Τhe American College of Obstetrician and Gynecologists Practice Advisory for corona virus

Dr. Kouzi

Τhe American College of Obstetrician and Gynecologists Practice Advisory: Novel Coronavirus 2019 (COVID-19)

March 13, 2020

The American College of Obstetricians and Gynecologists (ACOG) is closely monitoring the COVID-19 pandemic. Imported cases of COVID-19 infection in travelers have been detected in the United States, and person-to-person spread of COVID-19 also has been seen among close contacts of returned travelers from Wuhan. Community spread of COVID-19 has also been reported in several states.

The Centers for Disease Control and Prevention (CDC) has released Interim Clinical Guidance for Management of Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) Infection and guidance for Evaluating and Reporting Persons Under Investigation (PUI).

Travel

Due to the current risk of COVID-19, CDC is continually updating travel recommendations. Please see CDC’s Coronavirus Disease 2019 Information for Travel page for the most up to date information on travel recommendations and restrictions.

Additional travel advisories or restrictions may be implemented globally and locally within the United States depending on community spread. Ob-gyns and other health care practitioners should check with their local and/or state health department for guidance on travel restrictions in their area.

Testing

Testing is currently occurring at state and local public health laboratories in 50 states and the District of Columbia. Ob-gyns and other health care practitioners should contact their local and/or state health department for guidance on testing persons under investigation.

Pregnant Women

The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have developed an algorithm to aid practitioners in assessing and managing pregnant women with suspected or confirmed COVID-19. View the algorithm.

At this time, very little is known about COVID-19, particularly related to its effect on pregnant women and infants, and there currently are no recommendations specific to pregnant women regarding the evaluation or management of COVID-19.

Currently available data on COVID-19 does not indicate that pregnant women are at increased risk. However, pregnant women are known to be at greater risk of severe morbidity and mortality from other respiratory infections such as influenza and SARS-CoV. As such, pregnant women should be considered an at-risk population for COVID-19. Adverse infant outcomes (eg, preterm birth) have been reported among infants born to mothers positive for COVID-19 during pregnancy. However, this information is based on limited data and it is not clear that these outcomes were related to maternal infection. Currently it is unclear if COVID-19 can cross through the transplacental route to the fetus. In limited recent case series of infants born to mothers infected with COVID-19 published in the peer-reviewed literature, none of the infants have tested positive for COVID-19 (1).

While travel history is always an essential component of medical history intake, obstetrician–gynecologists and other health care practitioners should be vigilant in obtaining a detailed travel history as well as a history of exposure to people with symptoms of COVID-19 for all patients, including pregnant women presenting with fever or acute respiratory illness and should follow the CDC’s Interim Clinical Guidance for Management of Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) Infection and guidance for Evaluating and Reporting Persons Under Investigation (PUI). Of note, health care practitioners should immediately notify infection control personnel at their health care facility and their local or state health department in the event of a PUI for COVID-19.

Community Mitigation Efforts

Community mitigation efforts to control the spread of COVID-19 are being implemented across the United States. While these efforts are important, ob-gyns and other health care practitioners should be aware of the unintended impact they may have, including limiting access to routine prenatal care. Ob-gyns and other prenatal care practitioners should ensure that patients with certain high-risk conditions are provided necessary prenatal care and testing when needed. Ob-gyns and other prenatal care practitioners should also consider creating a plan to address the possibility of a decreased health care workforce, potential shortage of personal protective equipment, limited isolation rooms, and should maximize the use of telehealth across as many aspects of prenatal care as possible.

Infection Prevention and Control in Inpatient Obstetric Care Settings

The CDC has published Interim Considerations for Infection Prevention and Control of Coronavirus Disease 2019 (COVID-19) in Inpatient Obstetric Healthcare Settings. These considerations apply to health care facilities providing obstetric care for pregnant patients with confirmed COVID-19 or pregnant persons under investigation (PUI) in inpatient obstetric health care settings including obstetrical triage, labor and delivery, recovery and inpatient postpartum settings.

The American College of Obstetricians and Gynecologists encourages physicians and other obstetric care practitioners to read and familiarize themselves with the complete list of recommendations.

Key highlights from the recommendations include:

·         Health care practitioners should promptly notify infection control personnel at their facility of the anticipated arrival of a pregnant patient who has confirmed COVID-19 or is a PUI.

·         Patients with known or suspected COVID-19 should be cared for in a single-person room with the door closed. Airborne Infection Isolation Rooms should be reserved for patients undergoing aerosol-generating procedures.

·         Facemasks are an acceptable alternative when the supply chain of respirators cannot meet the demand. During this time, available respirators should be prioritized for procedures that are likely to generate respiratory aerosols. When the supply chain is restored, facilities with a respiratory protection program should return to use of respirators for patients with known or suspected COVID-19.

