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Wait a Minute: The Ethics of Cord Blood Collection

Delayed umbilical cord clamping has a variety of benefits for newborns and is the current standard of care at the time of delivery.

Does your cord blood collection agency adhere to these medical and ethical standards? Read on to learn more.

In the past 10 years, the cell therapy industry has developed drugs that treat inherited blindness, have cured certain forms of blood cancer, and have sent diseases such as HIV into remission. These milestones have encouraged large amounts of investment in and development of the industry, spawning biotechnology companies and accelerating traditional, large pharmaceutical companies moving into the field.

Cell therapies are made through a manufacturing process that relies on raw materials that are procured from industry suppliers. Umbilical cord blood is one such raw material source that has grown in popularity because it is an easily accessible source for hematopoietic stem/progenitor cells (HSCs) and immune cells, which can be used in transplantation and in the development of cell-based immunotherapies (read more here). Researchers rely on the procurement of cord blood for the advancement of their studies and often require large amounts of this potent source material.  There is a direct, proportional relationship between the volume of blood in a cord blood unit (CBU) and the number of HSCs and immune cells that can be isolated from the blood. Thus, the natural inclination is to collect as much cord blood volume as possible from the cord tissue. This, however, poses a potential ethical issue for the physician and the cord blood collection agency.

The collector of cord blood – usually an OB/GYN – needs to strike a balance between how much blood flows to the newborn versus how much is collected. The American College of Gynecology and Obstetrics (ACOG) provides guidance on how to strike this balance through a process called “delayed umbilical cord clamping.”1 ACOG recommends a delay in umbilical cord clamping in vigorous term and preterm infants of at least 30–60 seconds after birth.1 The volume of blood collected is determined by two main variables: (i) the donor’s profile (e.g. age, weight, etc.), which determines the total amount of cord blood in the umbilical cord, and (ii) the method of collection, which determines how much cord blood flows to the newborn baby versus into a collection bag.2

Full term infant blood volume distribution is about 1/3 in the placenta and 2/3 in the fetus. While initial breaths taken by the newborn allow for 90% of blood in the placenta/cord tissue to transfer to the newborn, delayed clamping of the cord by at least 30 seconds, allowing for more blood return to the newborn, has been shown to improve neonatal outcomes.2-4 This practice allows extra iron, antioxidants, stem cells, and antibodies to flow from the placenta into the baby. In 15 clinical trials including 3,911 women and their babies, early cord clamping – defined as clamping less than 1 minute after birth – resulted in significantly lower concentration of hemoglobin at birth, as well as increased likelihood of iron deficiency at 3-6 months of age, compared to outcomes with delayed cord clamping (DCC) – defined as clamping more than 1 minute after birth or when cord pulsation stops.1,4,5 Although jaundice requiring phototherapy was slightly increased in infants with delayed cord clamping, the effectiveness of jaundice management regimens  has led the medical community to determine that the benefits of DCC outweigh the risks.3-5

Earlier studies focused on preterm or intra-uterine growth restriction babies concluded that DCC resulted in increased stem cell transfusion, lower incidence of anemia requiring transfusion, and significantly less intraventricular hemorrhage and necrotizing enterocolitis (a serious disease that affects the intestines) in newborns.3,5 There was no significant difference in the need for phototherapy treatment for jaundice with or without DCC. When it comes to maternal outcomes, studies conclude that DCC is not associated with postpartum hemorrhage or blood loss at delivery. In addition, there is no increased need for blood transfusion or low postpartum hemoglobin level. 3-5

Given the obvious benefits to the newborn and no significant risk for the mother, many professional organizations are now in agreement when it comes to DCC recommendations (see chart below). The recommended times of DCC vary depending on gestational age, position of the newborn in relation to the placenta, signs of vigor, respiratory function of the newborn at the time of birth, and risk for maternal hemorrhage. Physicians must use their judgment to determine the duration of DCC based on these metrics.

As a result of DCC, cord blood collection volumes can vary greatly, from as little as 30mL to 100mL.3 Variation is due to a number of factors including newborn age, weight of the infant, placenta size, umbilical cord length, and/or timing of DCC. However, the average cord blood unit volume has decreased significantly following the implementation of DCC guidelines, and CBUs over 100 mL are now very rare if physicians adhere to these guidelines during birth. Thus, DCC results in significantly lower cord blood volume and cell count, which in turn leads to cord blood units which may be unsuitable for transplantation or the isolation of cells of interest. This, in turn, may lead some birth tissue collection organizations to encourage non-adherence to ACOG and other guidelines for DCC.

OrganaBio collects birth tissues (including cord blood) through its wholly owned, FDA-registered subsidiary, GaiaGift.  Tissues are collected from consented, non-compensated donors, under IRB approved protocols, to provide researchers with high quality cellular raw materials for the advancement of cutting-edge cell therapies. The OrganaBio team works closely with physicians to educate medical professionals and donors about perinatal tissue donation and the ethical and medical implications of the collection process. OrganaBio has an unwavering commitment to the ethical collection of tissues, putting the health and well-being of moms and newborns at the forefront of operations, and OrganaBio physicians strictly adhere to DCC guidelines, despite lower cord blood volume yields. 

It is imperative upon the scientific community to find the balance between benefits to the infant and the volume of cord blood collection. Ultimately, a collection procedure that does not strictly adhere to medical guidelines may put an entire cell therapy program at risk. As such, OrganaBio works with our scientific partners to explore next-generation tools and technologies to optimize cell yield from cord blood units collected to meet the highest medical and ethical standards.

References

  1. American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice. Delayed Umbilical Cord Clamping After Birth: ACOG Committee Opinion, Number 814. Obstet Gynecol. 2020 Dec;136(6):e100-e106
  2. Bruckner M, Katheria AC, Schmölzer GM. Delayed cord clamping in healthy term infants: More harm or good? Semin Fetal Neonatal Med. 2021 Apr;26(2):101221.
  3. DuPont, T. L., & Ohls, R. K. (2018). Placental Transfusion: Current Practices and Future Directions. NeoReviews, 19(1), e1–e10.
  4. Gomersall J, Berber S, Middleton P, et al. Umbilical Cord Management at Term and Late Preterm Birth: A Meta-analysis. Pediatrics. 2021;147(3):e202001540
  5. Surak A, Elsayed Y. Delayed cord clamping: Time for physiologic implementation. J Neonatal Perinatal Med. 2022;15(1):19-27.

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Andrew Larson

Managing Director, CPC Services

Andrew joins OrganaBio as a project manager with varied experience in project management, client relations, and process improvement.

Prior to OrganaBio, Andrew was a client relations manager for the cGMP nucleic acids business unit at Aldevron, coordinating and managing contracts at each stage of the contract lifecycle in support of cell and gene therapy program development. Andrew supported small- and large-scale biotechnology and pharmaceutical clients anywhere from pre-IND work through commercial supply chain establishment. Before Aldevron, Andrew was a project manager for the commercialization and business development department for Sanford Health, a worldwide hospital institution. At Sanford Health, Andrew helped manage medical device patent and prototype development efforts for employee innovations primarily in the cardiovascular, neurovascular, and software spaces. Andrew was also an engineer for Atirix Medical Systems and supported the buildout of automated analysis worksheets to streamline radiology department quality control procedures.

Andrew received his Bachelor of Science in Physics from Minnesota State University Moorhead and his Master of Science in Biomedical Engineering from the University of Minnesota. At the University of Minnesota, Andrew was part of the Center for Magnetic Resonance Research, assisting efforts to automate MRI dataset registration and workflow improvement.

Michael Dee

Associate Director, QC and Analytical Development

Michael Dee has spent the last 17 years researching the immune system. Initially studying the recombinant cytokine IL-2 and its role in T cell subset differentiation and function at the University of Miami. He also helped elucidate the lower level of TCR diversity of T regs required to prevent autoimmunity in mice. Michael also supported construction, cloning, production, purification, and testing both in vitro and in vivo a novel IL-2/IL2Rα complex currently under clinical development with BMS. Michael also was a member of the department of immunology’s program project delineating the effect of a novel Eg7GP96 heat shock protein vaccine on tumor immunity.

While at Immunity Bio (formerly Altor Biosciences), he helped to characterize over 20 novel drugs for immune modulation and treatment of cancer.  After Immunity Bio, Michael was a founding team member of HCW Biologics, where he continued his role in design and initial production and characterization of several novel biologics. He has experience with proof of principle experiments with the generation CAR-NK and CAR T cells. His research at HCW was highlighted by his discovery of a process using novel biologics to activate and expand CIML NK cells. The process and rights were sold to Wugen and is currently in Phase I clinical trials. He also is listed as an Inventor on patent number: US20210268022A1 on method of activating regulatory T cells.

Meram Alamoudi

Senior Cell Processing Specialist

Meram received her master’s degree in biomedical sciences from Barry University and bachelor’s in Biology from Palm Beach Atlantic University.

Before her position at OrganaBio, Meram conducted research at Larkin University where she worked on assessing the impact of Hurricane Maria on respiratory diseases in Puerto Rico, which provided her with insight into research investigation and analysis along with generation of grant documentation.

Valeria Beckhoff-Ferrero

Senior Bioprocess Scientist

Valeria Beckhoff Ferrero has over 5 years of experience in the fields of stem cell research and tissue engineering. Valeria received her Bachelor of Science in Biomedical Engineering, specializing in Biomaterials and Tissue Engineering, from Drexel University in Philadelphia. Valeria has expertise in problem solving and finding manufacturing solutions for isolating various types stem cells and other cell derived products from different tissues.

Before joining OrganaBio, Valeria was a lead manufacturing engineer at the Amnion Foundation. She aided in instituting a GMP infrastructure, including documentation, to manufacture clinical grade placental derived stem cells. In her role, she worked in perfecting isolation, culture, selection and cell maintenance processes for perinatal derived stem cells.

Valeria’s experience includes working as an Automation Engineer at the New York Stem Cell Foundation, where she aided in the creation and coding procedures for liquid handlers to manufacture induced pluripotent stem cells. At NYSF, Valeria researched new methods of sorting, reprogramming and differentiating iPSCs.

During her studies, Valeria worked at Thomas Jefferson University Hospital’s Radiation Oncology department, where she engineered various devices to aid in hyperthermia treatments. Additionally, Valeria co-authored multiple publications on magnetic resonance guided focused ultrasound and radiation antennas for hyperthermia treatments.

Marisa Reinoso

Director, Regional Scientific Sales

Marisa has experience leading marketing and sales life sciences programs for over a decade. Originally a lab researcher, she made the jump to marketing & sales in life sciences and never looked back.

At OrganaBio, she connects cell therapy developers on the West coast and in Asia with the healthy donor starting materials they need to develop their therapies. Prior to OrganaBio, she was the cell therapy marketing lead at Invetech, heading the launch of the company’s first cell therapy product. Marisa has led marketing programs at clinical supply companies Sherpa Clinical Packaging and PCI Pharma Services. In her spare time, Marisa enjoys traveling, eating, and pretending she’s a tennis player. She has a Bachelor of Arts in Biology from Reed College and an MBA from Portland State University.

Thelma Cela

Senior Director, Tissue Procurement

Thelma Cela is a top performing professional with over 25 years’ experience in management, leadership, business development and marketing fields with business acumen and skills in driving revenue and profit growth in multiple corporate cultures. Prior to joining OrganaBio, Thelma served as Senior Director for Health and Human Services for the Seminole Tribe of Florida. Her role had oversight for health clinics, health plan administration, the behavioral health department, and elder services. In this governmental administrative capacity, Thelma had primarily responsibility for the HHS’ divisions’ budget, capital projects, utilization management, efficiency, and efficacy.

Thelma’s prior work experiences include Vice President of Clinical Operations for OrthoNOW. In this role, she provided guidance on all clinical matters, set direction on clinical policies and procedures and monitoring healthcare policy changes. As the national Vice President of Clinical Operations, Thelma also designed, developed, and implemented guidelines and protocols and ensured compliance regarding overall patient experience.

Before joining OrthoNOW, Thelma had been recruited by Leon Medical Centers, a private healthcare company operating comprehensive medical centers to launch a new business line addressing the health and wellness of an aging population. As Director, Thelma researched, created, and launched the company’s Health Living Centers which provided first of its kind facilities in the South Florida market to offer services to the community of health aging.

Thelma has a proven track record in multiple corporate healthcare cultures having worked for Mercy Hospital where she was Senior Program Director of their Diabetes Treatment Center and Director of their Surgical Weight Loss Program. She enhanced these service lines awareness in the community, improved both lines’ clinical outcomes, and built volume growth while maintaining ongoing physician support. She served in a similar capacity for American Healthways.

Thelma earned her MBA from Miami Regional University where she graduated Cum Laude and her undergraduate degree in Psychology is from the University of Miami.

She serves on the advisory panel for Florida International University’s Women in Business Leadership Program helping future women become future business leaders through thought leadership, barrier destruction, and the power of influence.

Dominic Mancini

Vice President, Operations

Dominic Mancini brings 12 years of experience working the interfaces between Analytical Development, Process Development, Quality, and Manufacturing Science to OrganaBio. A lifelong learner, Dominic enjoys solving the many scientific and operational challenges presented in the field of cell and gene therapy.

Prior to OrganaBio, Dominic spent 8 years at Bluebird Bio as the company grew from 45 to 1200+ employees and from 1 clinical asset to a robust commercial pipeline. At Bluebird, Dominic initially supported the development and technology transfer of lentiviral vector manufacturing processes. As demand grew for lentiviral process and product characterization, Dominic led the development, qualification, transfer, and validation two commercial release methods. Dominic transitioned back to the Process Development organization to lead the vector manufacturing core team, increasing operational efficiency through a 5S implementation, process schedule intensification, and reverse technology transfer initiative. More recently, Dominic supported the build-out of bluebird’s Manufacturing Science & Technology team followed by the Data Systems & Analytics team, handling late-stage commercial asset support.

Dominic received his Bachelor of Chemical Engineering with Distinction from the University of Delaware. Dominic’s undergraduate research culminated in his thesis on heterologous expression of G-protein coupled receptors in Saccharomyces cerevisiae. After graduation, Dominic was the premier hire of the Zhou Laboratory at Brigham and Women’s hospital in Boston, MA. In three years, Dominic established an animal model of COPD and co-authored several papers with his collaborators in the Pulmonary division.

Christopher B. Goodman

Vice President, Quality & Regulatory Affairs

Christopher B. Goodman is a biopharmaceutical consultant and executive making a global impact in the cellular therapy technology arena. The scope of Christopher’s expertise encompasses Cellular Therapeutic Operations, Quality and Regulatory Affairs, Global Corporate Operations, Scientific Strategic Planning, Scientific R&D Collaborations, and Marketing & Commercialization.

Christopher recently joined OrganaBio as their Vice President of Regulatory Affairs. In this role, Christopher will be helping the company, its clients and partners navigate the complexities of the domestic and international regulatory requirements governing advanced cellular therapy products and manufacturing.

Previously, Christopher held positions with the Association for the Advancement of Blood and Biotherapies (AABB), Virgin Health Bank, Ventana Medical Systems, and Celgene.

While with AABB, he held the positions of Senior Director of New Products and Lead Quality Assessor, auditing both domestic and international organizations to known standards in an effort to promote and ensure patient quality care and manufactured product consistency and standardization within Cellular Therapy, Blood Banking, Transfusion Services, Perioperative and Donor Center industries and operations. He contributed greatly to the work of AABB’s accreditation program providing his deep breadth of knowledge and technical acumen on many committees during his tenure. His pioneering work in the realm of virtual assessments during the COVID pandemic allowed AABB to flex into the planning and execution of this novel approach to the maintenance of accreditation activities during a global travel crisis. His agile thinking and approach to planning provided as minimal disruption as possible to AABB’s customer facilities.

While working with Virgin Health Bank in the State of Qatar and the United Kingdom, Christopher advanced through a series of executive roles. He joined Virgin Health Bank as the Director of Operations, during which time he managed the successful design, and build out of a new state-of-the-art cGMP facility, the first in the Middle East. As Director and Chief Executive Officer, he directed the launch of the first Arab-centric stem cell bank, and strategically guided the organization to enhanced shareholder value and expansion across the Middle East and UK. In these roles, he also oversaw global corporate operations, research collaborations, product portfolio expansion, and regulatory framework.

Christopher managed the Detection and Chemistry Assay Development Group for Ventana Medical Systems, a global leader and innovator of tissue-based diagnostic solutions. In this role, he directed overall program goals, optimized resources, and guided technical and product direction in global regulated environments.

Prior to Ventana Medical Systems, he held the position of Director of Operations for the high-growth Cellular Therapeutics Division of Celgene. As a senior-level scientist and member of the executive team, he directed divisional operations, medical affairs and executed business and scientific strategic planning.

Danielle Smyla

Senior Director, Quality Assurance

Danielle Smyla, M.S., brings 14 years of Quality Assurance and GMP experience in the Biotechnology and Medical Device industries. Ms. Smyla is an established Quality Leader with expertise in the implementation, management and continuous improvement of Quality Management Systems for GMP operations.

Prior to joining OrganaBio, Danielle was a key member of the Quality Management team at Canon BioMedical, where she led the cross-functional development and implementation of their Quality Management System. She also managed a team of Quality Specialists and Sr. Specialists, coaching them in the implementation, management and identification of improvements to quality processes.

Ms. Smyla’s Quality-focused career is complimented by valuable hands-on experience in GMP product manufacturing, as well as R&D laboratory experimentation and formulation work in support of product development.

Danielle has earned a Master’s in Biotechnology from the Johns Hopkins University and a Bachelor of Science in Chemistry from the George Washington University.

