Trials Sponsors Conditions Drugs Pricing

Conditions

Craniocervical Injuries

Keywords

CCJBone Marrow ConcentrateStem Cell TherapyAlar LigamentTransverse 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
+6 more secondary outcomes

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 approachProcedure

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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:

Sponsors & Collaborators

Regenexx, LLC
Industrylead

Study Sites (1)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

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: 16850045BACKGROUND
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: 11415778BACKGROUND

MeSH Terms

Conditions

Trauma, Nervous System

Condition Hierarchy (Ancestors)

Nervous System DiseasesWounds and Injuries

Study Officials

Christopher Centeno, MD
Centeno-Schultz Clinic
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

Case Series on Using Bone Marrow Concentrate for Alar Ligament Injuries

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

Alar treatment with BMC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

Alar treatment with BMC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations