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California Stem Cell Agency Blogs on Geron Clinical Trial

Posted: November 19, 2012 at 8:55 pm


The California stem cell agency
published an article online last week concerning the hESC clinical
trial that Geron abandoned last year, dealing mainly with one of the
participants in the program.

The piece was studiously non-committal
about whether the $3 billion research program is likely to fund the
trial once again, should BioTime, Inc., of Alameda, Ca., be
successful in acquiring the assets of once was the first hESC
clinical trial in the United States. The agency loaned Geron $25
million a few months before the company cancelled the trial.
Amy Adams, CIRM's communications
manager, simply wrote,

“They (BioTime) would need to apply
for a loan if they want CIRM to financially support the continued
trial.”

The latest round of funding that
BioTime could apply for has a deadline of Dec. 18 for letters of
intent. In addition to a loan, a grant is also a possibility.
Adams focused on Katie Sharify, who was
enrolled in the clinical trial shortly before Geron said it was
dropping the effort for financial reasons. Adams interviewed Sharify
before an audience of scientists.
Adams wrote,

“Katie told me that it would be
impossible not to hope that a trial would help her, but that by the
time she made the decision to participate she knew she was doing it
to further science, not necessarily to further her own recovery. She
told the audience, 'I was part of something that was bigger than me,
and bigger than all of you.'”

Stem cell scientist Paul Knoepfler of
UC Davis also wrote about the BioTime-Geron deal last week. Noting
that Geron's decision a year ago left many “upset to put it
mildly,” Knoepfler said the “idea of BioTime buying the Geron
stem cell program is a great one that provides new hope on many
levels.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VlS7kYH6oy4/california-stem-cell-agency-blogs-on.html

Recommendation and review posted by G. Smith

Diagnostic delay for endometriosis in Austria and Germany: causes and possible consequences

Posted: November 19, 2012 at 3:18 pm

STUDY QUESTION

What is the length of the diagnostic delay for endometriosis in Austria and Germany, and what are the reasons for the delay?

SUMMARY ANSWER

The diagnostic delay for endometriosis in Austria and Germany is surprisingly long, due to both medical and psychosocial reasons.

WHAT IS KNOWN ALREADY

Diagnostic delay of endometriosis is a problematic phenomenon which has been evaluated in several European countries and in the USA, but has not been reported for Germany and Austria.

STUDY DESIGN, SIZE, DURATION

A cross-sectional, questionnaire-based multicentre study was conducted in tertiary referral centers in Austria and Germany. From September 2010 to February 2012, 171 patients with histologically confirmed endometriosis were included.

PARTICIPANTS, SETTING, METHODS

Patients with a previous history of surgically proven endometriosis, internal diseases such as rheumatic disorders, pain symptoms of other origin, gynecological malignancy or post-menopausal status were excluded from the analysis. Patients with histologically confirmed endometriosis completed a questionnaire about their psychosocial and clinical characteristics and experiences. Of 173 patients, two did not provide informed consent and were excluded from the study.

MAIN RESULTS AND THE ROLE OF CHANCE

The median interval from the first onset of symptoms to diagnosis was 10.4 (SD: 7.9) years, and 74% of patients received at least one false diagnosis. Factors such as misdiagnosis, mothers considering menstruation as a negative event and normalization of dysmenorrhea by patients significantly prolonged the diagnostic delay. No association was found between either superficial and deep infiltrating endometriosis or oral contraceptive use and the prolongation of diagnosis.

LIMITATIONS AND REASONS FOR CAUTION

There was a possible selection bias due to inclusion of surgically treated patients only.

WIDER IMPLICATIONS OF THE FINDINGS

Several factors causing prolongation of diagnosis of endometriosis have been reported to date. The principal factors observed in the present study are false diagnosis and normalization of symptoms. Teaching programs for doctors and public awareness campaigns might reduce diagnostic delay in Central Europe.

STUDY FUNDING/COMPETING INTEREST(S)

No competing interests exist.

