Using bone marrow concentrate to treat ligament injuries in the neck
A Single-Blinded, Randomized Controlled Trial Evaluating the Use of Bone Marrow Concentrate for the Treatment of Alar, Accessory, and Transverse Ligament Injuries
This study is testing whether using bone marrow concentrate can help people with neck ligament injuries feel better and recover from craniocervical junction instability.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Regenexx, LLC Industry-sponsored |
| Locations | 1 site (Broomfield, Colorado) |
| Trial ID | NCT03517761 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of bone marrow concentrate (BMC) for treating alar and transverse ligament injuries in patients with craniocervical junction (CCJ) instability. It is a single-center, prospective, single-blinded, randomized, controlled study where participants will receive either BMC treatments or sham procedures. Patients will undergo bone marrow aspiration and subsequent injections into the affected area using an anterior approach through the posterior oropharynx, with fluoroscopic guidance. The study aims to assess both the safety and effectiveness of this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates are skeletally mature individuals aged 18 to 65 with specific upper cervical symptoms following a traumatic injury.
Not a fit: Patients who have not experienced a recent traumatic injury or those who have not responded to conservative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients suffering from CCJ instability.
How similar studies have performed: While the use of bone marrow concentrate in orthopedic applications has shown promise, this specific approach for CCJ instability is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -1) Voluntary signature of the IRB approved Informed Consent, 2) Skeletally mature Male or Female ages 18 to 65 3) Must have a specific inciting injury event that occurred less than 10 years ago where the patient experienced trauma that caused the problem-meaning from that day on, they had the symptoms for which they are now seeking treatment 4) Upper cervical symptoms predominate: Patient must have a headache since the event and must have one of the following: dizziness, vertigo, imbalance, or visual disturbances 5) Patient must be able to care for themselves without assistance 6) NDI percentage score (raw NDI score times 2) at least 30 (moderate disability) 7) Imaging: Must have DMX lateral overhang of C1 on C2 in lateral bending open mouth view of at least 3mm or grabb-oakes of \>9mm on cervical flexion MRI-change in signal on static imaging does not qualify the patient 8) Has not responded long-term to conservative care 9) Upper cervical fusion candidate 10) Exam is c/w upper cervical injury (i.e. tenderness along upper cervical facet joints and/or musculature/skull base, proprioceptive difficulties) 11\) Is independent, ambulatory, and can comply with all post-operative evaluations and visits 12) Patient states strong desire to avoid surgery Exclusion criteria: 13\) Known or diagnosed EDS based on Beighton criteria: https://www.physio-pedia.com/Beighton\_score 14) Lower or mid-cervical symptomatic disease (tenderness in mid to lower cervical facets, radiculopathy, radiating symptoms into shoulder blade, epicondylitis, numbness and tingling in hands) 15) Prior spinal fusion or surgery at any segment in cervical, thoracic, or lumbar spine 16) NDI % score \> than 56 (severe disability), unless at the discretion of the independent physician review 17) Prior or current history of a metabolic disorder like diabetes, anorexia, other eating disorder, BMI\>40 18) Unable to tolerate injections due to central sensitization (i.e. significant intolerance to manual therapy such as massage, activity such as physical therapy, or an exaggerated pain response to prior injection therapy) 19) Prior epidural or other milligram dose steroid injection in any area within the past 6 months 20) Prior prolotherapy or platelet-based injections to the cervical spine within the last 3 months 21) Prior radiofrequency ablation to the cervical spine within the last 2 years 22) Physical infirmity that is incompatible with the procedure and/or anesthesia required for same 23) Unable to tolerate the injection position 24) Abnormal anatomy seen on MRI imaging that would make the procedure higher risk (e.g. congenital atlanto-axial fusion, atlas assimilation, upper cervical fracture or surgical fusion) 25) Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudo gout) 26) Quinolone or Statin induced myopathy/tendinopathy 27) Condition represents a worker's compensation case 28) Currently involved in a health-related litigation procedure 29) Is pregnant 30) Bleeding disorders 31) Currently taking anticoagulant or immunosuppressive medication 32) Allergy or intolerance to study medication 33) Use of and significant physical dependence on a chronic opioid (\>20 mg oxycodone equivalent per day) 34) Documented history of drug abuse within six months of treatment 35) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
Where this trial is running
Broomfield, Colorado
- Ehren Dodson — Broomfield, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Centeno, MD — Regenexx, LLC
- Study coordinator: Ehren R Dodson, PhD
- Email: edodson@regenexx.com
- Phone: 720-287-7199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.