Priya Baraniak, Ph.D.

Chief Business Officer

Dr. Baraniak is a proven strategic thinker, problem solver and leader who brings 20 years of expertise in stem cells and tissue engineering, coupled with a keen business acumen, to OrganaBio. Dr. Baraniak has published multiple peer-reviewed papers and book chapters on the use of stem cells and biomaterials in cardiac repair and regeneration and is routinely invited to speak at conferences.

Before joining OrganaBio, Priya was a founding member of RoosterBio and was a vital member of the company’s Leadership Team. At RoosterBio, Priya leveraged her technical expertise to build and rapidly scale the company’s sales and marketing engines in a fast-paced start-up environment, delivering impressive growth in revenue year-over-year. Additionally, in her role as Business Development lead at RoosterBio, Priya structured, negotiated and executed multiple strategic partnerships for aggressive growth of the organization.

Priya’s industry experience includes a role as Senior Director of R&D for Garnet BioTherapeutics, a clinical-stage stem cell-based regenerative medicine company, where Priya led multiple projects on tissue repair and regeneration using mesenchymal stem cell (MSC)-based therapeutics and devices. While at Garnet Bio, Priya also worked on the company’s FDA filings, contributed to drafting and prosecuting the company’s patent portfolio, managed CRO, CMO and industry partner relationships and actively participated in establishing Garnet’s strategic R&D plan, thereby gaining critical insights into business operations across a small organization.

Priya’s scientific training began as an undergraduate student at Duke University, where she earned a Bachelor of Science in Engineering (BSE) from Duke University in 2001 after double majoring in Electrical Engineering and Biomedical Engineering. While at Duke, Priya conducted research in the lab of Dr. Doris A. Taylor on the use of skeletal myoblasts and stem cells for cardiac repair and regeneration. Priya went on to receive her Ph.D. in Bioengineering from the University of Pittsburgh in 2008. She completed her dissertation research in the laboratory of Dr. William R. Wagner working on developing a controlled release biodegradable elastomer for applications in cardiovascular regenerative medicine. In 2008, Priya joined Dr. Todd McDevitt’s lab in the Department of Biomedical Engineering at Georgia Tech and Emory University as a post-doctoral fellow. Her post-doctoral research as an American Heart Association Fellow focused on harnessing the secretome and isolating the extracellular matrix from MSCs and other cell types, including pluripotent stem cells, for cardiac tissue repair and regeneration. Priya co-authored many grants while a post-doc and went on to contribute critical sections to a NIST grant that resulted in the first ever National Cell Manufacturing Consortium in the United States.

Sarah Alter, Ph.D.

Senior Director, Scientific Affairs

Sarah Alter, Ph.D., has 15 years of immunology research experience which includes autoimmunity, cancer, and infectious disease.

Before her position at OrganaBio, Sarah was responsible for leading a team of scientists at Altor Bioscience where she facilitated the advancement of Altor’s technologies. As a Research and Development Manager, Dr. Alter coordinated immunotherapy-focused preclinical and clinical studies and contributed to the progress of Altor’s drug discovery and therapeutic applications.

Sarah received her Doctor of Philosophy from the University of Miami, Miller School of Medicine. She is also a registered Patent Agent, licensed to practice before the United States Patent and Trademark Office. Her work was published in many peer-reviewed journals and presented at national and international business and scientific meetings.

Carlos Carballosa, Ph.D

Director, Scientific Sales

Carlos Carballosa is a biomedical engineer with over 8 years of stem cell research experience with broad expertise in the culture, differentiation, and cryopreservation of adult stem cell populations. Carlos earned his bachelors, masters and doctorate degrees in Biomedical Engineering from the University of Miami, where his research focused on the effects of nicotine and electronic cigarette vapor exposure on the regeneration potential of adult stem cells. In addition to his dissertations, Dr. Carballosa has authored numerous publications related to stem cell biology.

Oscar Robles

Director, Quality Systems

Oscar Robles has over thirty years of experience in pharmaceutical and medical device industries. His main areas of expertise are in Quality Systems, Quality Assurance, Manufacturing Systems Validation, Computerized Systems Validation, implementation of GxP Computerized Systems and ERP Systems such as TrackWise, Electronic Document Management, JDEwards, SAP, and Oracle. Prior to joining OrganaBio, Oscar was a member of the Quality Management team at Apotex – Aveva Drug Delivery Systems for ten years. Oscar has earned a Master’s in Business Administration from Nova Southeastern University and a Bachelor of Science in Electrical Engineering from Florida International University.