·         Infants born to mothers with confirmed COVID-19 should be considered PUIs. As such, these infants should be isolated according to the Infection Prevention and Control Guidance for PUIs.

·         To reduce the risk of transmission of the virus that causes COVID-19 from the mother to the newborn, facilities should consider temporarily separating (eg, separate rooms) the mother who has confirmed COVID-19 or is a PUI from her baby until the mother’s transmission-based precautions are discontinued.

·         Discharge for postpartum women should follow recommendations described in the Interim Considerations for Disposition of Hospitalized Patients with COVID-19.

Due to the limited data on COVID-19, these recommendations are largely based on infection prevention and control considerations for other respiratory viruses such as influenza, SARS-CoV and MERS-CoV and are intentionally cautious as experts learn more about this new virus.

Breastfeeding

The CDC has developed Interim Guidance on Breastfeeding for a Mother Confirmed or Under Investigation for COVID-19. There are rare exceptions when breastfeeding or feeding expressed breast milk is not recommended. Whether and how to start or continue breastfeeding should be determined by the mother in coordination with her family and health care practitioners. Currently, the primary concern is not whether the virus can be transmitted through breastmilk, but rather whether an infected mother can transmit the virus through respiratory droplets during the period of breastfeeding. A mother with confirmed COVID-19 or who is a symptomatic PUI should take all possible precautions to avoid spreading the virus to her infant, including washing her hands before touching the infant and wearing a face mask, if possible, while breastfeeding. If expressing breast milk with a manual or electric breast pump, the mother should wash her hands before touching any pump or bottle parts and follow recommendations for proper pump cleaning after each use. If possible, consider having someone who is well feed the expressed breast milk to the infant.

In limited case series reported to date, no evidence of virus has been found in the breast milk of women infected with COVID-19; however, it is not yet known if COVID-19 can be transmitted through breast milk (ie, infectious virus in the breast milk).

Precautions for Health Care Personnel

The CDC recommends that all health care personnel who enter the room of a patient with known or suspected COVID-19 (persons under investigation) should adhere to Standard, Contact, and Airborne Precautions. See the CDC’s Interim Infection Prevention and Control Recommendations for Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) or Persons Under Investigation for 2019-nCoV in Healthcare Settings for detailed recommendations.

Pregnant healthcare personnel (HCP) should follow risk assessment and infection control guidelines for HCP exposed to patients with suspected or confirmed COVID-19. Facilities may want to consider limiting exposure of pregnant HCP to patients with confirmed or suspected COVID-19, especially during higher risk procedures (e.g., aerosol-generating procedures) if feasible based on staffing availability.

Additional Information

Currently, health officials are emphasizing that seasonal influenza remains a persistent concern for the U.S. population. Influenza activity continues to be high across the United States, and health care practitioners are encouraged to continue offering influenza vaccine to their unvaccinated patients, particularly pregnant women. For more information on seasonal influenza and recommendations for pregnant women see the CDC’s website and ACOG’s Clinical Guidance.

The American College of Obstetricians and Gynecologists will continue to closely monitor the evolution of the 2019 novel coronavirus (COVID-19) in collaboration with the CDC. New and updated information will be shared as it becomes available.

This Practice Advisory was developed by the American College of Obstetricians and Gynecologists’ Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group in collaboration with Laura E. Riley, MD; Richard Beigi, MD; Denise J. Jamieson, MD, and Brenna L. Hughes MD.

References

1.     Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, et al. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet 2020; DOI: 10.1016/S0140-6736(20)30360-3. Available at: http://www.sciencedirect.com/science/article/pii/S0140673620303603. Retrieved Feb 21, 2020.

 

Precision medicine using autologous young stem cells

Dr. Kouzi

Preventive personalized medicine starts at birth

Professor George Koliakos

“Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals.”

President Obama, January 30, 2015 - The precision Medicine initiative

https://obamawhitehouse.archives.gov/precision-medicine

Every human being is genetically unique. Therefore, the same therapy is not always successful to every patient with the same disease.

Personalized or precision Medicine exactly matches each preventive, diagnostic or therapeutic approach to each patient’s unique individual characteristics.

Personalized medicine also includes the creation of biopharmaceuticals and biological products designed precisely for the particular individual—e.g., "...patient-specific tissues, organs or organoids to tailor treatments for a certain patient." These must be genetically matched with the patient, originating from his own cells. Stem cell research today holds an enormous potential for the therapy of several diseases that were considered fatal or non treatable, including the creation of replacement cells, tissues and even organs and tools for drug screening. These cell-based systems and therapies are created using autologous (patient-derived) stem cells, offering thus a basis for incredibly sophisticated individualized biopharmaceuticals with maximum therapeutic efficacy.