Source:
http://humrep.oxfordjournals.org/cgi/content/short/27/12/3412?rss=1

Recommendation and review posted by G. Smith

Role of prostaglandin E2 in bacterial growth in women with endometriosis

Posted: November 19, 2012 at 3:18 pm

STUDY QUESTION

Can prostaglandin E2 (PGE2) in menstrual and peritoneal fluid (PF) promote bacterial growth in women with endometriosis?

SUMMARY ANSWER

PGE2 promotes bacterial growth in women with endometriosis.

WHAT IS KNOWN ALREADY

Menstrual blood of women with endometriosis is highly contaminated with Escherichia coli (E. coli) compared with that of non-endometriotic women: E. coli-derived lipopolysaccharide (LPS) promotes the growth of endometriosis.

STUDY DESIGN, SIZE AND DURATION

Case-controlled biological research with a prospective collection of body fluids and endometrial tissues from women with and without endometriosis with retrospective evaluation.

PARTICIPANTS/MATERIALS, SETTING AND METHODS

PF and sera were collected from 58 women with endometriosis and 28 women without endometriosis in an academic research laboratory. Menstrual blood was collected from a proportion of these women. Macrophages (M) from PF and stromal cells from eutopic endometria were isolated in primary culture. The exogenous effect of PGE2 on the replication of E. coli was examined in a bacterial culture system. Levels of PGE2 in different body fluids and in the culture media of M and stromal cells were measured by ELISA. The effect of PGE2 on the growth of peripheral blood lymphocytes (PBLs) was examined.

MAIN RESULTS AND THE ROLE OF CHANCE

The PGE2 level was 2–3 times higher in the menstrual fluid (MF) than in either sera or in PF. A significantly higher level of PGE2 was found in the MF and PF of women with endometriosis than in control women (P < 0.05 for each). Exogenous treatment with PGE2 dose dependently increased E. coli colony formation when compared with non-treated bacteria. PGE2-enriched MF was able to stimulate the growth of E. coli in a dilution-dependent manner; this effect was more significantly enhanced in women with endometriosis than in control women (P < 0.05). PGE2 levels in the culture media of LPS-treated M/stromal cells were significantly higher in women with endometriosis than in non-endometriosis (P < 0.05 for each). Direct application of PGE2 and culture media derived from endometrial M or stromal cells significantly suppressed phytohemagglutinin-stimulated growth of PBLs.

LIMITATIONS AND REASONS FOR CAUTION

Further studies are needed to examine the association between PGE2-stimulated growth of E. coli and endotoxin level and to investigate the possible occurrence of sub-clinical infection within vaginal cavity.

WIDER IMPLICATIONS OF THE FINDINGS

Our findings may provide some new insights to understand the physiopathology or pathogenesis of the mysterious disease endometriosis and may hold new therapeutic potential.

STUDY FUNDING/COMPETING INTEREST(S)

This work was supported by grants-in-aid for Scientific Research from the Ministry of Education, Sports, Culture, Science and Technology of Japan. There is no conflict of interest related to this study.

TRIAL REGISTRATION NUMBER

Not applicable.

Source:
http://humrep.oxfordjournals.org/cgi/content/short/27/12/3417?rss=1

Recommendation and review posted by G. Smith

MR-guided focus ultrasound (MRgFUS) for symptomatic uterine fibroids: predictors of treatment success

Posted: November 19, 2012 at 3:18 pm

STUDY QUESTION

What are the factors associated with long-term success in patients with symptomatic uterine fibroids treated by magnetic resonance-guided focus ultrasound (MRgFUS) and can they be employed to create a clinically useful index that predicts long-term efficacy?

SUMMARY ANSWER

Hypo-intense fibroids on T2-weighted magnetic resonance imaging (MRI) and older age were associated with higher success rates and can be used to predict success rates on the basis of their presence or absence as pre-treatment parameters.

