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 difference between treatment groups in the within patient mean change from baseline to 6 months in Headache Impact Test scores.
Change from Baseline to 3 months after 2nd treatment

Secondary Outcomes (10)

Neck Disability Index score change from baseline
Change from baseline to 3 months after 2nd treatment
Neck Disability Index score change from baseline
Change from baseline to 6 months after 2nd treatment
Short Form Health Survey change from baseline
Change from baseline to 3 months after 2nd treatment
Short Form Health Survey change from baseline
Change from baseline to 6 months after 2nd treatment
Numeric Pain Scale change from baseline
Change from baseline to 3 months after 2nd treatment
+5 more secondary outcomes

Study Arms (2)

Bone Marrow Concentrate treatment

EXPERIMENTAL

Bone marrow concentrate subjects 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 nucleated cell layer. Injectate will then be used to treat the ligaments in the CCJ and upper cervical injections to C0-C3 ligaments and facets.

Biological: Bone Marrow Concentrate treatment

Sham Control

SHAM COMPARATOR

Control subjects will also undergo a bone marrow aspiration of 30-60 cc to maintain blinding. Control subjects will receive a sham procedure of a small skin puncture to the posterior oropharynx guided under fluoroscopy while under anesthesia as well as receive sham upper cervical injections to C0-C3 ligaments and facets.

Other: Sham Control

Interventions

Bone Marrow Concentrate treatmentBiological

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.

Bone Marrow Concentrate treatment

Sham ControlOther

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

) 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)

Sponsors & Collaborators

Regenexx, LLC
Industrylead

Study Sites (1)

Ehren Dodson

Broomfield, Colorado, 80021, United States

RECRUITING

Ehren Dodson, PhDCONTACT7202877199 edodson@regenexx.com

Neven Steinmetz, PhDCONTACT3034296448 ext. 141 nsteinmetz@regenexx.com

Christopher Centeno, MDPRINCIPAL INVESTIGATOR

John Schultz, MDSUB INVESTIGATOR

John Pitts, MDSUB INVESTIGATOR

Jason Markle, DO

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
Regenexx, LLC
PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehren R Dodson, PhD

CONTACT

720-287-7199 edodson@regenexx.com

Neven Steinmetz, PhD

CONTACT

nsteinmetz@regenexx.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Masking Details: Participants are blind to treatment condition until 6 months post-procedure. Participants in sham control group can crossover to treatment group at that time.
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

May 7, 2018

Study Start

March 23, 2018

Actual (reported)

You may not qualify if:

\) 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

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Bone Marrow Concentrate treatment

Sham Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

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

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Bone Marrow Concentrate treatment

Sham Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations