed disc and no visible nucleus
Change from Baseline in Nucleus Pulposus Size at 3 Months
Time frame: From enrollment to 3 months post-operation
The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.
Change from Baseline in Nucleus Pulposus Size at 1 Year
Time frame: From enrollment to 1 year post-operation
The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.
Change from Baseline in Nucleus Pulposus Size at 2 Years
Time frame: From enrollment to 2 years post-operation
The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.
Change from Baseline in NOCISCORE at 3 Months
Time frame: From enrollment to 3 months post-operation
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.
Change from Baseline in NOCISCORE at 1 Year
Time frame: From enrollment to 1 year post-operation
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.
Change from Baseline in NOCISCORE at 2 Years
Time frame: From enrollment to 2 years post-operation
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.
11 secondary outcomes
Change from Baseline in Patient Reported Pain at 3 Months
Time frame: From enrollment to 3 Months post-operation
Change from Baseline in Patient Reported Pain at 6 Months
Time frame: From enrollment to 6 Months post-operation
Change from Baseline in Patient Reported Pain at 1 Year
Time frame: From enrollment to 1 Year post-operation
Change from Baseline in Patient Reported Pain at 2 Years
Time frame: From enrollment to 2 years post-operation
Change from Baseline in Patient Reported Disability at 3 Months
Time frame: From enrollment to 3 Months post-operation
Change from Baseline in Patient Reported Disability at 6 Months
Time frame: From enrollment to 6 Months post-operation
Change from Baseline in Patient Reported Disability at 1 Year
Time frame: From enrollment to 1 year post-operation
Change from Baseline in Patient Reported Disability at 2 Years
Time frame: From enrollment to 2 years post-operation
Change from Baseline in SI-Score at 3 Months
Time frame: From enrollment to 3 months post-operation
Change from Baseline in SI-Score at 1 Year
Time frame: From enrollment to 1 year post-operation
Change from Baseline in SI-Score at 2 Years
Time frame: From enrollment to 2 years post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 35148808Zhang W, Sun T, Li Y, Yang M, Zhao Y, Liu J, Li Z. Application of stem cells in the repair of intervertebral disc degeneration. Stem Cell Res Ther. 2022 Feb 11;13(1):70. doi: 10.1186/s13287-022-02745-y.
- Background: PubMed 27585696Elabd C, Centeno CJ, Schultz JR, Lutz G, Ichim T, Silva FJ. Intra-discal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study. J Transl Med. 2016 Sep 1;14(1):253. doi: 10.1186/s12967-016-1015-5.
- Background: PubMed 25794529Mochida J, Sakai D, Nakamura Y, Watanabe T, Yamamoto Y, Kato S. Intervertebral disc repair with activated nucleus pulposus cell transplantation: a three-year, prospective clinical study of its safety. Eur Cell Mater. 2015 Mar 20;29:202-12; discussion 212. doi: 10.22203/ecm.v029a15.
- Background: PubMed 33492116Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Gonzalez-Vallinas M, Sanchez A, Garcia-Sancho J. Treatment of Degenerative Disc Disease With Allogeneic Mesenchymal Stem Cells: Long-term Follow-up Results. Transplantation. 2021 Feb 1;105(2):e25-e27. doi: 10.1097/TP.0000000000003471. No abstract available.
- Background: PubMed 34376494Jerome MA, Lutz C, Lutz GE. Risks of Intradiscal Orthobiologic Injections: A Review of the Literature and Case Series Presentation. Int J Spine Surg. 2021 Apr;15(s1):26-39. doi: 10.14444/8053. Epub 2021 Apr 21.
- Background: PubMed 25187512Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845.
- Background: PubMed 20421856Yoshikawa T, Ueda Y, Miyazaki K, Koizumi M, Takakura Y. Disc regeneration therapy using marrow mesenchymal cell transplantation: a report of two case studies. Spine (Phila Pa 1976). 2010 May 15;35(11):E475-80. doi: 10.1097/BRS.0b013e3181cd2cf4.
- Background: PubMed 21792091Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011 Oct 15;92(7):822-8. doi: 10.1097/TP.0b013e3182298a15.
- Background: PubMed 28086781Comella K, Silbert R, Parlo M. Effects of the intradiscal implantation of stromal vascular fraction plus platelet rich plasma in patients with degenerative disc disease. J Transl Med. 2017 Jan 13;15(1):12. doi: 10.1186/s12967-016-1109-0.
- Cleveland Clinic: Bone Marrow Concentrate (BMC)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Research Assistant contact
Roger Hartl, MD principal investigator
NewYork Presbyterian-Weill Cornell Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Aspirate Concentrate (BMAC) in people with Degenerative Disc Disease and DDD, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Assistant (5163539723, adr4017@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Intervertebral Disc Hydration at 3 Months (time frame: Baseline and 3 Months post-operation). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07386548, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.