Alliance to Cure Cavernous Malformation Clinical Center and Center of Excellence Criteria

Criteria and Application Process

The standard of care at designated sites is expected to meet or exceed the clinical consensus guidelines recognized by the Alliance to Cure’s Scientific Advisory Board. The CCM clinical care consensus guidelines were published in the journal Neurosurgery in May 2017 and are on our website at http://www.alliancetocure.org/CCMGuidelines.

Centers are designated as Clinical Centers or COEs, reflecting the number of clinical disciplines with expertise and the level of involvement in clinical research and professional and patient education. Depending on each institution’s expertise, Clinical Centers and Centers of Excellence (COEs) may treat only adult, pediatric, or both adult and pediatric cases.

Please contact Katie Garbarini at katie@alliancetocure.org for an application.

Clinical Centers

To achieve Clinical Center status, an institution must meet the following criteria:

• The Clinical Center must have a designated medical director who will:
  • Serve as the point of contact for the Alliance to Cure.
  • Ensure continuing compliance with Clinical Center criteria.
  • Participate in the Alliance to Cure Clinical Center Director Committee. The Clinical Center Director Committee meets twice per year to discuss clinical care for cavernous malformation at COEs and Clinical Centers, including best practices, clinical trial updates, challenges in implementing recommendations, and patient access issues. This may include a quarterly email update from each center.

The medical director may choose one or more co-directors to share leadership of the Clinical Center. Ideally, Clinical Center leadership will include a neurosurgeon and a neurologist. The medical director should name a successor should the medical director leave their role. The successor may be a co-director or a physician experienced in caring for patients with cavernous malformation.

• The Clinical Center must have the following core faculty (designated Board-certified specialists who share an understanding of diagnosis and interdisciplinary management of CCM patients), including at least:
  • One cerebrovascular neurosurgeon
  • A neurologist with cerebrovascular specialization
  • An epileptologist
  • A neuroradiologist
  • A nurse coordinator
  • A geneticist, genetic counselor, or neurogenetics fellowship-trained physician

We request that neurology staff be limited to 5 or fewer seeing our patients to ensure expertise. Pediatric facilities may substitute a pediatric neurologist for a neurologist with cerebrovascular specialization.

• Each Clinical Center agrees to meet or exceed local and national standards of medical care.
• Each Clinical Center agrees to utilize CCM-specific consensus recommendations to standardize and optimize the care of patients with CCM.
• The Clinical Center must have a single entry point, allowing all appointments to be scheduled with one call. Administrative staff must have sufficient knowledge to respond to inquiries and promptly coordinate patient care.
• Imaging, neurosurgery, and neurology must have coordinated appointments, preferably lasting no more than two days, reducing the travel burden on out-of-town patients.
• Clinical departments must provide printed patient materials with information about the CCM. The materials may either be generated by the facility or be obtained from the Alliance to Cure.
• The facility can perform 3T MRI.
• The facility must see at least 25 CCM patients annually at the time of application.
• Clinical Centers will provide patient referrals to the Alliance to Cure.
• The Clinical Center is willing to contribute tissue to the Alliance to Cure biobank if requested (if the center is not already utilizing the tissue or collaborating with a different laboratory or institution to use the tissue).
• The Clinical Center is willing to offer each patient an Alliance to Cure survey about their clinic experience. The survey results will be shared with the Alliance to Cure.

Center of Excellence

To achieve Center of Excellence (COE) status, a facility must meet the criteria for a standard Clinical Center plus all the following:

• The COE must have at least two* additional specialty physicians with CCM expertise in any of the following disciplines:
  • Pediatric Neurology
  • Pediatric Neurosurgery
  • Dermatology
  • Neuro-ophthalmology
  • Neuropsychology

*Children’s hospitals may qualify as COEs with one additional specialty.

• The COE maintains an active CCM research program with a history of publications that may include natural history studies, comparative treatment outcomes research, genetics/genomics research, basic science, and/or clinical drug trials.
  • The research must be focused on better understanding or improving care for patients with cavernous malformation.
  • If there are no active clinical research studies due to factors outside of the COE’s control, the Alliance to Cure may request a meeting with the center to discuss the circumstances and long-term plans for CCM research.
• The COE has the capacity to host at least one annual Grand Rounds or professional education event.
• The COE is committed to providing at least one yearly patient engagement activity to the CCM patient community. Example activities include:
  • Creating a lay summary of the COE’s CCM research to share with the Alliance to Cure.
  • Serving as a speaker at an Alliance to Cure monthly webinar or in-person patient conference.
  • Hosting a CCM community event (e.g., a local CCM family day or patient educational conference).
    • The event may be held onsite at the COE, at a community location (e.g., a park or another venue), or hosted virtually.
    • Alliance to Cure will help advertise the event if desired.
  • Developing educational video content about CCM for the COE’s website or Alliance to Cure’s YouTube channel.
  • Contributing to or editing Alliance to Cure developed patient educational materials (brochures, handouts).
• The COE will be a demonstration site for new institutions applying to become Clinical Centers or COEs.
• The COE sees at least 50 CCM patients per year.

