This page contains exclusive content for the member of the following sections: TTS, CTS, IPITA, ISODP, IXA, ITA, TID, IHCTAS, IPTA, SPLIT, ISUTX. Log in to view.
Reproductive Bioengineering
0.0 - Reproductive Bioengineering: From Fertility Therapies to Digital Pregnancy
Presenter: Christian Kramme, Kristin Myers, , , Unites States Authors: Christian Kramme, Kristin Myers, David Lott, Rohan Paul, Alice Tomei
Overview
Dr. Kramme will discuss Advancements in the use of human induced pluripotent stem cell-derived therapies for infertility treatment: Fertilo In Vitro Maturation.
Dr. Kramme will present an overview of the ideation, preclinical development, and clinical translation of Fertilo, an iPSC-derived ovarian support cell therapy for in vitro fertilization treatment. The presentation will cover the stem cell engineering, pivotal animal model studies, and first in human studies of the treatment that led to the clearance of the Investigational New Drug Application with the US FDA and onset of the pivotal Phase 3 Trial. The presentation will end with a discussion of the ongoing Phase 3 trial, future directions of research, and next step for the field of cell-based products.
Dr. Myers will discuss Digital Twins of Pregnancy: A New Approach to Predicting Preterm Birth
A healthy pregnancy depends on a remarkable balancing act inside the body. The uterus and fetal membranes must stretch to make room for the growing baby, while the cervix acts like a gate, staying firmly closed to keep the baby safe. Throughout pregnancy, the cervix progressively softens, preparing it to open at the right time for delivery. When this process doesn't unfold as it should, it can lead to preterm birth, one of the most common and consequential problems in pregnancy, with lasting effects on families' emotional wellbeing and finances. In this talk, I will share how our team is using engineering tools, more commonly applied to bridges and airplanes, to build personalized computer models, or "digital twins," of individual pregnancies. These models combine ultrasound imaging with measurements of cervical stiffness, taken using a new handheld clinical device, to capture what is physically happening inside the body during pregnancy. By comparing these models across patients considered low- and high-risk for preterm birth, we are working to identify the physical warning signs that current tools often miss. My hope is that this work will lead to better, earlier ways to predict which pregnancies are at risk and to develop new tools that help clinicians act sooner to protect both mother and baby.
Learning Objectives
Translation and development of induced pluripotent stem cell derived therapies for clinical use as biologics including manufacturing, toxicology, and clinical studies. (Dr. Kramme)
The field of in vitro fertilization and in vitro maturation including challenges, unique opportunities, and patient impact. (Dr. Kramme)
Future directions of ex vivo and in vivo iPSC-derived cell therapies for use in women's health and infertility. (Dr. Kramme)
Describe the biomechanical changes that occur in the uterus, cervix, and fetal membranes during a healthy pregnancy, including how progressive cervical softening prepares the body for delivery. (Dr. Myers)
Explain how computational "digital twin" models integrate ultrasound imaging and cervical stiffness measurements to characterize the mechanical environment of individual pregnancies. (Dr. Myers)
Identify how comparing biomechanical profiles between low- and high-risk patients may help clinicians recognize early physical warning signs of preterm birth and inform future risk-prediction tools. (Dr. Myers)
Miami Engineering Career Development
Associate Professor,
Department of Biomedical Engineering
University of Miami
Dr. Tomei is the Miami Engineering Career Development Associate Professor in Biomedical Engineering at the University of Miami. She obtained her M.S. in Materials Engineering from the Politecnico of Milan (Italy) in 2004, and her Ph.D. in Bioengineering and Biotechnology from the Ecole Polytechnique Fédérale de Lausanne (EPFL, Switzerland) in 2008. Dr. Tomei currently directs the Islet Immunoengineering Lab at the Diabetes Research Institute (DRI) where she is applying her unique background in bioengineering and immunology to develop novel immunoengineering platforms to prevent rejection after islet transplantation and to promote antigen-specific tolerance for a cure of type-1 diabetes.
Professor of Otolaryngology, Mayo Clinic College of Medicine and Science
Chair, Department of Otolaryngology – Head and Neck Surgery/Audiology
Mayo Clinic, Phoenix, USA
Dr. David G. Lott holds the academic rank of Professor of Otolaryngology at Mayo Clinic College of Medicine and Science. He serves as the Chair of the Department of Otolaryngology – Head and Neck Surgery/Audiology at Mayo Clinic Arizona. His practice includes voice and swallowing restoration, laryngeal cancer, and laryngotracheal reconstruction.
