Case Series on Using Bone Marrow Concentrate for Alar Ligament Injuries

NCT03557606 | Withdrawn

• 1 other identifier: RSI2017-CASE01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective case series of 200 patients who have been treated with Bone Marrow Concentrate using anterior approach through posterior oropharynx for treating alar, accessory, and transverse injuries for patients with craniocervical junction instability.

Conditions

Craniocervical Injuries

Keywords

CCJ; Bone Marrow Concentrate; Stem Cell Therapy; Alar Ligament; Transverse Ligament

Outcome Measures

Primary Outcomes (1)

• Headache Impact Test score change from baseline

  The within patient mean change from baseline to 6 months in Headache Impact Test scores. Scale of 36-78; HIT-6 scores 36-49 (little to no impact), HIT-6 scores 50-55 (moderate impact), HIT-6 scores 56-59 (substantial impact), HIT-6 scores 60-78 (severe impact ).

  Change from Baseline to 6 months

Secondary Outcomes (11)

• Headache Impact Test score change from baseline

  Change from baseline to 12 months

• Neck Disability Index score change from baseline

  Change from baseline to 6 months

• Neck Disability Index score change from baseline

  Change from baseline to 12 months

• Short Form Health Survey score change from baseline

  Change from baseline to 6 months

• Short Form Health Survey score change from baseline

  Change from baseline to 12 months

Study Arms (1)

Alar treatment with BMC

Patients with CCJ instability that receive Alar treatment with BMC using anterior approach.

Procedure: Alar treatment with BMC using anterior approach

Interventions

Alar treatment with BMC using anterior approach PROCEDURE

Patients with CCJ instability will undergo a bone marrow aspiration of approximately 30-60 cc. Platelet rich plasma (PRP) and platelet lysate (PL) will be derived from the bone marrow aspirate and later mixed with the bone marrow cell layer. While under TIVA anesthesia, the injectate is then injected under fluoroscopy into the area in need of treatment using an anterior approach through the posterior oropharynx with direct visualization of the injection site via endoscopy. The alar, transverse, and accessory ligaments are the target areas to be treated with the bone marrow concentrate.

Alar treatment with BMC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients seeking treatment at an orthopedic pain management and regenerative medicine clinic.

You may qualify if:

• \) Voluntary signature of the IRB approved Informed Consent, 2) Skeletally mature Male or Female ages 18 to 65 3) Disabling symptoms of headache, dizziness, neck pain, or other neuro-musculoskeletal symptoms, that based on physical exam or diagnostic blocks is attributable to the upper cervical spine for \>12 months 4) Symptoms exacerbated by activity and relieved by rest 5) Failed all conservative care 6) Hasn't responded long-term to:
• C0-C3 facet injections
• Upper cervical prolotherapy or PRP into the posterior stabilizing ligaments (nuchal, supraspinous, interspinous ligaments) 7) Considered a likely cervical fusion candidate 8) Imaging (one of the three)
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• Upper cervical MRI showing decreased signal in alar, transverse, PAOM, AAOM, or Tectorial membrane
• DMX showing 2 mm or greater lateral overhang of C1 on C2 in lateral bending open mouth view or a V shaped ADI in flexion of increased ADI in flexion
• Upper cervical rotatory CT that shows excessive C0-C1 rotation 9) Exam is c/w upper cervical injury (i.e. tenderness along upper cervical facet joints and/or musculature/skull base, good anesthetic block response (\>50% pain relief) to C0-C3 intra-articular facet injections, proprioceptive difficulties) 10) Is independent, ambulatory, and can comply with all post-operative evaluations and visits 11) Patient states strong desire to avoid surgery

You may not qualify if:

• \) 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)
• \) Previous neck surgery that has caused chronic neck pain or radiculopathy 3) Prior epidural or other milligram dose steroid injection in any area or other neck injection therapy within the past 6 months 4) Physical infirmity that is incompatible with the procedure and/or anesthesia required for same 5) Unable to tolerate the injection position 6) 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)
• \) Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudo gout) 8) Quinolone or Statin induced myopathy/tendinopathy
• \) Condition represents a worker's compensation case 10) Currently involved in a health-related litigation procedure 11) Is pregnant 12) Bleeding disorders 13) Currently taking anticoagulant or immunosuppressive medication 14) Allergy or intolerance to study medication 15) Use of and significant physical dependence on a chronic opioid (\>20 mg oxycodone equivalent per day) 16) Documented history of drug abuse within six months of treatment 17) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (1)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Related Publications (4)

• Centeno CJ, Elliott J, Elkins WL, Freeman M. Fluoroscopically guided cervical prolotherapy for instability with blinded pre and post radiographic reading. Pain Physician. 2005 Jan;8(1):67-72.

  PMID: 16850045 BACKGROUND

• Panjabi MM, Crisco JJ 3rd, Lydon C, Dvorak J. The mechanical properties of human alar and transverse ligaments at slow and fast extension rates. Clin Biomech (Bristol). 1998 Mar;13(2):112-120. doi: 10.1016/s0268-0033(97)00053-3.

  PMID: 11415778 BACKGROUND

• Rajwanshi A, Rohilla M, Singh P. Trans-oral fine needle aspiration cytology in cervical (C1 and C2) vertebral lesions: a novel diagnostic approach. Cytopathology. 2017 Feb;28(1):31-34. doi: 10.1111/cyt.12361. Epub 2016 Aug 3.

  PMID: 27489015 BACKGROUND

• Centeno CJ, Pitts J, Al-Sayegh H, Freeman MD. Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. J Pain Res. 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. eCollection 2015.

  PMID: 26261424 BACKGROUND

MeSH Terms

Conditions

Trauma, Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries

Study Officials

• Christopher Centeno, MD

  Centeno-Schultz Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 15, 2018
• Study Start: August 20, 2018
• Primary Completion: May 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)