Coronavirus And Pregnancy
Pregnancy concerns associated with the ongoing Coronavirus pandemic and its resulting disease COVID-19 are inevitable for all the new parents and parents-to-be out there. To put your worries at rest, we have addressed some of the most common queries on every parent’s mind in this section. The content is adapted based on guidelines from agencies like CDC, ACOG, RCOG, FOGSI, ICMR and scientific publications so far. However, they are simplified and made user friendly for Indian context. The purpose of this page is to only provide basic information and our viewers are encouraged to follow the instructions of their own healthcare professionals.
1. Stay at home
2. Wash your hands at regular intervals
3. Cover your mouth while coughing/sneezing
4. Avoid touching your face
5. Keep a minimum distance of 1 metre from others
Coronavirus And Cord Blood Banking
Medical scientists are learning more every day about the coronavirus. Among the questions about the pandemic and the COVID-19 disease are some pertaining to umbilical cord blood banking. LifeCell has prepared known answers for commonly asked questions.
Cord Blood Banking is safe and LifeCell has made it safer by modifying its Maternal Health History and Antenatal History Questionnaire to obtain and document a detailed travel history, history of exposure to people with symptoms of COVID-19, and development of symptoms of COVID-19 and immunocompromised conditions, prior to banking their newborn’s stem cells. This is our voluntary precautionary measure even though the current studies show that the coronavirus is not expected to appear in the umbilical cord blood. The philosophy is to collect the information now in case it becomes important later. Currently, there are no regulatory requirements necessitating the same. We have not had to change our collection procedures because the cord blood is collected by our trained staff under the supervision of the attending obstetrician inside a sterile delivery room anyway. We are closely monitoring and following national and international best practices across our laboratories and offices to mitigate risks associated with Coronavirus Disease 2019 (COVID-19).
Additionally, LifeCell has also launched the COVID-19 Testing for Asymptomatic Pregnant Women as per the recent ICMR Recommendation in Association with ICMR Approved Partner Laboratories.
- Currently, the services would be available only in Mumbai, Pune, Chennai, Bengaluru, Delhi, Nasik, Nagpur, Kolhapur, Aurangabad and Ahmedabad with more cities being added periodically.
- The test will be done only upon a Qualified Doctor's Prescription.
- Our Customer Care team will call the responses and share the payment link to Clients. They will also collect 3 documents to initiate the process: Doctor’s Prescription, Government Photo ID Proof, Duly Filled Clinical Information Form From Partner Lab.
- Sample collection will be done by a trained technician from the partnered lab wearing PPE (Personal Protective Equipment).
- Reports shall also be taken care of Hence, you can be completely assured about the safety and quality of the umbilical cord blood stem cells banked with LifeCell.
- TAT for Report is 24 hours.
- Test fees is only INR 4500/-
- For more information click here: https://www.lifecell.in/covid-19-test-at-home
Coronavirus And Potential of Stem Cells To Combat COVID-19
Stem cells have been creating quite a stir in the healthcare industry owing to its growing potential in the possible treatment of COVID-19. Multiple therapeutic companies have begun clinical trials using stem cells for the management of the symptoms associated with the infection. This section is to keep you updated about everything related to stem cells and coronavirus and its resulting disease - COVID-19
Could Cord Blood Help Treat COVID-19?
- American Scientists Look Confident: A recent COVID-19 treatment protocol submitted by The American Academy of Stem Cell Physicians (AASCP) to the World Health Organisation (WHO) recommends Cord Blood as an integral part of the regimen. This recommendation was soon released after a number of studies proposing potential utility of cord blood cells in the treatment and control of the COVID-19 pandemic.
- Novel Cord Blood Technology To Treat SARS-CoV-2: In another study, researchers demonstrated that the clinical autopsies from COVID-19 patients had major pathological changes in the lungs, immune organs, and small systemic blood vessels as a result of immune overreactions. Tianhe Stem Cell Biotechnologies Inc., USA has therefore, developed a novel globally-patented Stem Cell Educator (SCE) technology that uses human multipotent cord blood stem cells to control this immune overreaction witnessed during autoimmune conditions such as Type1 Diabetes. The investigators plan to treat SARS-CoV-2 patients with this SCE therapy.
