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C Crisci

Publications and source records attributed to C Crisci.

At least 19 recordsLinked to original sources
PubMed2006

Comparative assessment of the consistency and quality of a highly purified FSH extracted from human urine (urofollitropin) and a recombinant human FSH (follitropin alpha).

The revolutionary development of biotechnology-derived therapeutic proteins has provided the expected improvements in quality, purity and consistency, as demonstrated in recombinant human FSH (rhFSH). However, the development of urine-derived gonadotrophins has not always shown comparable improvements. More recently, highly purified urine-derived FSH (uFSH-HP) products have become widely available. The relative purity, level of urine-derived contaminants, and consistency of one such highly purified human uFSH (uhFSH) (urofollitropin) has been assessed and directly compared with rhFSH (follitropin alpha). It has been demonstrated that the highly purified urofollitropin contains variable levels of urine-derived contaminant proteins and demonstrates a variable level of FSH purity, FSH isoforms, and delivered dose. These variable factors may contribute to the control of ovarian stimulation. The relative purity, variable consistency and the presence of contaminants indicates that the urofollitropin is, at best, a partially purified uFSH that is not able to meet the quality attributes of follitropin alpha (rhFSH).

Blotting, Western↗
PubMed2005

Conversion of a CHO cell culture process from perfusion to fed-batch technology without altering product quality.

During the development of a new drug product, it is a common strategy to develop a first-generation process with the aim to rapidly produce material for pre-clinical and early stage clinical trials. At a later stage of the development, a second-generation process is then introduced with the aim to supply late-stage clinical trials as well as market needs. This work was aimed at comparing the performance of two different CHO cell culture processes (perfusion and fed-batch) used for the production of a therapeutically active recombinant glycoprotein at industrial pilot-scale. The first-generation process was based on the Fibra-Cel packed-bed perfusion technology. It appeared during the development of the candidate drug that high therapeutic doses were required (>100mg per dose), and that future market demand would exceed 100 kg per year. This exceeded by far the production capacity of the first-generation process, and triggered a change of technology from a packed-bed perfusion process with limited scale-up capabilities to a fed-batch process with scale-up potential to typical bioreactor sizes of 15m(3) or more. The productivity per bioreactor unit volume (in product m(-3)year(-1)) of the fed-batch process was about 70% of the level reached with the first-generation perfusion process. However, since the packed-bed perfusion system was limited in scale (0.6m(3) maximum) compared to the volumes reached in suspension cultures (15m(3)), the fed-batch was selected as second-generation process. In fact, the overall process performance (in product year(-1)) was about 18-fold higher for the fed-batch compared to the perfusion mode. Data from perfusion and fed-batch harvests samples indicated that comparable product quality (relative abundance of monomers dimers and aggregates; N-glycan sialylation level; isoforms distribution) was obtained in both processes. To further confirm this observation, purification to homogeneity of the harvest material from both processes, followed by a complementary set of studies (e.g. full physico-chemical characterization, assessment of in vitro and in vivo bioactivity, comparative pharmacokinetics and pharmacodynamics studies in relevant species, etc.) would be required. Finally, this illustrates the need to fix the production process early during the development of a new drug product in order to minimize process conversion efforts and to shorten product development time lines.

Animals↗
PubMed2005

Comparative analytical characterization of two commercial human follicle-stimulating hormones extracted from human urine.

