First live birth after deceased donor uterine transplant takes place at the Cleveland clinic

This June 18, 2019 photo provided by the Cleveland Clinic 

Cleveland Clinic in Ohio becomes the first hospital in North America to deliver a baby born out of uterus that was transplanted after the donor was deceased.

The mother, who is in her mid-30s, is part of a groundbreaking research trial involving 10 women with uterine factor infertility, who are all destined to receive uterus from deceased donors.  Since the start of the trial, the team has performed 5 uterine transplants, of which 3 were successful, including the one which resulted in a live birth. Two other women are waiting for embryo transfer.

The baby was delivered “en caul,” meaning the amniotic sac remained intact until after the delivery. This is an extremely rare but safe occurrence and happened spontaneously with this delivery, adding to the special occasion. The woman whose identity was not disclosed chose to remove the uterus after delivering the baby.

This is the second birth from a uterus from a deceased donor, the first occurred in 2017 in a Brazilian trial involving a 32-year-old woman born without a womb who received a uterine transplant from a 45-year-old woman who'd died of a stroke.

Here is the video from Cleveland Clinic

First medical device developed to filter blood to treat preeclampsia

courtesy: APT

The U.S. Food and Drug Administration (FDA) granted a Breakthrough Device Designation for the Advanced Prenatal Therapeutics, Inc. (APT) Targeted Apheresis Column for Preeclampsia (TAC-PE) in the treatment of preeclampsia.

Currently, the therapeutic options for preeclampsia are limited and include bed rest, anti-hypertensive medications and induction of preterm labor if needed.

The TAC-PE column is an apheresis device that works like kidney dialysis in selectively removing the harmful substances from the blood. While the exact cause of preeclampsia is not known, several biomarkers have been identified that are responsible for life-threatening preeclampsia symptoms like kidney and liver dysfunction and high blood pressure.

The apheresis procedure resembles voluntary blood donation. The woman’s blood is pumped through the apheresis machine to separate it into plasma and blood cells. The plasma then passes through the TAC-PE device, where the toxic substances are captured. The toxin-free plasma is mixed with the cells and returned to the patient.

APT first therapeutic target is soluble fms-like tyrosine kinase-1 (sFlt-1). The circulating sFlt-1is made by the placenta and antagonizes the action of Vascular endothelial growth factor (VEGF), that triggers new vessel formation and vasodilatation in normal pregnancies. Pre-eclampsia occurs when the relative functional activity sFlt-1 exceeds that of VEGF resulting in vasoconstriction in important organs like kidney, liver, and brain (the organs most affected by preeclampsia).

Removal of sFlt-1 from blood helps to restore the vascular homeostasis by alleviating the endothelial dysfunction. This eliminates the need for premature termination of pregnancy, helps stabilize the mother and baby to let the pregnancy proceed naturally to term.

“We were navigating virtually uncharted waters in 2005 when we first proposed that preeclampsia could be treated using an apheresis column to remove pathogenic factors such as sFlt-1,” said Dr. James Smith, President/CEO of APT. “Now that we are preparing for initial clinical studies, we are very pleased that the Breakthrough Designation will help provide a clear and efficient pathway to market.”

APT is a Laguna Hills, California based company involved in developing an effective treatment that will safely prolong pregnancy, allowing babies more time to develop in the womb in patients with preeclampsia.

TAC-PE: TARGETED APHERESIS COLUMN FORPREECLAMPSIA

Advanced Prenatal Therapeutics PressRelease…

Here is a video from APT

FDA approves a new drug for increasing libido in premenopausal women

Courtesy: AMAG Pharmaceuticals

The US Food and Drug Administration (FDA) recently approved bremelanotide (Vyleesi, AMAG Pharmaceuticals), for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

Vyleesi, a melanocortin receptor agonist that comes as autoinjector, joins flibanserin(Addyi, Sprout Pharmaceuticals) as the class of drugs approved by the FDA for the treatment of acquired HSDD. Flibanserin is Serotonin 5-HT-Receptor Agonists and is taken orally.

HSDD is the most commonly prevalent female sexual dysfunction and is largely under-recognized and undertreated. It is believed that approximately 9% of all premenopausal women in the United States experience it but less than half of these patients seek help or initiate discussions with physicians.

 “Women with HSDD often avoid situations that could lead to intimacy, the impact of which goes far beyond the bedroom and can often result in anxiety, loss of vitality, self-esteem issues and relationship stress. It is important that women suffering from this condition have a choice of treatment options available to them,” quote Anita H. Clayton, M.D., Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, VA in an AMAG Pharma news release.

The upside of bremelanotide is women need to use it as required as opposed to flibanserin which must be consumed daily.  The drug is dispensed as prefilled autoinjector pen which has to be self-administered by the woman into her abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day.

Courtesy: AMAG Pharmaceuticals

Patients should not use more than one dose within 24 hours or more than eight doses per month. Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.

While the exact mechanism of action is still unknown, the drug is believed to act on the melanocortin receptors in the central nervous system that are thought to be associated with sexual function.

The FDA approval of Vyleesi is based upon data from approximately 1,247 women in two pivotal (NCT02333071 and NCT02338960), replicate, double-blind placebo-controlled Phase 3 trials (RECONNECT). Most patients used the drug 2-3 times a month with no more than once a week.

Vyleesi does not enhance sexual performance, but there was a statistically significant increase in desire and decrease in distress at the time of intimacy. Women in both the trials didn’t experience any problem with the autoinjector.

The most common side effects of Vyleesi are nausea and vomiting, flushing, injection site reactions, and headache. An increase in blood pressure was also noted, which usually resolved in 12 hours. Hence, Vyleesi is contraindicated in patients at high risk of cardiovascular disease and those with high-blood pressure.

Vyleesi is not indicated for the treatment of HSDD in postmenopausal women or in men. AMAG is expected to make Vyleesi commercially available in September 2019 through select specialty pharmacies.

FDA press release

AMAG Pharmanews release