The properties of a reference bacterial endotoxin prepared from Escherichia coli and its phthalylated derivative were studied in normal human volunteers infected intravenously with the compounds. The minimal pyrogenic dose of the reference endotoxin is about 0.1-0.5 ng/kg. The increase in white blood cell count, absolute granulocyte count, absolute immature granulocyte count, and concentrations of serum amyloid A, cortisol, and growth hormone was directly related to the concentration of reference endotoxin administered. Phthalylated reference endotoxin up to 1,000 ng/kg (at least 500 ng of the patent compound/kg) was administered to normal human volunteers without significant changes in temperature, white blood cell count, absolute granulocyte count, and concentrations of serum amyloid A, cortisol, and growth hormone. Thus, this study defines biologic properties of the new reference bacterial endotoxin in humans and demonstrates effective detoxification by phthalylation of the present compound.
Background: Extracorporeal photochemotherapy (EP) is a new immune-modulating therapy which combines cytapheresis and extracorporeal irradiation of leukocytes by UVA. Recently, patients with systemic sclerosis (SS) have been treated by this method, but the efficacy of EP is still controversial. Objective: Our purpose was to evaluate the efficacy and safety of EP in SS and in severe morphea. Methods: In an open study, 7 patients with SS and 2 patients with severe morphea were treated by EP and were evaluated after 6 months of treatment. No other treatments were allowed during this period. Results: Except one vasovagal reaction, EP was well tolerated in all patients. The surface of the cutaneous sclerosis was unchanged in 3 of the 7 patients with SS, whereas it was aggravated in the remaining 4 patients. There was no improvement of the visceral involvement of SS in these patients. Although the duration of SS was less than 4 years in 6 out of 7 patients, we did not observe any significant benefit from EP in SS patients. One patient with generalized morphea had stopped EP after 3 months because of loss of vascular access and could not be evaluated. In the last patient with linear morphea of the upper limbs, a reduction in the number of morphea plaques was observed, and the remaining lesions were less visible after 16 months of EP. Conclusions: The present results do not corroborate those previously published with regard to the efficiency of EP in SS of recent onset. The efficacy of ECP in morphea needs further confirmation.
Human monocytes (Mo) and monocyte-derived macroresponse. To overcome this limitation we have developed phages (MdM) are major effectors in host defense systems a gene transfer protocol with IFN-␥ cDNA and polyethyleniagainst cancer. Their antitumoral activity is dependent mine so as to obtain an efficient, long-lasting autocrine upon two processes: recruitment and activation. One of the cytocidal activation in transfected human Mo/MdM. We most powerful activators for these cells is recombinant show, by clonogenic assays, that efficient transfection and human IFN-␥ (rhIFN-␥). However, when the potential of tumoricidal activity can be obtained by this method in activated rhIFN-␥ was evaluated in clinical trials by ex vivo human monocyte populations. Although the proposed adoptive cellular immunotherapy protocols, the major probmodel must be improved before clinical use, IFN-␥ produclem was the short duration of ex vivo activation by rhIFN-␥.ing monocytes have potential for adoptive immunotherapy. Thus repeated injections were required to obtain a clinical
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