- Cord Blood NK Cells Could Hold The Key: Umbilical cord blood contains natural killer (NK) cells which exhibit a unique property in targeting virus-infected cells. Of late, with the sudden outbreak of the deadly coronavirus, the need for an “off-the-shelf” treatment that the patients can have quick access to has increased. MD Anderson Cancer Center in the US has recently begun targeting the study of NK cells. The researchers there are isolating these fighter cells from the extracted cord blood and using them in their original form and also developing them into a CAR-NK cell product. What makes cord blood-derived NK cells of more importance is the fact that there is a more rapid recovery of NK cells reported after umbilical cord blood transplants (UCBT) than peripheral blood hematopoietic stem cell transplantation (PB-HSCT). As research continues to bridge the gap between the unknown and the proven, we may see the popularity in NK Cells and Umbilical Cord Blood products rise in future.
- Summary of Clinical Trials Using Cord Blood To Treat COVID-19:
Sr.No. Clinical Trial ID Country Intervention Institution 1 ChiCTR2000029818 China Cord Blood Plasma Guangzhou Reborn Health Management Consultation Co., Ltd 2 ChiCTR2000029817 China Cord Blood - Natural Killer (NK) Cells Guangzhou Reborn Health Management Consultation Co., Ltd 3 ChiCTR2000030329 China Cord Blood - Cytokine-induced killer cell (CIK) And NK Cells The Second Affiliated Hospital of Xi'an Medical University 4 ChiCTR2000029569 China Cord Blood - Mononuclear Cells (MNC) Conditioned Medium Xiangyang No.1 People's Hospital 5 ChiCTR2000029572 China Cord Blood - Mononuclear Cells (MNC) Xiangyang No.1 People's Hospital 6 ChiCTR2000029816 China Cord Blood - Mesenchymal Stem Cells (MSCs) Guangzhou Reborn Health Management Consultation Co., Ltd 7 ChiCTR2000029812 China Cord Blood - Mononuclear Cells (MNC) Guangzhou Reborn Health Management Consultation Co., Ltd 8 ChiCTR2000031735 China Cord Blood - Natural Killer (NK) Cells Huzhou Central Hospital
Could MSCs Treat COVID-19 Complications Like Pneumonia And ARDS?
- MSCs Shows Intriguing Potential To Treat COVID-19:
Since the novel coronavirus COVID-19 emerged, there has been a surge in clinical trials deploying MSCs to treat the respiratory complications of COVID-19, which include pneumonia and Acute Respiratory Distress Syndrome (ARDS). Years of research have clearly established that MSCs are anti-inflammatory and immune-modulatory, so it makes sense that MSC could be beneficial to treat the lung inflammation and cytokine storm caused by COVID-19. As on 15th April, 2020 there have been a total of 44 COVID-19 related therapeutic clinical trials registered and 70% of them (31) employ some form of MSC.
- Cure Alliance, USA Launches 24-Patient Trial Using Donated UC-MSCs Against COVID-19:
An international team of scientists led by Dr. Camillo Ricordi has been granted immediate US Food and Drug Administration (US FDA) authorization for a 24-patient clinical trial to prevent the life-threatening lung inflammation that accompanies severe cases of COVID-19. The cell therapy will be administered to patients intravenously. The trial is sponsored by The Cure Alliance, a non-profit group of scientists and innovators dedicated to sharing knowledge and accelerating cures for all diseases.
- Promise Of Donated Umbilical Cord Tissue MSCs To Treat COVID-19:
In a study from China it was shown that eight patients were successfully treated using MSCs. Among them, 2 were critically ill. The first that defeated COVID-19 with mesenchymal stem cells was a 65-year-old woman. 7 other patients were also successfully treated for the infection in Beijing. MSCs are safe and could reverse severe critical disease with high potency. They are thus a major breakthrough representing an entirely new biological approach to treatment that needs to be developed urgently for battling COVID-19 successfully.
