Newsletter - March 2015

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Listen, Parents in India:

India family cord blood banks map

Stem cell transplantation has come of age. Over 80 diseases can now be treated with stem cell transplants, and clinical trials with stem cells are in progress to provide additional therapies in the future.

Those companies that provide stem cell banking with high quality and true ethics will only promote stem cell therapies that are based on scientific facts. Too many private cord blood banks are taking a more emotive approach, making false claims, and using eye-catching features to attract clients.

In India, accurate education is needed at all levels for all participants in the banking process. Classes should be conducted for doctors and gynaecologists in all cities and towns of the country and neighbouring nations. Regular counseling sessions should be conducted by doctors and counselors to explain the stem cell concept to pregnant patients in hospitals, clinics, and nursing homes.

The Indian Council of Medical Research (ICMR) and Drugs Controller General of India (DCGI) have set standards for all cord blood banks. Cord blood banks of good repute will not only follow these standards, but will also have a track record of experience, and will have attained global accreditation by meeting standards such as those of AABB and/or FACT.

Here is what parents who are contemplating cord blood banking should know:

Information: Parents should be given all available information regarding stem cell medicine. All queries from the public should be answered by knowledgeable experts. For those cord blood banks accredited by AABB, a technical specialist is available to answer all inquiries submitted to the Accreditation mailbox.

Collection: The cord blood collection should be performed by trained nursing or paramedical staff. This helps to ensure good volume, no clots, and no contamination. Well trained nursing staff can improve the size of the collection, and the simple fact is that more volume means more stem cells.

Materials Used: Collection bags, cryogenic storage bags, chemicals used in processing, etc. must all be from reputed suppliers to ensure global quality standards. The accreditation organization AABB requires that materials used in processing should either be approved for human use by the Food and Drug Administration (FDA) of the United States, or by the relevant competent authority when possible, or should have medical literature to support their use.

Transportation of Collection Kits: After the cord blood is collected, government regulations require that it must be transported to the laboratory within 72 hours, while maintaining temperature in the transport kit below 25 degrees Celsius.

Processing and Storage: The technology used to reduce the blood volume and/or separate stem cells should be up to the quality of international standards so as to maximize stem cell yield and minimize microbial contamination.

Storage Location: A bank may choose to store the final stem cells in two portions of a bag or in two locations, to give parents peace of mind about natural or manmade calamities. Nowhere do the standards of the US FDA or India DCGI say that dual storage is not permitted. For each sample stored, the entire laboratory process has to be validated to ensure that the final product meets release specifications for viability and potency of the stem cells.

Transplant Experience: A reputed cord blood bank will have a fair number of retrievals for transplants. Cord blood samples that are released for clinical trials in countries abroad must meet the requirements for import into those countries. A bank that offers public cord blood banking must meet the international registry requirements for stem cell therapies from an unrelated donor.

This summary of important points will allow parents to take a well-informed decision, in absence of any false, misleading attractions.

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Globe's 2 Largest Cord Blood Banks Partner

Todd Van Horn, MBA

Todd Van Horn, MBA, Vice President, Business Development at Cord Blood Registry

Cord Blood Registry® (CBR®), the world's largest newborn stem cell company, and China Cord Blood Corporation (CCBC), the first and largest cord blood bank in the world's most populous country, have entered into a strategic partnership agreement for research collaboration.

Recognizing the critical need to accelerate biomedical innovation and patient access to important technologies, the two prominent cord blood banks will share data on cord blood collection and preservation. The organizations will also work together to develop a family disease registry for CCBC's clients in China and jointly support newborn stem cell-related clinical trials in the United States and China.

This important collaborative effort achieves a milestone in bringing the two largest cord blood banks in the world into close concert for the benefit of their client families, future patients and the stem cell clinical research community.

Additionally, the CBR-CCBC partnership presents an opportunity to aid families impacted by certain diseases across an international and racially diverse population. In the aggregate, CBR and CCBC have collected and stored samples from an estimated 1 million newborn children worldwide, accounting for nearly one quarter* of all cord blood units preserved globally.

Kam Yuen, Chairman of CCBC commented, "This memorandum brings together two cord blood banks that collectively serve approximately 1 million clients and represents the most significant joint effort to date in the global cord blood banking industry. Through this collaboration, we hope to create new possibilities to service clients and patients, and provide greater support to the stem cell clinical research communities in both China and the United States."

"CBR and CCBC are both committed to bringing forward clinical applications of newborn stem cells for a host of conditions that could benefit from regenerative medicine," said Geoffrey Crouse, President and Chief Executive Officer of CBR. "Through this collaboration, we will be able to share our expertise and resources and improve mutual access to crucial research in China and the United States. This first of its kind partnership is a significant step toward raising global awareness of the importance of cord blood stem cell research."

Todd Van Horn oversees all CBR business development activities, including strategic partnerships, and collaborations. Additionally, Mr. Van Horn is responsible for CBR's business intelligence team, supporting and guiding CBR's commercial strategy and tactics.

*Reference: Parent's Guide to Cord Blood Foundation's confidential survey finds that the world inventory of cord blood in family banks is over 4 million as of the end of 2014.