WHAT IS KNOWN ALREADY

The signal intensity of baseline T2-weighted MRI images and non-perfused volume at the end of the treatment can be correlated with MRgFUS outcome.

STUDY DESIGN, SIZE AND DURATION

This was a retrospective analysis of 81 patients who were treated by MRgFUS for symptomatic uterine fibroids, in an academic affiliated center between 2003 and 2008.

PARTICIPANTS/MATERIALS, SETTING AND METHODS

There was a post-treatment phone interview >6 months following MRgFUS for symptomatic uterine fibroids.

MAIN RESULTS AND THE ROLE OF CHANCE

The eighty-one patients completed a successful MRgFUS treatment during this period, of whom 74 were included in the final analysis (1 was post-menopausal at treatment and 5 were lost for follow-up). The mean time for the phone interview was 33.0 ± 15.1 months (range: 6–53 months) after the MRgFUS treatment. Fifty-five patients (69%) did not need any additional alternative treatment following MRgFUS. Nineteen patients (24%) underwent other surgical interventions. Hypo-intense fibroids were associated with a higher chance of success than hyper-intense fibroids [odds ratio = 2.96 (1.01–8.71); P = 0.04] for surgery in hyper-intense fibroids). Women with long-term treatment success were significantly older at the time of treatment [46.3 ± 3.8 (range: 37–53) years versus 43.6 ± 4.4 (range: 36–51) years, respectively; P = 0.02].

LIMITATIONS AND REASONS FOR CAUTION

Retrospective non-comparative studies are suboptimal and might overemphasize favorable outcomes.

WIDER IMPLICATIONS OF THE FINDINGS

This paper can contribute to selection of suitable candidates for the MRgFUS treatment for patients with uterine fibroids' and can serve as a guide for gynecologists for a better patient selection.

STUDY FUNDING/COMPETING INTEREST(S)

None.

TRIAL REGISTRATION NUMBER

N/A.

Source:
http://humrep.oxfordjournals.org/cgi/content/short/27/12/3425?rss=1

Recommendation and review posted by G. Smith

How common is adenomyosis? A prospective study of prevalence using transvaginal ultrasound in a gynaecology clinic

Posted: November 19, 2012 at 3:18 pm

STUDY QUESTION

What is the prevalence of adenomyosis in a population of women attending a general gynaecological clinic?

SUMMARY ANSWER

Adenomyosis was present in 206 of 985 [20.9%; 95% confidence interval (CI): 18.5–23.6%] women included in the study.

WHAT IS KNOWN ALREADY

Previous studies of occurrence of adenomyosis have been limited to women who underwent hysterectomy, which is likely to overestimate its prevalence compared with the general population of women. There are no large prospective studies on the prevalence of adenomyosis, either in the general population of women or in a general gynaecology clinic setting.

STUDY DESIGN, SIZE, DURATION

This was a prospective observational study set in the general gynaecology clinic of a university teaching hospital between January 2009 and January 2010.

PARTICIPANTS/MATERIALS, SETTING, METHODS

There were 985 consecutive women who attended the clinic and underwent structured clinical and transvaginal ultrasound examination in accordance with the study protocol. Morphological features of adenomyosis were systematically recorded with the ultrasound scan to determine its prevalence and factors which may affect its occurrence.

MAIN RESULTS AND THE ROLE OF CHANCE

Adenomyosis was present in 206/985 [20.9% (95% CI: 18.5–23.6%)] women included in the study. Multivariate analysis showed that the prevalence of adenomyosis was significantly associated with women's age, gravidity and pelvic endometriosis (P< 0.001). In women who subsequently underwent hysterectomy, there was a good level of agreement between the ultrasound and histological diagnosis of adenomyosis [ = 0.62 (P = 0.001), 95% CI (0.324, 0.912)].

LIMITATIONS, REASONS FOR CAUTION

Our estimate of prevalence of adenomyosis is likely to be higher than in the general population as we studied symptomatic women attending a gynaecology clinic.