Dr. Lott received his M.D. degree at the University of Iowa Carver College of Medicine and completed a residency in Otolaryngology/Head and Neck Surgery at the Cleveland Clinic Head and Neck Institute. He received further fellowship training in Laryngeal Surgery and Professional Voice at Harvard Medical School/Massachusetts General Hospital.
Dr. Lott served as the Associate Director of the Mayo Clinic Center for Regenerative Biotherapeutics for 8 years. He is faculty for both the Clinical & Translational Science and Regenerative Sciences tracks within the Mayo Clinic Graduate School of Biomedical Sciences.
In addition, he is the Director of the Head and Neck Regenerative Medicine and Transplantation Program at Mayo Clinic. The primary goal of the program is to establish safe and effective clinical translation of regenerative medicine and transplantation technologies. The team is pioneering tissue-engineered technologies to create patient-specific 3D bioprinted implants for the larynx and trachea. Additionally, the efforts of this program have resulted in the world’s first total larynx transplant in the setting of active cancer.
Throughout his career Dr. Lott has received many awards and honors, including being named in the Top Voice Doctors in America by Billboard Magazine. He received the Mayo Clinic Transform the Practice Award and has been honored with the Mayo Clinic Teacher of the Year Award. Most notably, he is a Mayo Clinic Distinguished Clinician, the highest honor given for clinical excellence.
Dr. Lott is involved with both national and international organizations and is an active member of the American Academy of Otolaryngology/Head and Neck Surgery, Triological Society, American Bronchoesophageal Society, American Laryngological Society, and the International Bronchoesophagological Society.
Associate Professor of Medicine, Washington University
St Louis, MO, United States
Rohan Paul, MD, is a transplant nephrologist and Associate Professor of Medicine at Washington University School of Medicine. His research applies single-cell and spatial transcriptomics to delayed graft function, kidney allograft injury, tubular stress responses, immune–epithelial interactions, and kidney–lung crosstalk. His work spans human transplantation and experimental kidney injury and has been presented at ASN Kidney Week and the American Transplant Congress. He also leads patient-safety and quality-improvement initiatives supported by the American Association of Kidney Patients.
Chief Scientific Officer,
Gameto Inc.
New York, United States
Christian Kramme is the Chief Scientific Officer of Gameto Inc., a biotechnology company developing fertility and endocrine therapeutics for women’s health. At Gameto, Christian invented and further developed the in vitro maturation (IVM) product Fertilo, which is currently in Phase III clinical trials in the United States. Beyond fertility, Christian and his team at Gameto likewise have invented a cell-based hormone replacement therapy for menopause and new vaginal ring deliveries for women’s health therapeutics which are in preclinical development.
Professor of Mechanical Engineering
Columbia University, New York, United States
Kristin M. Myers, Ph.D., is a Professor of Mechanical Engineering at Columbia University, where she runs a soft tissue biomechanics laboratory at Columbia University Irving Medical Center in collaboration with the Department of Obstetrics and Gynecology. An international leader in Women's Health Engineering, she uses experimental, theoretical, and computational biomechanics to study pregnancy and postpartum physiology, aiming to uncover the structural antecedents of preterm birth and develop new diagnostic and therapeutic tools. Her lab holds the largest published library of biomechanical data on human pregnancy and is among only a few worldwide building computational digital twins of pregnancy to reveal how the cervix remodels from a protective barrier into a passageway for delivery. Dr. Myers earned her doctorate and master's in Mechanical Engineering from MIT and her bachelor's from the University of Michigan. Her honors include the ASME Y.C. Fung Young Investigators Award (2017), the Presidential Early Career Award (PECASE) (2019), and induction into the AIMBE College of Fellows (2025).
Important
Disclaimer
By viewing the material on this site you understand and
accept that:
The opinions and statements expressed on this site reflect the
views of the author or authors and do not necessarily reflect those of
The Transplantation Society and/or its Sections.
The hosting of material on The Transplantation Society site does
not signify endorsement of this material by The Transplantation Society
and/or its Sections.
The material is solely for educational purposes for qualified
health care professionals.
The Transplantation Society and/or its Sections are not liable for
any decision made or action taken based on the information contained in
the material on this site.
The information cannot be used as a substitute for professional
care.
The information does not represent a standard of care.
No physician-patient relationship is being established.