- Summary of Few Clinical Trials Using Umbilical Cord Tissue MSCs To Combat COVID-19:
Sr.No. Clinical Trial ID Country Intervention Institution 1 NCT04269525 China Donated Umbilical Cord MSCs Zhongnan Hospital of Wuhan University 2 NCT04273646 China Donated Umbilical Cord MSCs Wuhan Union Hospital 3 ChiCTR2000030088 China Donated Umbilical Cord MSCs The Sixth Medical Center of PLA General Hospital 4 ChiCTR2000030116 China Donated Umbilical Cord MSCs Chinese PLA General Hospital 5 ChiCTR2000030173 China Donated Umbilical Cord MSCs Hunan Yuanpin Cell Biotechnology Co., Ltd 6 ChiCTR2000030138 China Donated Umbilical Cord MSCs Chinese PLA General Hospital 7 ChiCTR2000030300 China Donated Umbilical Cord MSCs Nanjing Second Hospital 8 NCT04293692 China Donated Umbilical Cord MSCs Puren Hospital Affiliated to Wuhan University of Science and Technology 9 ChiCTR2000030484 China Donated Umbilical Cord MSCs Beijing Darwin Cell Biotechnology Co., Ltd 10 ChiCTR2000030866 China Donated Umbilical Cord MSCs The First Hospital of Changsha 11 NCT04313322 Jordan Donated Umbilical Cord MSCs Stem Cells Arabia 12 ChiCTR2000031494 China Donated Umbilical Cord MSCs Huangshi Hospital of Traditional Chinese Medicine (Municipal Infectious Disease Hospital) 13 NCT04333368 France Donated Umbilical Cord MSCs Assistance Publique - Hôpitaux de Paris 14 NCT04339660 China Donated Umbilical Cord MSCs Watson Biotechnology Group Co. Ltd
Biotechnology Companies Start Stem Clinical Trials
- US FDA Approves COVID-19 Trial After Successful Emergency Use of Donated Umbilical Cord Stem Cells From RESTEM Company
RESTEM, a leading cell-based therapeutics company in USA, announced today it has received approval from the U.S. Food and Drug Administration (FDA) for a 60-patient Phase I/IIa study using donated umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19. The study will be the first of its kind in the U.S. This treatment has already shown promising results in patients in the U.S. hospitalized with COVID-19 who also had developed acute respiratory distress syndrome (ARDS). The patients, who were all on ventilators, were treated with donated umbilical cord mesenchymal stem cells under an emergency approval from FDA, and two have now been discharged from the hospital. This multicenter study is officially known as the Systemic Umbilical Cord Cells to Ease Severe Syndrome with COVID-19 (SUCCESS) trial. RESTEM's cells are grown from umbilical cord tissue by a proprietary process that allows millions of doses to be replicated rapidly. The SUCCESS trial will identify COVID-19 ARDS patients who could best benefit from ULSC and will develop randomized placebo controlled evidence about the ability of these cells to heal patients with this disease. Patients will be able to participate in the SUCCESS clinical trial both at Miami Cancer Institute and at Sanford Health.
- Athersys, Inc., USA Receives US FDA Approval To Initiate a Phase 2/3 Pivotal Study In Patients With COVID-19 Induced ARDS
Ohio, USA based biotechnology company Athersys, Inc., has initiated a Phase 2/3 clinical trial using its MultiStem® therapy against acute respiratory disease syndrome (ARDS), which is the leading cause of death in COVID-19 patients. This therapy uses a special class of stem cells to repair damage and reduce inflammation caused by the viral infection.
- Celularity Announces US FDA Clearance of Investigational New Drug (IND) Application for CYNK-001 in Coronavirus, First in Cellular Therapy
New Jersey, USA based a clinical-stage company Celularity that develops allogeneic (donor) cellular therapies from human placentas, has received US FDA clearance under IND application for the use of its proprietary ‘CYNK-001’ in adults with COVID-19. With this, Celularity will commence a Phase I/II clinical study including up to 86 patients with COVID-19. The Company believes CYNK-001 is the first immunotherapy IND cleared by the FDA to treat COVID-19 infected adults.
