Case Series on Using Bone Marrow Concentrate for Alar Ligament Injuries

Craniocervical Injuries Clinical Trial

Official title:

A Case Series Evaluating the Use of Bone Marrow Concentrate for the Treatment of Alar, Accessory, and Transverse Ligament Injuries

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03557606
• Other study ID #: RSI2017-CASE01
• Status: Withdrawn
• Start date: August 20, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2019
• Source: Regenexx, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The primary objective of this study is to evaluate the clinical outcomes for patient who are treated with with bone marrow concentrate (BMC) using an anterior approach through the posterior oropharynx for treating alar and transverse ligament injuries as part of their clinical care. The case series will observe pre and post-treatment subject-reported clinical outcomes. Secondary objectives include evaluation of post-treatment complications, adverse events, re-injections, and surgical intervention, change in use of pain medications, and changes on post treatment imaging.

The treatment consists of patients undergoing 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 anesthesia, the injectate is then injected under fluoroscopy into the area in need of treatment using an anterior approach through the posterior oropharynx.

One of the challenges of treating the upper cervical ligaments through injection is that they can't be accessed from the posterior due to obstruction from the cervical spinal cord. The investigator's group has developed an injection technique using an anterior approach through the posterior oropharynx, which allows direct access to the ligaments for injection. The goal of this study is to evaluate the effectiveness of this procedure in CCJ instability patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1) 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:

1. C0-C3 facet injections

2. 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)

1. Upper cervical MRI showing decreased signal in alar, transverse, PAOM, AAOM, or Tectorial membrane

2. 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

3. 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

Exclusion Criteria:

• 1) 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)

2) 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)

7) 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

9) 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

Related Conditions & MeSH terms

• Craniocervical Injuries
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Procedure:
• Alar treatment with BMC using anterior approach
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.

Locations

Country	Name	City	State
United States	Centeno-Schultz Clinic	Broomfield	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Regenexx, LLC

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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, Avon). 1998 Mar;13(2):112-120. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 12 months
Secondary	Neck Disability Index score change from baseline	The within patient mean change from baseline to 6 months in Neck Disability Index scores. Scale of 0-50; 0-4 points (no disability), 5-14 points (mild disability), 15-24 points (moderate disability), 25-34 points (severe disability), 35-50 points (complete disability).	Change from baseline to 6 months
Secondary	Neck Disability Index score change from baseline	The within patient mean change from baseline to 12 months in Neck Disability Index scores.scores. Scale of 0-50; 0-4 points (no disability), 5-14 points (mild disability), 15-24 points (moderate disability), 25-34 points (severe disability), 35-50 points (complete disability).	Change from baseline to 12 months
Secondary	Short Form Health Survey score change from baseline	The within patient mean change from baseline to 6 months in Short Form Health Survey. Two summary scores are derived; the Physical component scale and the Mental component scale, each on a scale of 0-100, where the higher the score, the better the health.	Change from baseline to 6 months
Secondary	Short Form Health Survey score change from baseline	The within patient mean change from baseline to 12 months in Short Form Health Survey. The within patient mean change from baseline to 6 months in Short Form Health Survey. Two summary scores are derived; the Physical component scale and the Mental component scale, each on a scale of 0-100, where the higher the score, the better the health.	Change from baseline to 12 months
Secondary	Numeric Pain scale change from baseline	The within patient mean change from baseline to 6 months in Numeric Pain scale, where 0=no pain and 10=worst possible pain.	Change from baseline to 6 months
Secondary	Numeric Pain scale change from baseline	The within patient mean change from baseline to 12 months in Numeric Pain scale, where 0=no pain and 10=worst possible pain.	Change from baseline to 12 months
Secondary	Single Assessment Numeric Evaluation improvement rating-modified	Mean improvement scores at 6 months, where -100=100% worse from baseline and 100=100% better or improved from baseline.	Mean at 6 months
Secondary	Single Assessment Numeric Evaluation improvement rating-modified	Mean improvement scores at 12 months, where -100=100% worse from baseline and 100=100% better or improved from baseline.	Mean at 12 months
Secondary	Adverse events	Any complication or adverse event	Thru 12 months post-procedure
Secondary	C1-C2 overhang	Post-op DMX studies to quantify any reduction in C1-C2 overhang or ADI.	At least 6 months post-procedure