Stem cells that can be collected after birth are defined as “Adult Stem Cells”. Adult stem cells are today the successful golden standard for novel individualized therapies. A rapidly growing treasure in the medical literature of clinically validated applications has been already accumulated.

The only successful and clinically applicable stem cell types today are Adult stem cells, and this justifies the amounts of money invested in this field. Adult stem cell applications surpassed 1 million people around the globe by the end of 2012 and their clinical applications are increasing rapidly in most medical specialties. https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.118.313664

These most valuable individual stem cells, saved for the future patient can be collected upon birth and cryopreserved today in Biohellenika’s accredited laboratories.

Published clinical research suggest potential cardiovascular applications, treatment of type I diabetes and spinal cord injury using umbilical cord blood and cord tissue–derived cells. Striking results have been reported to treat neurological conditions, including cerebral palsy, autism, multiple sclerosis and stroke. Adult stem cells are also used as vehicles for genetic therapies using novel gene modification tools such as transposons or CRISPR technology. https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.118.313664 http://info.cell.com/cell-press-selection-stem-cells-toward-precision-medicine-ms

However, every patient, every human being is unique, therefore young cells from the same patient will be always needed.

Young cells from the same patient can be painlessly collected in large amounts only at birth, and only if the caring parents consider to collect these cells upon birth.

We store more cells than anybody else

Hematopoietic stem cells

Our proprietary technology, yields more cells than any other conventional method.

More than 98% of red blood cells are eliminated and therefore storage volume is only 6 ml.

The yield of Stem cell is 99+/-1%

A small amount of the toxic Cryopreservant DMSO is used because of the small volume.

There is no need of further processing after defreezing, so we do  not lose cells

Additional, proprietary, ex utero collection can give units sufficient for therapy .

Multiplication technologies are under development.

Mesenchymal stems

Our proprietary technology uses the whole length of umbilical cord to produce millions of cells.

We store cells ready for use and not tissue parts, as conventional methods do.

These cells can be used for todays mesenchymal stem cell therapies or become the raw materials for personalized biopharmaceuticals of the future. These cells can also multiplied if more cells are needed.

Young Immune system cells

The raw material for personalized immunotherapy

Newborn immune system cells such as monocytes and lymphocytes are stored. Lymphocyte populations such as T reg cells and NK cells can be today multiplied and used for autologous immunotherapies. T lymphocytes can be the raw material for the production of autologous biopharmaceuticals such as Car-T cells for cancer therapy. Monocytes can produce dentritic cells a basis for specified personalized vaccines

A multitude of new possibilities for the use of these stored immune cells is rising.

VSEL cells

The future of personalized medicine

Only in our company, using proprietary technology, VSEL cells can be stored in a separate cryovial.

These cells are the mother cells of any other stem cell in the organism and can derive any other type of adult stem cell in the lab, including sperm and oocytes. VCEL cells can be multiplied without loosing their differentiation capacity.

Experience of more than 40000 collections

Biohellenika advice to stay home

Dr. Kouzi

Dear Parents

By participating in the  general mobilization of the state-run home stay-orders, Biohellenika recommends that expectant mothers avoid moving. They will be served by the company 24 hours a day, to send or to pick up kits. The company is functional as usual and did not change any of its schedulle. In the event of a shutdown, the call center and the lab will be operational and immediate communication and service will continue as normal.

The contact phones are:

 2310 474282, 210 7708882, 6944 677 746, 6974 729 820

We  hope  the situation will end soon and  all be back to normal and healthy.

On behalf of Biohellenika’s staff

Health and strength to all

Distinction of Biohellenika

Dr. Kouzi

Biohellenika is always present in innovation

Biohellenika attends 70^th Congress of the Greek Society of Biochemistry and Molecular Biology

Biohellenika won another distinction at the 70^th congress of the Greek Society of Biochemistry and Molecular Biology in Athens on 29/11/2019-2/12/2019.

The Research &Development Department of Biohellenika has for the first time developed an innovative system of combined application of adipose tissue stem cells and time-controlled release of anti-angiogenic drugs by nanofibers with the aim of addressing retinopaties. There are no effective treatments for retinal diseases as most of them delay the onset of clinical symptoms rather to reverse the main pathophysiology of the disease. For this reason most of the patients and to blindness. The only promising treatment today are cellular therapies using stem cells. However, limitations related to the pathological  environment in the diseased tissue make it difficult to  provide such forms of the treatment.

For the first time we propose in this study a system of gradual reduction of abnormal neovascularization in the retina using specially constructed biomaterials carrying ant-angiogenic agents accompanied by adipose tissue stem cells administration. The combination therapy we propose is already being in animal models of induced retinal damage.