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Immunopure
Adsorber for extracorporeal correction of homeostasis
Coming soon!
Apheresis for ulcerative colitis and IBD
What do we know so far?
History of apheresis
Centrifugal apheresis as a treatment for patients with IBD was discovered in the early 1980s in the treatment of patients suffering from Crohn's disease (CD). The initial results were very promising, but they were also associated with increased plasma exchange and high costs. This has led to the use of a less complex procedure for removing leukocytes in patients with Crohn's disease, which has also been described by Bicks et al. in 1985 (3).
In the late 1980s, centrifugation was replaced by adsorption as a method for removing leukocytes. It has also led to an increase in clinical expectations for adsorptive apheresis in terms of therapeutic success in IBD patients.
For this reason, two apheresis systems have been developed in Japan for the treatment of patients with ulcerative colitis and Crohn's disease, which have also been clinically tested.or this reason, two apheresis systems have been developed in Japan for the treatment of patients with ulcerative colitis and Crohn's disease, which have also been clinically tested.For this reason, two apheresis systems have been developed in Japan for the treatment of patients with ulcerative colitis and Crohn's disease, which have also been clinically tested.
Clinical studies have shown that apheresis can be used as a safe and effective alternative or adjunctive treatment to previous therapies (1,2). The procedures are aimed at eliminating inflammatory cells.
New device with selective adsorption.
Recent studies have shown that granulocytes, monocytes and platelets (5, 6) play an important role in the local inflammatory process of the intestinal mucosa. And during the procedures, it has been proven to reduce tissue infiltration by inflammatory cells and prevent the transmigration of pro-inflammatory peripheral blood cells to the site of inflammation.
Immunоpure
■This is a new medical adsorber device using ion exchange resin beads.
■ Length - 185 mm, diameter - 59 mm, total weight - 537 g, total volume - 350 ml, filling volume - 139 ml.
■ Will be used once a week for 5 weeks at a rate of 30 ml/min. using a hemoperfusion pump (LPM-01) with heparin anticoagulant.
■ Has been tested in vitro and on animals to evaluate adsorption characteristics and safety.
■ Was investigated in the first clinical trial in 10 patients with active resistant ulcerative colitis (Table 01.02) with promising results.
Immunopure study in patients with active ulcerative colitis (UC)
►Plan:
open prospective single center pilot study
►Target:
provide data on the safety, tolerability and performance of the Immunopure device in patients with moderate or acute UC.
►Patients:
10 patients with moderate or acute UC who failed to achieve long-term remission while taking steroids and/or immunosuppressants
On the contrary, the number of lymphocytes decreased slightly, while the erythrocytes were not affected by the Immunopure device.
How to perform apheresis with Immunopure?
Treatmentfive courses (once a week for five weeks)
30 ml/min. (within 60 min.)
heparin - anticoagulant
veno-venous procedure
Apheresis for Ulcerative Colitis with Immunopure.
The role of platelets in IBD.
Inflammation of the intestine is associated with cells - granulocytes, changes in the immune system, as well as with the response of non-immune cells, for example, epithelial, mesenchymal, endothelial and platelets. The role of leukocytes in inflammatory bowel disease is well known. Recent publications may provide us with knowledge about the role of platelets in IBD. Crohn's disease and ulcerative colitis are associated with a violation of the number and functional activity of platelets.
In the peripheral circulation, platelet activity is usually increased, and the inflamed intestinal mucosa often contains a mass of aggregated platelets with microthrombi of the mucosa itself. In addition to their traditional role in hemostasis, platelets can also serve as potentially pro-inflammatory cells. This refers to the property of platelets to stimulate the inflammatory process by secreting biologically active substances. In addition to the role of leukocytes in the pathogenesis of IBD, even platelets may be a key factor in the inflammatory process, through the secretion of several mediators. If earlier platelets were considered only as simple participants in the blood coagulation system, then at the moment they have received the status of an important element of the local inflammatory response. Bhatt et al pointed out the need to target this cell type to develop strategies for the treatment of Crohn's disease and ulcerative colitis. Immunopure adsorption device proved to be effective in adsorbing leukocytes as well as platelets.
Immunopure offers new ways to isolate potentially inflammatory cells in IBD: leukocytes and platelets.
The effectiveness of the procedure can be judged by the index of clinical activity (CAI, according to Rakhmilevich (Rachmilewitz)) of all patients who participated in the study (the set of all randomized patients according to the prescribed treatment). According to the definitions of clinical remission and response (remission: CRI ≤ 4, response: CRI ≥ 3 or CFR ≤ 4).
Course of the clinical activity index (CAI) of the population of all randomized patients according to the prescribed treatment.Endoscopic parameters were determined using the endoscopic index (EI according to Rakhmilevich). Endoscopic remission means EI < 4. Thus, 4 patients (44.4%) were in remission, the same patients who had remission of ICA. 1 patient in clinical remission did not undergo endoscopy, 5 patients were not in remission by endoscopic index (55.6%, 3 of them were in clinical remission due to improvements in IQI).
Platelets, monocytes and granulocytes have been described to be effectively reduced during treatment with the Immunopure device.
Immunopure apheresis treatment has been shown to be highly safe in clinical trials. All measured safety parameters remained unchanged during the procedure and in the intervals between procedures.
Clinical efficacy is confirmed by preliminary data - clinical activity index (ICA) and endoscopic index (EI) according to Rakhmilevich. Thus, Immunopure is a new and successful treatment for patients suffering from ulcerative colitis.

Margarita
manager, expert
higher prof. arr.