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Stem Cell Therapy
Bone Marrow Concentrate for Craniocervical Injury
N/A
Recruiting
Led By Christopher Centeno, MD
Research Sponsored by Regenexx, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Patient must be able to care for themselves without assistance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up thru 6 month post procedure after 2nd treatment
Awards & highlights
Study Summary
This trial will study whether using bone marrow concentrate to treat alar and transverse ligament injuries through the posterior oropharynx is an effective treatment for patients with CCJ instability.
Who is the study for?
This trial is for men and women aged 18-65 who have had a traumatic injury to the head or neck within the last 10 years, leading to instability at where the skull meets the spine. They should be able to care for themselves, have moderate disability from their condition, and not responded well to other treatments. Candidates are those wanting to avoid surgery but show signs of upper cervical injury.Check my eligibility
What is being tested?
The study tests bone marrow concentrate treatment's effectiveness against a sham control in treating ligament injuries at the craniocervical junction (where the skull meets the spine). The treatment involves an anterior approach through the back of the mouth area.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include pain at injection site, infection risk due to injections, possible allergic reactions to materials used during procedure, and general discomfort associated with medical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have headaches with dizziness, vertigo, imbalance, or vision problems since an event.
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I can take care of myself without help.
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I am a candidate for neck surgery to join two or more bones in my upper spine.
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I am between 18 and 65 years old and my bones have stopped growing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ thru 6 month post procedure after 2nd treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~thru 6 month post procedure after 2nd treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Impacted tooth
Secondary outcome measures
Adverse events
C1-C2 overhang
Neck Disability Index score change from baseline
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bone Marrow Concentrate treatmentExperimental Treatment1 Intervention
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.
Group II: Sham ControlPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Regenexx, LLCLead Sponsor
14 Previous Clinical Trials
50,765 Total Patients Enrolled
Christopher Centeno, MDPrincipal InvestigatorRegenexx, LLC
12 Previous Clinical Trials
50,317 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition hasn't improved with standard treatments.I have muscle or tendon problems from taking statins or quinolones.I have a bleeding disorder.I rely on a strong painkiller daily.I have headaches with dizziness, vertigo, imbalance, or vision problems since an event.I can take care of myself without help.I haven't had a steroid injection in the past 6 months.I am unable to undergo surgery or anesthesia due to my physical condition.I am a candidate for neck surgery to join two or more bones in my upper spine.I have pain or symptoms like numbness in my lower neck area.I can move around on my own and can attend all follow-up appointments.I strongly prefer not to have surgery.I have had surgery or spinal fusion in my neck, mid-back, or lower back.I have diabetes, an eating disorder, or my BMI is over 40.My MRI shows I have unusual neck/spine anatomy that could make surgery risky.I have had radiofrequency ablation on my neck spine in the last 2 years.I have an inflammatory or autoimmune condition like rheumatoid arthritis.I am between 18 and 65 years old and my bones have stopped growing.I am currently on blood thinners or drugs that suppress my immune system.I haven't had prolotherapy or platelet injections in my neck in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Control
- Group 2: Bone Marrow Concentrate treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must a person meet to partake in this investigation?
"This study is recruiting 80 adult individuals, aged 18 to 65 years old, with current wounds. Desired research subjects must fulfil the following criteria: a) Provide voluntary signature on an IRB authorised Informed Consent; b) Have sustained trauma-induced symptoms in the last 10 years that cause them to seek medical attention c) Predominantly suffer from headaches, vertigo, imbalance or visual disturbances d) Able to self care without aid e) Score 30% or higher on NDI (Neck Disability Index), f ) Possess DMX lateral overhang of C1 and C2 exceeding 3mm and/or Grabb-O"
Answered by AI
What is the maximum capacity for participants in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical trial was published on March 23rd 2018 and recently re-edited on January 25th 2022. To complete the study, 80 participants are being sought at a single center of care."
Answered by AI
Is there an open enrollment period for this research endeavor?
"Information from clinicaltrials.gov denotes that this research trial is in the midst of recruiting participants, with its first post dating back to March 23rd 2018 and its most recent update on January 25th 2022."
Answered by AI
Are octogenarians considered suitable candidates for this experiment?
"Participants must be within the 18-65 age range in order to join this clinical trial. Alternatively, there are separate trials for people under 18 and those over 65 with 123 and 595 studies respectively."
Answered by AI
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