OBJECTIVE: Pharmaceutical preparations of human menopausal gonadotrophin (hMG), urine-derived follicle-stimulating hormone (u-FSH) and highly purified u-FSH (u-FSH-HP) have been available since the early 1960s and the mid 1980s and 1990s, respectively. Another commercial preparation of u-FSH-HP, Folyrmon P, was launched in Japan in 1999. The aim of this study is to assess the purity of Folyrmon P and to compare it with Fertinorm-P, another commercial preparation of u-FSH-HP that has been available since 1993. METHODS: Folyrmon P and Fertinorm-P were assessed for total protein content, biological activity, immunological activity, specific activity, purity and levels of protein contamination. RESULTS: Folyrmon P, which is extracted from the urine of post-menopausal women, has a specific activity of between 4000 and 5000 IU/mg, while Fertinorm-P, which is also manufactured from the urine of post-menopausal women, has a specific activity of at least 10,000 IU/mg. It has been well documented that commercially available hMG and u-FSH preparations can contain a number of urine-derived protein contaminants. This also proves to be the case for Folyrmon P, in which contaminant proteins other than FSH were shown to be present. It was also demonstrated that both preparations, Folyrmon P and Fertinorm-P, contained high levels of oxidized FSH. CONCLUSIONS: The low specific activity and high level of contaminants in Folyrmon P indicate that this u-FSH is not highly purified. Overall, Fertinorm-P, with higher specific activity and lower levels of contaminant proteins, appears to be of higher quality compared with Folyrmon P.

Female↗
PubMed2004

[Intrathoracic omentoplasty in the treatment of pleural cavity secondary to stabilized bronchial fistula].

AIM: The aim of this paper was to verify the effectiveness of omentoplasty, either single or associated to other procedures, in the treatment of permanent fistula of the main bronchi. METHODS: The authors report their experience of 10 intrathoracic omentoplasties for pleural cavity from fistula of the main bronchus. In 2 cases a single omentoplasty was performed, while 8 patients had an associated procedure (4 thoracoplasties, 7 mioplasties and 2 mammoplasties). In 8 cases the vascular pedicle used for the omentum was the right gastroepiploic artery, and the left one in the remaining 2 patients. The omentum was mobilized through an opening in the diaphragm and anchored to the bronchial stump. In the combined plasties it was then covered by chest wall (thoracoplasty), muscles (mioplasty) or mammary gland (mammoplasty); in the single omentoplasty omentum was also sutured to the chest wall. Indication for combined procedures was high bacterial contamination of the pleural cavity; single omentoplasty was performed for small cavities, where other procedures had previously failed. Only in the single omentoplasties a pre-operative selective angiography of the gastroepiploic arteries was performed. RESULTS: Such procedures were resolutive in 9 patients; 1 needed an endoscopic application of fibrin glue. CONCLUSION: Intrathoracic omentoplasty is an effective procedure to solve both pleural cavity and stabilized bronchial fistula, mostly because of plastic and immunologic features of the omentum.

Bronchial Fistula↗
PubMed2004

The ''central'' quadrantectomy. Introducing a new reconstruction technique after excision of the central sub- and periareolar portion of the breast.

A new method is presented for the closure of a central cylindrical breast exeresis, embracing, full thickness, the skin and the gland. For this reconstruction, performed without altering the original shape of the breast, without removing any additional healthy tissue, we used a skin-gland flap rotated from the inferior quadrant to correct the defect.

Breast Neoplasms↗
PubMed2003

Allergenicity of varieties of soybean.

BACKGROUND: Soybean hulls (SHs) cause respiratory allergies. This study investigates the allergenicity of soybean varieties (SVs) by in vivo and in vitro tests. METHODS: Ten SVs were studied: (a) five with a proved clinical relevance (SVs 1, 2, 3, 4, 5), the last four with a 'dull' phenotype; (b) five of undetermined relevance, three of them (SVs 6, 7, 8) with a 'shiny' phenotype, and two (SVs 9 and 10) with a 'dull' phenotype. Extracts from all 10 SVs were used to skin prick test (SPT) 21 subjects sensitized to SHs. Positive and negative sera pools prepared from sera of subjects sensitized or not to SHs, respectively, were utilized to perform in vitro experiments (specific IgE and IgG4 determinations, SDS-PAGE/IgE-Western blot, and IgE-inhibition). RESULTS: In this study, it was found that 52.4, 52.4, 57.1, 71.4, 80.9, 42.9, 57.1, 71.4, 52.4, and 38.1% subjects had a positive SPT with SVs 1-10, respectively (P NS). Specific IgE values to SVs 1-10 obtained with the positive pool are 28.3, 26.4, 29.9, 28.3, 26.8, 4.8, 13.4, 6.7, 24.7, and 17.5% total counts bound, respectively; and specific IgG4 values 0.851, 0.818, 0.721, 1.609, 0.789, 0.617, 0.662, 0.0, 1.127, and 0.934 OD units, respectively; the microgram of protein required to produce 50% inhibition are 2.5, 3.7, 4.5, 2.4, 5, 39.8, 25.2, 25.1, 4.5, and 8.9, respectively. A 7-kDa band is present in all SVs except in those with a 'shiny' phenotype. CONCLUSIONS: The SVs with a 'shiny' phenotype contain less allergens than the other SVs studied, as determined by in vitro tests. However, SPT results with the SVs do not differ. Genetic screens should be devised to select plants with reduced, preferably absent, allergenicity, but with a high nutritional value, and this allergenicity should be studied utilizing in vivo and in vitro tests.

