RESEARCH

Very quickly, we realized that in order for us to engage in clinical research in PIDD, we needed to create a Patient Registry of PIDD patients under our care.

• We have estimated that 3,400 PIDD patients are currently being cared for by our 17 CIIC clinic members at this time.
• We have established a CIIC Patient Registry on a secure platform and so far populated more than 1,250 patients

The Patient Registry was developed by our expert Immunology members with the idea to incorporate all necessary basic diagnostic and clinical information, including more than 250 field items, to better characterize PIDD and identify potential patients of interest for clinical studies.

The project received IRB approval and currently 17 CIIC clinic members participate in it.

Genetic diagnosis have gained tremendous interest in the last two decades in medicine and in particular in congenital medical conditions. 

PIDD, by definition, are medial conditions due to genetic causes.  Genetic studies have contributed tremendously to our understanding of PIDD and ability develop innovative, life saving therapeutic solutions. 

Even though many cases of PIDD were identified genetically, genetic diagnosis is primarily the domain of research and is poorly covered by insurance companies in clinical routine. Genetic diagnosis of PIDD is necessary to identify the specific genetic cause in order to implement the best existing therapeutic solutions.

The CIIC has teamed up with Seattle Children’s Immunology Institute, under the direction of Dr. Troy Torgerson and Dr. Hans Ochs, to evaluate genetically 500 selected cases of PIDD in trying to establish the validity and importance of genetic testing of PIDD patients. We have secured funding from the Pharmaceutical industry and obtained their generous support (Green Cross Corp., Shire/Takeda, Soleo Health) and obtained IRB approval for the project.

Merited cases identified from the CIIC Patient Registry are the source for patient recruitment. So far more than 40 patients were identified and evaluated. We anticipate completing patient recruitment within the next 18 months.

Our initial research activities as a group were focused on assisting key pharmaceutical companies involved in the various treatment solutions of PIDD. The CIIC acts as an expert advisory group in these particular projects. Such projects included developing guidelines for the standard of care of Immunoglobulin products administered subcutaneously (HyQvia) or intravenously (Octagam).

The CIIC is a cohesive group of experienced Immunologists who have participated in numerous clinical studies in the past, both together as a group, and as individual co-investigators. This experience, along with the CIIC Patient Registry and our Research Management Team, allows us the opportunity to provide interested sponsors in Phase II/III clinical studies with substantial advantages to conduct high-quality, clinical studies in a timely manner while providing significant savings to such sponsors.

We have in place an experienced Research Management Team, with up to date credential documents of all CIIC members/co-investigators and their clinics, and the ability to identify consenting patients of interest from our Patient Registry according to specific sets of exclusion/inclusion criteria.

As a group, we have accomplished together such clinical studies in the past while negotiating as a group, providing all necessary patients to the study project, and helped managed the study in close cooperation with the designated CRO. We were able to accomplish the study projects in a timely manner and provided substantial savings to the Sponsor, compared to the conventional way such studies have been conducted at present.