Benefits

Clinical Center and COE status is associated with the following benefits:

• Referral of patients by the Alliance to Cure to your institution.
• Alliance to Cure may publicize CCM research studies occurring at designated centers with the permission and approval of the COE or Clinical Center.
• Listing your institution as a Clinical Center or COE on the Alliance to Cure website and in our newsletter.
• The inclusion of your Medical Director (and other faculty members as appropriate) in relevant scientific and clinical communications from the Alliance to Cure.
• The inclusion of your institution in the planning process of various programs through the Alliance to Cure, as appropriate.

Application Process

• Institutions should complete our Clinical Center/COE application. For an application, please contact Katie Garbarini at katie@alliancetocure.org.
• When you submit your application, please include the curriculum vitae for all core faculty.
• Completed applications should be emailed to katie@alliancetocure.org.

Application Review:

• The Alliance to Cure will review the application for completeness.
• Suppose the application indicates minimal criteria have been met for Clinical Center or COE status. In that case, the applicant will be invited to participate in a one-hour video conference with the Alliance to Cure’s Medical Advisory Board.
  • All core faculty should attend this conference if possible.
  • The conference aims to verify the faculty’s understanding of the Clinical Care Consensus Guidelines and ensure proper coordination of care protocols.
  • Written feedback will be provided to the applicant after this conference.
  • The conference will be recorded.
• In some cases, the Alliance to Cure may recommend the applying center’s medical director and nurse coordinator visit a COE for a shadow experience.
• Alliance to Cure will discuss and vote on the prospective Center. If a Center is not approved, deficiencies will be communicated, and the Center may apply again after one year.
• A Center may be granted “provisional” approval contingent on a 6-month review to address any deficiencies. The “provisional” label will be for Alliance to Cure use only. The 6-month review does not require a second video interview.
• Clinical Centers may receive a half-day site visit from the Alliance to Cure executive staff. All designated key personnel should be available for at least a brief visit.

Approved Centers

• Alliance to Cure will work with your marketing department to publicize the Clinical Center or COE designation.
• We encourage centers to set up a photo opportunity and press release.
• Alliance to Cure will encourage patients to attend this opportunity and any luncheon or educational event the center may offer.
• Katie Garbarini, Alliance to Cure Clinical Programs Director, will be the primary point of contact at the Alliance to Cure for each designated center.

Scope of Relationship

• In addition to meeting the minimum standards for Clinical Centers described above, the director or co-director will maintain professional conduct according to their institutional policy.
• If Alliance to Cure becomes aware of any serious professional misconduct under inquiry by the institution, the Clinical Center will temporarily name a colleague to assume his/her role during the inquiry period.
• The Alliance to Cure Clinical Center will be placed on provisional status during the inquiry period.
• The Clinical Center will not solicit Alliance to Cure to raise funds on behalf of their clinic.
• The Clinical Center will maintain open communication with Alliance to Cure by contacting the clinical programs director, Katie Garbarini, whenever issues related to the Alliance to Cure community develop at your clinic.

Maintenance of Clinical Center and COE Status

Annual COE/Clinical Center Information Update

Each COE or Clinical Center will be contacted annually in January by the Alliance to Cure to update the center’s webpage maintained by the Alliance to Cure. Each site will be asked to update the following:

• If there are personnel changes to the providers listed or new faculty additions, CVs should be provided for new faculty members.
• Any research program updates
• Clinic metrics for the previous year (e.g., In the January 2025 update, clinic metrics for January 2024 – December 2024).
• Requested clinic metrics include:
  • Annual number of CCM outpatients: Total number of patients with a CCM diagnosis seen by the clinic
  • Number of CCM-related surgeries per year for CCM patients
    • How many spinal surgeries?
    • How many brainstem surgeries?
  • Annual number of new CCM patients: Total number of new CCM patients seen by the clinic

Renewal of COE/Clinical Center Status

Clinical Centers of Excellence will be re-evaluated every 3 years or if the Medical Director changes. Clinical Centers will be re-evaluated every 2 years or if the Medical Director changes. 

COEs and Clinical Centers will receive a pre-populated application to update for the Alliance to Cure. This application includes a request for clinic metrics, a research update, details about professional and community education events, and the center’s plans for the next 2-3 years.

The Alliance to Cure Medical Advisory Board will review the updated application, and the COE or Clinical Center will receive written feedback. Clinical Centers and Centers of Excellence may be placed on probationary status to give time to address deficiencies.

During re-evaluation, the Alliance to Cure may share summarized Alliance to Cure center-specific survey data and collect and consider community feedback from social media, regional groups, and direct outreach. Community feedback will be summarized and shared directly with the COEs/CCs.

Promotion from Clinical Center to COE

Clinical Centers may apply for designation as COEs. The Alliance to Cure will provide an application for the Clinical Center to complete. The goal of the application is to document that the center now meets expectations for COEs. The Alliance to Cure Medical Advisory Board will review this application and provide written feedback to the prospective COE.

If the Clinical Center does not meet COE expectations, the clinical team may reapply after 6 months, utilizing the Medical Advisory Board’s feedback to improve their application.

Key Differences in COE and Clinical Center Designations

Table 1. Summary table describing key differences between the Clinical Center and COE designations by category. Key differences are in bold.

Updated 3/14/2025