Food Hypersensitivity↗
PubMed2003

Verbal memory impairment in congestive heart failure.

Cognitive dysfunction, mainly memory impairment, characterizes congestive heart failure (CHF). Aim of this study was to verify whether: (1) CHF has differential effects on primary and secondary memory; (2) memory dysfunction can be diagnosed by a screening instrument. In a multicenter study we enrolled 369 patients with stable CHF who underwent a structured assessment of verbal memory mechanisms and selected cognitive functions. Performance on some verbal memory indexes (Recency, Rey's immediate and delayed recall, Learning efficiency) progressively decreased from II to IV New York Heart Association (NYHA) class. Rate of forgetting was uniformly high across NYHA classes II-IV. Verbal memory indexes were highly correlated with most nonverbal scores. The Mini Mental State Examination (MMSE) had poor sensitivity and specificity versus primary or secondary verbal memory dysfunction. Therefore, a deficit of both primary and secondary memory is relatively common in CHF but cannot be accurately recognized by a screening neuropsychological test.

Activities of Daily Living↗
PubMed2003

Systemic sclerosis could mask the presentation of psoriasis in a patient with symptomatic and bilateral sacroiliitis.

Psoriasis is rarely associated with systemic sclerosis (SSc), and sacroiliitis associated to Connective Tissue Diseases is also rather rare. In this report we describe a case of a young woman with SSc who developed symptomatic and bilateral sacroiliitis. The clinical pattern of sacroiliac involvement of this patient resembles that of psoriatic sacroiliitis. HLA typing was compatible with both SSc and psoriasis. Psoriatic sacroiliitis could not be diagnosed, but, on the basis of these observations, the patient described could represent a case of PsA without psoriasis. and psoriatic cutaneous involvement masked by the presence of SSc.

Adult↗
PubMed2001

Internet therapy.

Explore the source record for details and available documents.

Attitude to Death↗
PubMed2001

Small fibers involvement in Friedreich's ataxia.

Although the involvement of large myelinated sensory fibers in Friedreich's ataxia (FA) is well documented, an impairment of unmyelinated fibers has not been described. We demonstrate an involvement of cutaneous unmyelinated sensory and autonomic nerve fibers in FA patients. We performed a morphological and functional study of cutaneous nerve fibers in 14 FA patients and in a population of control subjects. We used immunohistochemical techniques and confocal microscopy applied to punch skin biopsies from thigh, distal leg, and fingertip, and compared the density of epidermal nerve fibers (ENFs) with the results of mechanical pain sensation and thermal and tactile thresholds performed on hand dorsum, thigh, distal leg, and foot dorsum. We observed in our patients a statistically significant loss of ENFs, a reduced innervation of sweat glands, arrector pilorum muscles and arterioles, and an impairment of thermal and tactile thresholds and mechanical pain detection.

Adolescent↗
PubMed2000

Absent innervation of skin and sweat glands in congenital insensitivity to pain with anhidrosis.

