Craniocervical InjuriesNCT03557606
Case Series on Using Bone Marrow Concentrate for Alar Ligament Injuries
An observational study of Craniocervical Injuries, run by Regenexx, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Craniocervical Injuries
- What is being tested?
- Alar treatment with BMC using anterior approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seeking treatment at an orthopedic pain management and regenerative medicine clinic.
Who may be able to join
- 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:
- 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)
- <!-- -->
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Case Series Evaluating the Use of Bone Marrow Concentrate for the Treatment of Alar, Accessory, and Transverse Ligament Injuries
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.
Read the detailed 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.
- Conditions
- Craniocervical Injuries
- Being tested
- Alar treatment with BMC using anterior approach
- Keywords
- CCJ, Bone Marrow Concentrate, Stem Cell Therapy, Alar Ligament, Transverse Ligament
- Medical subject headings
- Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alar treatment with BMC using anterior approachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Alar treatment with BMC | Patients with CCJ instability that receive Alar treatment with BMC using anterior approach. Receives: Procedure: Alar treatment with BMC using anterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ).
Measured: Change from Baseline to 6 months
Secondary outcomes (11)
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 ).
Measured: Change from baseline to 12 months
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).
Measured: Change from baseline to 6 months
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).
Measured: Change from baseline to 12 months
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.
Measured: Change from baseline to 6 months
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.
Measured: Change from baseline to 12 months
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.
Measured: Change from baseline to 6 months
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.
Measured: Change from baseline to 12 months
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.
Measured: Mean at 6 months
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.
Measured: Mean at 12 months
Adverse events
Any complication or adverse event
Measured: Thru 12 months post-procedure
C1-C2 overhang
Post-op DMX studies to quantify any reduction in C1-C2 overhang or ADI.
Measured: At least 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start20 Aug 2018 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Collecting data as part of a Patient Registry; redundant study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Craniocervical InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Centeno, MD, Principal investigator, Centeno-Schultz Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557606
- Sponsor's protocol ID
- RSI2017-CASE01
- Status last verified
- Mar 2019
- First submitted
- 9 May 2018
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16850045Panjabi 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.
PubMed 11415778Rajwanshi 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.
PubMed 27489015Centeno 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.
PubMed 26261424
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series Evaluating the Use of Bone Marrow Concentrate for the Treatment of Alar, Accessory, and Transverse Ligament Injuries
- ClinicalTrials.gov ID
- NCT03557606
- Acronym / sponsor ID
- RSI2017-CASE01
- Conditions
- Craniocervical Injuries
- Keywords
- CCJ, Bone Marrow Concentrate, Stem Cell Therapy, Alar Ligament, Transverse Ligament
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Collecting data as part of a Patient Registry; redundant study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alar treatment with BMC | – | Procedure: Alar treatment with BMC using anterior approachPatients with CCJ instability that receive Alar treatment with BMC using anterior approach. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking treatment at an orthopedic pain management and regenerative medicine clinic.
Key inclusion criteria (7 listed)
- 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:
- <!-- -->
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alar treatment with BMC using anterior approachPatients 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. | Procedure or surgery | Alar treatment with BMC |
Primary outcome
Headache Impact Test score change from baseline
Time frame: Change from Baseline to 6 months
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 ).
11 secondary outcomes
Headache Impact Test score change from baseline
Time frame: Change from baseline to 12 months
Neck Disability Index score change from baseline
Time frame: Change from baseline to 6 months
Neck Disability Index score change from baseline
Time frame: Change from baseline to 12 months
Short Form Health Survey score change from baseline
Time frame: Change from baseline to 6 months
Short Form Health Survey score change from baseline
Time frame: Change from baseline to 12 months
Numeric Pain scale change from baseline
Time frame: Change from baseline to 6 months
Numeric Pain scale change from baseline
Time frame: Change from baseline to 12 months
Single Assessment Numeric Evaluation improvement rating-modified
Time frame: Mean at 6 months
Single Assessment Numeric Evaluation improvement rating-modified
Time frame: Mean at 12 months
Adverse events
Time frame: Thru 12 months post-procedure
C1-C2 overhang
Time frame: At least 6 months post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Background: PubMed 16850045Centeno 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.
- Background: PubMed 11415778Panjabi 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.
- Background: PubMed 27489015Rajwanshi 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.
- Background: PubMed 26261424Centeno 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.
- Individual participant dataSharing planned: No
Related trials for Craniocervical Injuries
Enrolling by invitationObservational study
Posterior Cervical Fixation Study
Degenerative Disc Disease, Craniocervical Injuries
Recruiting
Use of Bone Marrow Concentrate for Treatment of Alar, Accessory, and Transverse Ligament Injuries
Craniocervical Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Centeno, MD principal investigator
Centeno-Schultz Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniocervical Injuries, run by Regenexx, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Test score change from baseline (time frame: Change from Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03557606, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019; AzTrials last refreshed its copy on 30 Oct 2026.