We have an open study on the new PICL procedure to treat craniocervical instability. Given that the procedure is delivered at no charge and we have seen great interest in this type of treatment, I thought it was important to get this out there. Let’s dig in.
What is CCI and the PICL Procedure?
CCI stands for Craniocervical Instability. This diagnosis is made when there has been trauma to the head/neck damaging ligaments or because of loose ligaments from birth. These are the ligaments that hold the head on, so instability in the upper neck can cause a bevy of common symptoms including headaches, dizziness/imbalance, visual changes, rapid heart rate, and many more. Treatment to date has either been bracing, physical therapy, or surgical fusion. This research is on a new non-surgical procedure called PICL.
PICL stands for Percutaneous Implantation of the Craniocervical Ligaments. In this procedure, bone marrow concentrate is taken from the back of the hip area (PSIS), processed in a cleanroom lab to remove the stem cell fraction, and then reinjected using x-ray guidance and endoscopy into the damaged ligaments. To learn more about this procedure, see my video below:
What Does the Study Look Like?
The study is a randomized controlled trial with a single-blinded placebo. That means that once a patient is accepted into the study, they will be randomized to get either the actual procedure or no procedure (placebo). They will be “unblinded” at 6 months and if they were in the placebo group, they have the option to cross over into the treatment group.
The patient will get a bone marrow aspirate performed no matter which group they’re in. That means that if they’re in the treatment group that bone marrow concentrate will be used for the treatment. If they’re not in that group and are in the placebo group, then they will be put to sleep for the procedure and only the back of the throat will be poked without any injection into the ligaments. After that procedure, the patient is not permitted to have contact with the treating physician who knows which of the two procedures they received.
At the 6-month mark, the patient will be “unblinded”. That means they will be told if they were in the treatment or placebo group. If in the later, they can opt to get the treatment. If in the former and if they showed progress from the first procedure, they can opt for a second. Both groups can get up to two treatments.
Who is a Candidate?
While there are many things on the inclusion and exclusion lists, the main things you should know about include:
- A traumatic injury that caused the problem
- Certain imaging findings that show that the upper neck is unstable
- Prior injections of the upper neck joints (C0-C3) that didn’t work to get rid of the symptoms
- Ehlers-Danlos hypermobility syndrome (hEDS)
- A prior fusion surgery
- A prior neck or skull base surgery
What Are the Costs?
The cost of the PICL procedure is no charge as described. The cost of any other care outside of that would generally be borne by the patient. So for example, the needed facet injections in the upper neck are borne by the patient. If there is a complication, while the doctors in the study would donate their office time to get the patient the right care, the cost of that care that occurs outside of the clinic is again borne by the patient.
What Are the Risks?
To date, approximately 180 of these procedures have been performed without serious adverse events that have caused permanent harm. However, the main risks still include:
- Infection – If this were to occur, this could turn into serious life-threatening meningitis.
- Nerve damage – The patient could have nerves in the injection area that are not typical of the nerve pathway for most patients and these could be injured.
- Spinal Cord Injury -Even though x-ray guidance is used to make sure the needle is in the right place, it’s theoretically possible that the needle or excessive bleeding could inadvertently damage the spinal cord. This could cause temporary or permanent paralysis.
- Worsening of the problem – Any procedure has the potential to make the main problem worse.
Where Is this Study?
This study is only performed at Regenexx HQ in Colorado. It requires many special components and skills that are only present at that site. It also requires patient-funded travel if you are not local.
Who Do I Contact To See If I Qualify?
Ehren Dodson, Pd.D. is our director of clinical research. Her e-mail is [email protected]
The upshot? This study is to gather research on this new technique to provide better tools to help patients with CCI. If you think you might qualify and don’t mind being randomized to a control group for 6 months, please contact us so we can review your case. Participating in this research might not only help you but potentially many others!