- Lattice Biologics, USA Starts Enrolling Patients:
Lattice Biologics, is enrolling patients for its Phase 1 clinical trial in Seattle, USA. The trial will address the safety and efficacy of its stem cell technology, ‘AmnioBoost’, which is an investigational therapy comprising concentrated allogeneic (donor) MSCs and inflammation-inhibiting cytokines for the treatment of severe acute respiratory syndrome (SARS) related to COVID-19 infection.
- Israeli Ministry of Health Clears a Path to Allow Per Patient Compassionate Use Treatment of COVID-19 Patients with Pluristem’s PLX Cells
Israel based company Pluristem Therapeutics Inc. claims to have treated its first American patient suffering from COVID-19 complications under the country’s compassionate use program. PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering a key advantage in addressing a global pandemic. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the incidence and\or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients.
- Mesoblast’s RYONCIL™ (Remestemcel-L) Receives US FDA Clearance For Treating COVID-19
Melbourne, Australia and New York-based Mesoblast Limited announced that in a study of COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS), there was 83% survival with two intravenous infusions of the company’s experimental allogeneic mesenchymal stem cell candidate Ryoncil (Remestemcel-L).
- Hope Biosciences’ MSCs Against COVID-19 Gets US FDA Approval For Phase II Trial
Hope Biosciences, a clinical stage biotechnology company from Texa, USA that is focused on developing cell-based therapeutics for acute and chronic disease, has received the US FDA approval for a Phase II clinical trial evaluating efficacy and safety of its proprietary core technology mesenchymal stem cell (HB-adMSCs) to provide immune support against COVID-19.
- Government of India, Ministry of Health & Family Welfare, Directorate General of Health Services (EMR Division). Revised Guidelines on Clinical Management of COVID-19. [Online] March 31, 2020. Accessed on April 5, 2020.
- Guidance for Management of Pregnant Women in COVID-19 Pandemic ICMR ICMR & National Institute for Research in Reproductive Health - http://www.nirrh.res.in/guidance-for-management-of-pregnant-women-in-covid-19-pandemic/
- The Federation of Obstetric and Gynaecological Societies of India. Good Clinical Practice recommendation on Pregnancy with COVID-19 Infection; Version 1; [Online] March 28, 2020. Accessed on April 5, 2020.
- Parents Guide To Cord Blood Foundation: https://parentsguidecordblood.org/en/news/coronavirus-during-pregnancy-and-cord-blood-banking
- The Royal College of Midwives, Royal College of Obstetrics and Gynaecology, Royal College of Paediatrics and Child Health, Royal College of Anaesthetists. Coronavirus COVID-19 Infection in Pregnancy; Version 5. [Online] March 28, 2020. Accessed on April 5, 2020.
- Favre G, Pomar L, Qi X, Nielsen-Saines K, Musso D, Baud D. Guidelines for pregnant women with suspected SARS-CoV-2 infection. Lancet Infectious Diseases 2020 pii: S1473-3099(20)30157-2. [Online] March 3, 2020. Accessed on April 5, 2020.
- American College of Obstetricians and Gynecologists. Novel Coronavirus 2019 (COVID-19) Practice Advisory [Online] March 13, 2020. Accessed on April 5, 2020.
- Centres for Disease Control and Prevention. Interim Considerations for Infection Prevention and Control of Coronavirus Disease 2019 (COVID-19) in Inpatient Obstetric Healthcare Settings. [Online] April 4, 2020. Accessed on April 5, 2020.
- Chawla D, et al. Perinatal-Neonatal Management of COVID-19 Infection. Indian Paediatrics 2020 pii: S097475591600154. [Online] April 1, 2020. Accessed on April 5, 2020.
- Cord Blood Association: FAQs On COVID-19 And Stem Cell Banking - https://cord.memberclicks.net/answers-to-questions-about-banking-during-the-coronavirus