World’s first baby born after transplant of ovarian tissue frozen before puberty at age 9.

 Moaza Al Matrooshi from Dubai, becomes the first woman to give birth to a healthy baby boy after transplant of her ovarian tissue  that was frozen prepubescent at age 9.

Over 60 children have been born to women who have undergone ovarian tissue transplants worldwide, but all these patients were adults when the ovarian tissue was preserved.

She is at present 24 and the frozen ovarian tissue was replanted about a year back.  Moaza was born with beta thalassemia and needed bone marrow transplant to save her life.

She had to have chemotherapy before she was set to receive bone marrow transplant. Her right ovary was removed cut into strips, frozen, and stored at a hospital in Leeds. It was mixed with cryoprotective agent and stored at -196 C in liquid nitrogen.

Moaza received the chemotherapy and bone marrow transplant, but attained a premature menopause at 20 years of age due to chemotoxicity.

About a year back surgeons in Denmark replanted five strips of the ovarian tissue back into her body - four were stitched on to her failed left ovary and one on to the side of her uterus.

The ovarian tissue gained blood supply and started functioning as was evident from rising hormonal levels and evidence of ovulation. Moaza underwent IVF to maximize the chances of conception.

Two embryos were transplanted resulting in the birth of healthy baby boy on Tuesday, December 15 in London at the Portland Hospital for Women and Children. 

Moaza Al Matrooshi with her husband and baby boy: JOE MILES / AFP/GETTY IMAGES

The medical community was overjoyed and celebrated the birth of the boy as it paved the way to restoring fertility to women who receive chemotherapy at an early age. Survival rates for children with cancers have reached 90%, but they get the life back and loose the fertility.

Dr. Sara Matthews who was Moaza’s obstetrician and gynecologist said "This is a huge step forward. We know that ovarian tissue transplantation works for older women, but we've never known if we could take tissue from a child, freeze it and make it work again. This is moving from an experimental technique to a practical application."

Scientists in Leeds were pioneer in performing the world's first transplant of frozen ovarian tissue back in 1999.

Last year a woman in Belgium also gave birth after transplant of her ovarian tissue removed when she was 13 years old and have entered puberty. The first woman in the world to give birth following the transplantation of her own ovarian tissue in 2004 also happened to be from Belgium.

Sources:

The mirror,UK

The Guardian

British Fertility Society

The Telegraph

American Cancer Society.

Applicator-free novel vaginal estradiol softgel capsule promising in relieving vaginal atrophy.

Vagicap. Courtesy: TherapeuticsMD

Vulvovaginal atrophy affects nearly half of the postmenopausal women in the United States.[1] It is often termed as ‘the silent epidemic’ as most of the women are reluctant to seek medical advice due to cultural, social reasons. Adverse publicity of Hormone Replacement Therapy(HRT) also plays a major role in preventing women from discussing the symptoms with a healthcare professional.[2]

Results of a phase 3 REJOICE trial investigating a novel drug delivery system for estradiol have shown promising results in relieving symptoms of postmenopausal vulvovaginal atrophy.

This product which goes by the name of TX-004HR is being developed by TherapeuticsMD, Inc, BOCA RATON, Florida. The results from the pivotal phase 3 Rejoice Trial were presented at Endocrine Society’s 98^th Annual Meeting and Expo, being held April 1-4, 2016, in Boston and American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting held May 14-17, 2016, in Washington, DC.

TherapeuticsMD is using the unique technology called ‘SYMBODA’ in manufacturing the softgel capsules conditionally named as Yuvvexy™. SYMBODA, meaning “similar to the body,” is a solubilized female hormone technology for formulation of estradiol and progesterone identical in chemical structure to the estradiol and progesterone that women naturally produce.[3]  The drugs are dissolved in medium-chain oils enabling content uniformity and accurate dosing. Vagicap is an applicator free, vaginal-mucosal adhesive, soft gel capsule containing low-dose solubilized 17β-estradiol.[4]

Applicator free Vagicap . TherapeuticsMD

The results of the trial were published online in the forthcoming issue of Menopause. REJOICE was a randomized, double-blind, placebo-controlled, phase 3 study of 764 postmenopausal women who complaint of bothersome dyspareunia and vulvovaginal atrophy (VVA). They were treated with 4, 10, or 25 [mu]g TX-004HR or placebo for 12 weeks. Women received treatment once daily for 2 weeks, then twice weekly for 10 weeks.