WIDER IMPLICATIONS OF THE FINDINGS

Better estimates of the prevalence of adenomyosis can improve our understanding of the burden of the disease, help to identify women at high risk of developing the condition and facilitate the development of preventative strategies and effective treatment.

STUDY FUNDING/COMPETING INTEREST(S)

The authors have no competing interests to declare. The study was not supported by an external grant.

Source:
http://humrep.oxfordjournals.org/cgi/content/short/27/12/3432?rss=1

Recommendation and review posted by G. Smith

Are digestive symptoms in women presenting with pelvic endometriosis specific to lesion localizations? A preliminary prospective study

Posted: November 19, 2012 at 3:18 pm

STUDY QUESTION

What are the types and frequency of digestive symptoms in patients with different localizations of pelvic endometriosis and which specific symptoms are related to rectal stenosis?

SUMMARY ANSWER

There is a high prevalence of digestive complaints in women presenting with superficial pelvic endometriosis and deep endometriosis sparing the rectum.

WHAT IS KNOWN ALREADY

Women presenting with pelvic endometriosis frequently report gastrointestinal complaints of increased intensity during menstruation, which are not necessarily linked to the infiltration of the disease into the rectal wall. Even though intrarectal protrusion of the nodule can have an impact on bowel movement, only a minority of women with rectal nodules seemed to be concerned by significant narrowing of the rectum.

STUDY DESIGN AND SIZE

This three-arm cohort prospective study included 116 women and was carried out over 22 consecutive months.

PARTICIPANTS, SETTING AND METHODS

Prospective recording of data was performed for women treated for Stage 1 endometriosis involving the Douglas pouch (n = 21), deep endometriosis without digestive infiltration (n = 42) and deep endometriosis infiltrating the rectum (n = 53). Patient characteristics, pelvic pain and data from preoperative standardized questionnaires The Gastrointestinal Quality of Life Index (GIQLI), the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS) and the MOS 36-Item Short-Form Health Survey (SF-36) were compared according to endometriosis localization.

MAIN RESULTS

The values of total KESS and total GIQLI score were comparable for the three groups, as were a majority of the digestive complaints. Women presenting with rectal endometriosis were more likely to report an increase in intensity and length of dysmenorrhoea, while deep dyspareunia appeared to be more severe in women with superficial endometriosis. Women presenting with rectal endometriosis were more likely to present cyclic defecation pain (67.9%), cyclic constipation (54.7%) and a significantly longer stool evacuation time, although these complaints were also frequent in the other two groups (38.1 and 33.3% in women with Stage 1 endometriosis and 42.9 and 26.2% in women with deep endometriosis without digestive involvement, respectively). No independent clinical factor was found to be related to infiltration of the rectum by deep endometriosis. Among women with rectal endometriosis, only 26.4% presented with rectal stenosis. These women were significantly more likely to report constipation, defecation pain, appetite disorders, longer evacuation time and increased stool consistency without laxatives.

LIMITATIONS

Patients treated for pelvic endometriosis in a tertiary referral centre may not be representative of the general endometriosis population presenting with those lesions. Statistically significant differences were revealed between the three groups; however, the results were based on a small number of subjects, which carries an inherent risk of type II error particularly when comparing variables with closed values.

WIDER IMPLICATIONS OF THE FINDINGS

In women presenting with pelvic endometriosis, it seems likely that various digestive symptoms are the consequence of cyclic inflammatory phenomena leading to irritation of the digestive tract, rather than to actual infiltration of the disease itself into the rectum, with the exception of a limited number of cases where the disease leads to rectal stenosis.

STUDY FUNDING/COMPETING INTEREST

The North-West Inter Regional Female Cohort for Patients with Endometriosis (CIRENDO) is financed by the G4 Group (The University Hospitals of Rouen, Lille, Amiens and Caen). No financial support was specifically received for this study. The authors declare no conflict of interest.

Source:
http://humrep.oxfordjournals.org/cgi/content/short/27/12/3440?rss=1

Recommendation and review posted by G. Smith


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