Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain
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ClinicalTrials.gov Identifier: NCT03340818 |
Recruitment Status : Unknown
Verified January 2020 by APM Spine and Sports Physicians.
Recruitment status was: Recruiting
First Posted : November 14, 2017
Last Update Posted : January 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Discogenic Pain | Other: Bone Marrow Concentrate Other: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, double-blind placebo controlled |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Participant and PA providing follow up care and assessing data from ODI, VAS etc will be blinded. Physician performing procedure will not be blinded. |
Primary Purpose: | Treatment |
Official Title: | Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain: A Double-Blind, Placebo Controlled Trial |
Actual Study Start Date : | August 1, 2018 |
Estimated Primary Completion Date : | January 2021 |
Estimated Study Completion Date : | January 2021 |
Arm | Intervention/treatment |
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Experimental: Bone Marrow Concentrate
Patients in this group will receive injection of autologous bone marrow concentrate into the suspected painful intervertebral discs.
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Other: Bone Marrow Concentrate
Bone marrow concentrate is bone marrow harvested from the iliac crest and minimally processed in a centrifuge. It is then injected into the suspected painful disc (s) using fluoroscopic guidance |
Sham Comparator: Placebo Group
Patients in this group will receive an injection of normal saline dorsal to the transverse process. The bone marrow aspiration will be simulated for these patients.
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Other: Placebo
Injection of normal saline dorsal to the transverse process after sham bone marrow aspiration |
- Pain relief treatment vs placebo group 50% [ Time Frame: 6 months ]Pain reduction of at least 50% at 6 months post-procedure using Visual Analog Scale (VAS) as indicators of pain relief. A reduction in the VAS of at least 50% from baseline is considered successful. VAS of 10 is considered "worst pain imaginable" and VAS of 0 is no pain at all.
- Functional improvement vs Placebo group 50% [ Time Frame: 6 months ]Functional improvement of at least 50% at 6 months post-procedure using the Oswestry Disability Index (ODI). A reduction of at least 50% in the Oswestry Disability Index is considered successful. The lower the ODI score, the less impact the pain has on a patients daily functioning.
- Pain relief treatment vs placebo group 50% [ Time Frame: 3 months, 12 months ]Pain reduction of at least 50% will be assessed at 3 and 12 months post-procedure using the Visual Analog Scale (VAS). A reduction of VAS score at 3 and 12 months of at least 50% of baseline will be considered successful. A score of 10 is the "worst pain imaginable" and a score of 0 is no pain at all.
- Pain relief treatment vs placebo 30% [ Time Frame: 3, 6, 12 months ]Pain reduction of at least 30% at 3, 6, 12 months post-procedure using the Visual Analog Scale (VAS). A decrease in score of at least 30% will be considered successful. A score of 10 is "the worst pain imaginable" and a score of 0 is no pain at all.
- Functional improvement treatment vs placebo 50% [ Time Frame: 3 months, 12 months ]Improvement in daily functioning of at least 50% from baseline using the Oswestry Disability Index (ODI). A decrease in score of ODI of at least 50% will be considered successful.
- Functional improvement treatment vs placebo 30% [ Time Frame: 3 months, 12 months ]Improvement in daily functioning of at least 30% from baseline using the Oswestry Disability Index (ODI). A reduction in score by 30% is considered successful
- Medication usage [ Time Frame: 12 months ]Medication log of use of pain medications pre-procedure vs post-procedure will be assessed to determine if less medication has been taken since the procedure when compared with pre-procedure.
- Adjunct therapy [ Time Frame: 12 months ]Log of any adjunctive therapies post procedure

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Chronic low back pain for more than 6 months w/ low back component greater than leg pain.
- Average pain of at lest 40/100 on VAS pre-procedure.
- Inadequate response to at least 6 months of conservative care including medication, physical therapy and/or spinal injection
- Advanced imaging of MRI or CT demonstrating abnormal disc pathology
- Presumed lumbar disc pain based on either positive discogram or patient must have MRi findings of either high intensity zone and/or Type 1 or 2 Modic endplate changes, or exclusion of other sources of pain.
- Having provided informed consent
Exclusion Criteria:
- Active moderate to severe lumbar radiculopathy
- Negative discogram
- Very severe decrease in disc height at planned injection level (disc height of less than 1/3 expected)
- Active infection
- Moderate to severe anemia, thrombocytopenia or leukopenia
- Spinal fracture within the past 6 months
- Severe psychological illness
- Inability to consent to the procedure due to cognitive issues
- Prior surgery at a level considered to be the source of pain
- Lumbar surgery within the past 6 months
- Women who are pregnant or breast feeding
- Prior intradiscal therapeutic injection or procedure
- Severe uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease or any medical condition which would make the subject unsuitable for this study.
- Inflammatory arthritis
- Any cancer within the past 5 years, except basal cell or squamous cell skin cancer
- Intradural disc herniation
- Coagulopathy preventing spinal injection
- Inability to stop anticoagulants other than aspirin due to other medical issues
- Exceeds 30 mg morphine equivalent per day of opioid use.
- A history of alcohol or drug abuse within the past 5 years.
- Use of any investigational drug within the past 30 days.
- Steroid injection in the spine within the past 30 days.
- Discography within the last 21 days
- A known allergy or sensitivity to heparin or citrate (used for processing BMC)
- Pending litigation involving the subject's back pain.
- Active worker's compensation claim
- Central stenosis at a level to be injected with an AP diameter less than or equal to 5 mm
- Severe anaphylactic/anaphylactoid reaction to any of the medications used. (If a patient does have a mild or moderate allergy to any of the medications used in the procedure or prior anaphylactic/anaphylactoid reaction to any food or drug, they will be given prednisone 50 mg PO 13, 7, and 1 hour prior to the procedure and diphenhydramine 50mg PO 1 hour prior to the procedure.)
- In order to mitigate any economic risk, a patient without adequate medical insurance coverage for any subsequent tests or procedures deemed clinically necessary will be excluded. BMC is an autologous blood product with multiple clinical uses. Intradiscal administration should not preclude insurance coverage for any subsequent medical issues that might develop pertaining to the intradiscal injection itself or the BMC

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340818
Contact: Sara A Tyszko, PA-C | 757-490-4802 | styszko@jordan-younginstitute.com | |
Contact: David S Levi, MD | 757-490-4802 |
United States, Virginia | |
Jordan Young Institute | Recruiting |
Virginia Beach, Virginia, United States, 23462 | |
Contact: Sara A Tyszko, PA-C 757-490-4802 styszko@jordan-younginstitute.com | |
Contact: David S Levi, MD 757-490-4802 | |
Principal Investigator: David S Levi, MD | |
Sub-Investigator: Scott I Horn, DO | |
Sub-Investigator: Josh Levin, MD | |
Sub-Investigator: Sara A Tyszko, PA-C |
Principal Investigator: | David S Levi, MD | Jordan Young Institute | |
Study Chair: | Scott I Horn, DO | Jordan Young Institute | |
Study Chair: | Josh Levin, MD | Stanford University | |
Study Chair: | Sara A Tyszko, PA-C | Jordan Young Institute |
Documents provided by APM Spine and Sports Physicians:
Responsible Party: | APM Spine and Sports Physicians |
ClinicalTrials.gov Identifier: | NCT03340818 |
Other Study ID Numbers: |
BMC-1788 |
First Posted: | November 14, 2017 Key Record Dates |
Last Update Posted: | January 18, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Low back pain, bone marrow concentrate, disc degeneration |
Back Pain Low Back Pain Pain Neurologic Manifestations |