Female Sexual Function Index (FSFI) questionnaire were administered to all the participants at baseline and at 12 weeks. It consists of 19 questions covering six domains of sexual function.

Significant improvement was seen (P < 0.0001) in co-primary endpoints of percentages of superficial and parabasal cells, vaginal pH other than dyspareunia at 2 weeks.

Dyspareunia, vaginal dryness and irritation all improved at the end of study. FSFI scores also showed a significant improvement with all the doses of TX-004HR.

The drug was well tolerated with no serious side effects. Blood levels of estradiol remained at pretreatment level throughout the study.

The authors concluded that “The present Female Sexual Function Index (FSFI) data coupled with improvement in vaginal physiology suggest that TX-004HR could be a promising treatment option for VVA, with a potential added benefit of improving Female Sexual Dysfunction (FSD) in postmenopausal women.

Dr Bernick, Julia M. Amadio and Sebastian Mirkin, MD are employed by TherapeuticsMD.

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[1] http://www.endocrinologyadvisor.com/endo-2016/endo-vaginal-capsule-may-relieve-vulvar-vaginal-atrophy/article/490044/

[2] https://core.ac.uk/download/pdf/36770934.pdf

[3] https://www.therapeuticsmd.com/research/symboda-technology

[4] http://www.sciencedirect.com/science/article/pii/S1743609516304040

Proposed ban finalized: FDA bans use of all powdered medical gloves in U.S hospitals.

image courtesy: Mcfarlane Medical Equipment

The US FDA issued a very important rule on Friday banning the use of powdered gloves beginning January 19, 2017. The FDA stated in the press release “While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.”[1]

The ban includes powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.

The ban is not for powder used in manufacturing process that is not a part of the finished product.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

Earlier, the ban was proposed on March 21, 2016 but was not finalized.[2]

Before proposing the ban, FDA considered all available scientific evidence in disease causation due to powder which included a thorough review of literature. FDA has also received several public petitions from 1997 to 2011, requesting a ban due to multiple health issues in doctors and healthcare workers.

Over the year’s organizations such the American Academy of Allergy, Asthma, and Immunology(ACAAI), the National Institute for Occupational Safety and Health (NIOSH), the American College of Surgeons (ACS), and the American Nurses Association have all issued statements against the use of powdered gloves. CDC also joined the team, issuing a statement on NRL sensitization and recommending that non-powdered rubber latex gloves would be more efficient.

Moreover, health care systems such as the Cleveland Clinic network of nine hospitals, the Johns Hopkins Hospital and University of Virginia Healthcare systems have all restricted or banned the use of powdered NRL gloves in their systems. In Europe, Germany and the United Kingdom have also taken steps against use of powdered NRL gloves.

All powdered gloves are associated with multiple health risks like acute severe airway inflammation, granulomas, peritoneal and other tissues adhesions including tubal adhesions and infertility.  Allergic reactions include asthma, allergic rhinitis, conjunctivitis, and dyspnea. Additionally, the latex sensitive individuals experience cutaneous reactions upon skin exposure to the latex allergenic proteins adherent to the powder.

Surgical gloves made room in doctor’s armamentarium in the year 1889, and have played an important role in protecting both patients and health care personnel in medical field since then. Various types of powder lubricants have been used so that they can be donned easily. The first was powder made from Lycopodium spores (club moss spores) and later replaced by talcum powder (chemically hydrous magnesium silicate). Both were replaced by modified cornstarch as they were recognized to cause wound granulomas and adhesion formation.  Cornstarch is currently the most commonly used type of absorbable glove powder.

FDA encourages people in heathcare industry to use non-powdered gloves which contains minimum amount of powder (no more than 2 milligrams). Non-powdered gloves are easily available in the market and FDA believes “This ban would likely have minimal economic and shortage impact on the health care industry. Thus, a transition to alternatives in the marketplace should not result in any detriment to public health.”

We are in. image courtesy: shopdirectsource.com

www.esafetysupplies.com

FDA also believes that the ban will not incur any additional expenses on the part of society and it will be beneficial in terms of cost and reducing the number of complications.  Annual net benefits between $26.8 million and $31.8 million in healthcare cost  is expected by FDA.

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[1] https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder

[2] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491466.htm