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Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain

CompletedNot applicableNCT03340818
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain.

Study details

Official title
Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain: A Double-Blind, Placebo Controlled Trial
Conditions
  • Discogenic Pain
Interventions
Sponsor
APM Spine and Sports Physicians
Start date
2018-08-01
Primary completion
2024-08-07
Sex
All
Age range
from 18 Years to 55 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 g…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03340818