OBJECTIVES: A case of a 10-year-old girl with congenital insensitivity to pain with anhidrosis (CIPA) is reported. METHODS AND RESULTS: Parents referred several hyperpyretic episodes without sweating occurring since birth, and insensitivity to pain, noticed when the child was 2 years old. Her body had many bruises and scars, bone fractures and signs of self-mutilation. Neurological examination was normal except for insensitivity to pain. Her IQ was 52. Electrical and tactile sensory nerve conduction velocities were normal. The patient was unable to detect thermal stimuli. Histamine injection evoked a wheal but not a flare; pilocarpine by iontophoresis did not induce sweat. Microneurography showed neural activity from A-beta sensory fibers while nociceptive and skin sympathetic C fiber nerve activity was absent. No small myelinated fibers and very rare unmyelinated fibers were found in the sural nerve. Immunohistochemistry showed a lack of nerve fibers in the epidermis and only few hypotrophic and uninnervated sweat glands in the dermis. CONCLUSIONS: The lack of innervation of the skin (C and A-delta fibers) appears to be the morphological basis of insensitivity to pain and anhidrosis, and is consistent with the loss of unmyelinated and small myelinated fibers in the sural nerve biopsy.

Child↗
PubMed2000

Sensitization to soybean hull allergens in subjects exposed to different levels of soybean dust inhalation in Argentina.

BACKGROUND: Soybean hulls (SHs) have been identified as the source of aeroallergens responsible for soybean asthma outbreaks. However, the prevalence of sensitization to SH allergens in subjects from Argentina, a country where soybeans are produced, is unknown. OBJECTIVE: The purpose of this study was to determine the prevalence of sensitization to SH by in vivo and in vitro tests in subjects with asthma or allergic rhinitis and in control subjects from Argentina who have been exposed to different levels of soybean dust inhalation (SDI). METHODS: Exposure to SDI is defined as follows: (1) direct = occupational, (2) indirect = proximity to soybean fields or grain elevators, and (3) urban = urbanized areas without a known source of SDI. Two groups were studied. Group 1 consisted of 365 subjects with asthma or allergic rhinitis and group 2 (control group) of 50 healthy individuals. Subjects from both groups were classified according to their exposure to SDI. All subjects completed standard questionnaires. Prick skin tests (STs) with an SH extract and with common allergens were performed on all subjects. Specific IgE and IgG4 to SH were measured in sera of 51 of 56 subjects from group 1 who had a positive ST to SH and in all sera from group 2. RESULTS: Fifty-six (15.3%) subjects from group 1 and no subjects from group 2 had a positive ST to SH (wheal SH/wheal histamine >/=0.5). In group 1, positive STs to SH were 38.7%, 20.3%, and 8.2% in subjects with direct, indirect, and urban exposures, respectively (P <.001). Monosensitization to SH is absent in all subjects from group 1. The percent of subjects with positive STs to mites, pollen, and molds was highest in those with a positive ST to SH versus those with a negative ST to SH (P <.01). Asthmatic patients with a positive ST to SH, compared with those exclusively sensitized to mites, had a higher frequency of daily or weekly symptoms (59.4% vs 25.7%, respectively, P <.001) and a higher percent of glucocorticoid dependence (52.8% vs 34%, respectively, P <.01). Percent positive IgE in group 1 and group 2 were 39.2% and 10% (P <.001) and percents positive IgG4 are 27.4% and 12%, respectively (not significant). In subjects from group 1 and group 2 with direct exposure percents positive IgE are 58.3% and 13.3% (P < .001) and percents positive IgG4 were 75% and 20%, respectively (P < .02). IgG4 in group 1 was significantly higher in subjects with direct exposure compared with subjects with indirect or urban exposure. CONCLUSION: This study demonstrated that there was (1) a high prevalence of sensitivity to SH in subjects with asthma or allergic rhinitis from Argentina and (2) an association between sensitivity to SH and severity of asthma and level of exposure to SDI.

Administration, Inhalation↗