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World's 1st Trial of Amnion Stem Cells for Premature Babies

Rebecca Lim, PhD

Rebecca Lim, PhD, Head of Amnion Cell Biology Research Group at The Ritchie Centre, Australia

The medical potential that lies in cord blood is clear and the cord blood banking industry is booming, but have you ever considered the remaining perinatal tissues that are routinely discarded as medical waste?

Walking through the aisles of some pharmacies or healthcare stores, you will find capsules of sheep placenta being sold as health supplements, "placental hair masks" and other such things. There are now international services that offer dehydration and encapsulation of your baby's placenta, even placenta cookbooks! A more realistic service is offered by a few cord blood banks that preserve the stem cells from placental blood and placental tissue.

Additional perinatal tissues also have value. The fetal membranes - amnion and chorion - also contain stem cells and stem cell-like cells that can be isolated and banked for clinical use. The amnion and chorion ("amnion" hereafter) form a membrane that surrounds the baby during pregnancy and plays an important role in protecting the baby from physical and immunological damage. (Motifolio credit for diagram below)

       Fetus at the end of the 3rd month showing the fused amnion and chorion laeve

The amniotic membrane has unique wound healing properties and has been used as a wound dressing for decades. This is because the amnion has potent anti-inflammatory, pro-regenerative and scar-reducing properties. In fact, a number of randomised clinical trials favour the use of amnions in burns for their promotion of wound healing, patient comfort, and reduced need for dressing changes. The amnion dressings promote cell growth, modulate inflammation and recruit endogenous (local) stem cells to facilitate wound repair.

Perinatal stem cells and maternal tolerance

Research has provided insights into the complexity of the interaction between the mother's and baby's separate immune systems; this interaction takes place at the maternal-fetal interface and is necessary for a healthy pregnancy. One of the key changes in the immune system of an expectant mum is the switch from immune surveillance to immune tolerance. In healthy full-term pregnancies, this switch prevents the rejection of the fetus, which is essentially foreign to the mother's immune system.

The switch in a mother's immune system during pregnancy is largely mediated by regulatory T cells in the maternal bloodstream. We now know that some of the stem cells and stem-like cells of the placenta and fetal membranes have a vital role to play in this immunological switch. They are responsible for triggering cellular events such as activating the maternal regulatory T cells that maintain tolerance and promoting their proliferation, while concurrently inducing the death of activated T cells that could compromise the pregnancy.

Bankable cell types from perinatal tissues

Mesenchymal Stem Cells (MSCs) have been successfully isolated from first-, second-, and third-trimester placental compartments, including the amnion, chorion, decidua parietalis and decidua basalis. The MSCs represent less than 1% of the cells present in the placenta, while the average yield of MSCs from chorions and amnions is between 1 to 10 million per gram of tissue. Regardless of their source, MSCs have potent immunosuppressive properties and MSCs obtained from the fetal membranes are no exception. Chorionic and amniotic MSCs suppress T cell proliferation to the same extent as bone marrow derived MSCs.

Amnion Epithelial Cells (AECs) are a stem-like cell that can be isolated in large numbers (150 to 200 million per gram) from full-term placentae. Here are their technical properties: AECs have multipotent differentiation potential and expression of pluripotent stem cell specific transcription factors including Oct4 and Nanog. Unlike MSCs, which are all plastic adherent, primary AECs have three subpopulations of cells that are adherent, loosely adherent, and free-floating. Of these subpopulations, the adherent AECs have the lowest expression of Oct4 and Nanog. Notably, most in vivo studies to date have used the entire AEC fraction rather than a specific subpopulation of AECs.

AECs share many immunosuppressive properties with MSCs. They both release prostaglandins that mediate inflammatory response and regulate tissue repair. AECs also release HLA-G, a histocompatibility leukocyte antigen that can aid with tissue repair. The HLA-G molecule plays a major role in immune tolerance during pregnancy, particularly at the maternal-fetal interface, where HLA-G inhibits the migration and proliferation of maternal immune cells.

The future of perinatal stem cells

In summary, the placenta and other perinatal tissues are a rich source of stem cells and stem-like cells, which can potentially be banked in a similar manner to cord blood. Rather than banking only the cord blood and discarding the rest of the perinatal tissues, it is time we started routinely banking all of the perinatal tissues and the vast stores of stem cells and stem-like cells that they contain.

Researchers are working towards the translation of perinatal stem cells from the laboratory bench to the patient bedside. Both MSCs and AECs from perinatal tissues have been shown to exert potent immunomodulatory and pro-regenerative effects in animal models of bronchopulmonary dysplasia (BPD), a major health risk for severely premature infants. At the Ritchie Centre of Monash University in Australia, we are running the world's first clinical trial to assess the safety of amnion epithelial cells in premature babies with established BPD.

Rebecca Lim received her PhD from the University of Western Australia where she investigated the role of endogenous adult stem cells in the liver during repair and injury. She now heads the Amnion Cell Biology Research Group at The Ritchie Centre and holds a joint appointment with the Department of Obstetrics and Gynaecology at Monash University. Her current work is focused on understanding how amnion epithelial cells exert their beneficial effects to promote repair across a wide range of disease models. Dr. Lim is particularly interested in how the amnion epithelial cells trigger key immunological switches needed for tolerance and immune modulation.