Use of Bone Marrow Concentrate for Treatment of Alar, Accessory, and Transverse Ligament Injuries

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

March 23, 2018

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2030

Conditions
Craniocervical Injuries
Interventions
BIOLOGICAL

Bone Marrow Concentrate treatment

While under unconscious 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 injectate. Patients will be repositioned in the prone position to then receive upper cervical injections to C0-C3 ligaments and facets.Patients will receive 2 of these treatment procedures 3 months apart.

OTHER

Sham Control

Control subjects will receive a sham procedure of a small skin puncture to the posterior oropharynx guided under fluoroscopy while under anesthesia.Patients will also receive small skin punctures to the back of the neck to mimic ligament and facet injections. Patients will receive 2 of these procedure 3 months apart.

Trial Locations (1)

80021

RECRUITING

Ehren Dodson, Broomfield

All Listed Sponsors
lead

Regenexx, LLC

INDUSTRY