Koo Ap

Apheresis Technologies and Clinical Applications: The 2005 International Apheresis Registry

Abstract:  The developments in apheresis technologies and techniques and their clinical applications worldwide are technologically, sociologically, and economically motivated. In past apheresis surveys the statistics have highlighted both the differences by geographic region in clinical practice and in the types of technologies utilized. While a national view of apheresis is very important, an international view may be more representative overall of this therapeutic modality than national results that are highly dependent on the local economics and the available technologies. These regional differences have provided a basis for scientific and clinical assessment of these apheresis technologies and their clinical outcomes, and have impacted the marketing and business developments of new technologies worldwide. The results of the International Apheresis Registry for 2005 reporting from 22 centers on 5 continents are presented. The survey collected data exclusively via a secure internet website on 1133 patients for a total of 6501 treatments. Unlike our prior registries, information on stem cell infusions was gathered. Information gathered included patient demographics, medical history, treatment diagnoses, treatment specifics (type, methodology, access type, anticoagulants, drugs, and equipment usage), side‐effects, clinical response, and payment provider. As in the prior International Apheresis Registries for 1983, 2000, and 2002 the survey results highlight the regional differences in apheresis usage and treatment methodologies, indicating that an international overview of apheresis may be more representative of the impact of this therapeutic modality.

Clinical trials of a cryoglobulin filter

The authors report the results of clinical trials of a high capacity cryoglobulin filter (Cryofilter) in seven patients with cryoglobulinemia unresponsive to high doses of prednisone or immunosuppressive drugs who required plasmapheresis. The objective of this study was to test the safety and efficacy of the cryofilter in a limited patient population according to the investigational Device Exemption guidelines of the FDA. The cryoglobulins were selectively filtered from plasma at 4 degrees C by a cryofilter characterized by a membrane surface area of 0.135 m2 and an average pore size of 4.3 microns. Safety was evaluated by patients vital signs, complement activation, and clinical score of symptoms in the course of 10 treatments. Efficacy of cryofiltration was evaluated by comparing sieving of the cryoglobulins to that of albumin; immunoglobulins G, A, and M; and fibrinogen. All seven patients completed the series of 10 treatments without notable complement activation or any signs of discomfort. The cryofilter was particularly selective in patients with high cryoglobulin concentrations. Improvement in clinical symptoms was observed in all patients.

Are selective macromolecule removal plasmapheresis systems useful for autoimmune diseases or hyperlipidemia

Although technical limitations exist with existing selective removal systems, very few products are available and no major clinical trials have demonstrated the superiority or equivalence of selective removal systems over plasma exchange. It is generally recognized that selective removal systems are preferable, and that selective macromolecule removal plasmapheresis systems are useful for autoimmune diseases or hyperlipidemia. In the treatment of a disease with a selective removal device, the disease pathogen should be identified and the efficacy of removal demonstrated. In general, for plasmapheresis applications, there is a need to better understand the pathophysiology of the disease states and to identify the pathogenic molecules. With such information, development of the optimal selective removal method will be possible. There is the need for clinical studies to compare selective removal and plasma exchange for specific disease states. Incentives for the development of improved selective removal technologies where cost effectiveness could be demonstrated should be encouraged.