ISPD Collaboration Corner

The ISPD Collaboration Corner is a pathway for building inter-disciplinary research in fetal conditions and treatment. We invite interested researchers who are seeking additional investigators or patients to have their study posted here for a period of 30 days by completing the submission form provided on this page.

Listed below are studies seeking additional investigators and/or patients. If you are interested in participating in one of the studies listed on this page, please use the email address provided to contact the researcher directly.

Collaboration Posters — ISPD also accepts abstracts for collaboration posters at the annual conference. This poster format makes a great conversation starter for researchers who are seeking collaboration on research, feedback on study design, etc. Look for a link to the next upcoming conference on the ISPD home page.

 

Principal Investigators

Are you seeking additional investigators and/or patients for your study? Please complete and submit the study listing form to have your study listed on this page.

Submit a Study Listing

If you prefer, you may use a PDF submission form instead.

Studies will be posted for 300 days. If you need to make changes to your posting during that time, please contact the ISPD webmaster.

STUDY POSTINGS

 2020-08-27_BostonChildrens_OrbachD
(8/27/2020)
 
   

Study Name:  Fetal Intervention for Vein of Galen Malformation

Principal Investigator: Darren Orbach, MD PhD, Boston Children's Hospital Cerebrovascular Surgery & Interventions Center / Maternal Fetal Care Center, darren.orbach@childrens.harvard.edu

Collaborating Investigator(s) Sought: No

Patients Sought:  Candidates must have an in utero anatomic diagnosis of vein of Galen malformation, must be between 23 weeks and term gestational age, and must have well preserved brain parenchyma. Fetal MRI will be used to screen for appropriate subjects for the study. We will enroll 20 subjects on this trial.

Additional Information: We are conducting a clinical trial that may be of interest to you and your patients. This is a prospective, single-arm non-randomized study to assess the safety and efficacy of fetal embolization of vein of Galen malformations. As opposed to neonatal embolization, we believe that achieving flow diminution through the malformation by partial occlusion of the venous varix in utero would preempt development of pulmonary hypertension and likely protect both brain and heart from steal-related ischemia. As an additional benefit, morbidity to lower-extremity arteries from femoral catheterization in small infants would be avoided. Moreover, as prenatal treatment would be performed under ultrasound rather than fluoroscopy, procedural exposure to ionizing radiation would also be avoided.

Boston Children’s Hospital is a national and international referring center for management of vein of Galen malformations with a well-established multidisciplinary consultation pathway at the Maternal Fetal Care Center (MFCC). The trial is being conducted by a multidisciplinary group of specialists from the Boston Children’s Hospital Maternal Fetal Care Center, the Boston Children’s Cerebrovascular Surgery and Interventions Center, and Brigham and Women’s Hospital Maternal Fetal Medicine Group. This clinical group has significant expertise and has pioneered the development of fetal cardiac interventions for severe congenital heart anomalies, a different needle-based intervention. The fetal embolization intervention will be performed at Brigham and Women’s Hospital.

We are happy to provide more information about this trial upon request. If you have a patient who may be interested in this trial, please ask them to contact the Maternal Fetal Care Center at Boston Children’s Hospital, at 617-355-6512.

Recruitment Letter to Physicians

Funding:  Departmental research funds



 

 2020-08-14_Columbia_BaptisteC
(8/14/2020)
 
   

Study Name: Development of neurofilament as a biomarker of fetal spinal muscular atrophy

Principal Investigator: Caitlin Baptiste, MD, Columbia University Irving Medical Center, cb2670@cumc.columbia.edu

Collaborating Investigator(s) Sought: No

Patients Sought: We are investigating fetal spinal muscular atrophy (SMA). Our aim is to develop a fetal biomarker for SMA disease activity to better understand the prenatal disease phenotype.

Subjects must be carrying a fetus with homozygous gene deletion of SMN1 and <4 copies of SMN2. We will measure neurofilament concentrations, an established biomarker of disease activity, to study the progression of SMA in utero. We will evaluate neurofilament concentrations in the maternal serum, maternal urine, amniotic fluid, and fetal cord blood. Specimens will be collected during routine prenatal lab work and at the time of delivery. No additional procedures or visits will be required of subjects.

Additional Information: This study aims to improve our understanding of fetal SMA as an early step toward evaluating in utero therapy for this condition. There is no direct benefit to participants and we will not be offering in utero gene therapy as a part of this study.

Funding: Departmental funding through the division of maternal fetal medicine



 

 2020-04-09_UNC_VoraN
(4/9/2020)
 
   

Study Name: Fetal Exome

Principal Investigator: Neeta Vora, MD, University of North Carolina

Study coordinator: Kelly Gilmore, University of North Carolina, kelly_gilmore@med.unc.edu

Collaborating Investigator(s) Sought: No

Patients Sought: We have IRB approval to do trio whole exome sequencing on continuing or non-continuing pregnancies as long as fetal DNA and parental DNA is available. Chromosomal microarray must be normal. We are focusing on renal and brain anomalies, in isolation or multisystem which can affect other organ systems as well. Please contact Ms. Gilmore for questions about eligibility.

Funding: Not disclosed



 

 2020-04-03_IRCEP_WyszynskiD_Hernandez-DiazS
(4/3/2020)
 
   

Patient Registry Name:  International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

Principals: Diego Wyszynski MD, MHS, PhD (UK), Sonia Hernandez-Diaz MD, MPH, DrPH (USA)

Collaborating Investigator(s) Sought: No

Patients Sought:  Women who are pregnant or contemplating becoming pregnant, and who are or may be infected with the SARS-CoV-2 virus, the cause of COVID-19. This is a comprehensive site with resources for Moms, families, doctors, nurses, caregivers and researchers, updated medical articles of note, interviews with experts and videos, and a Mom's portal to Track pregnancy, Be Informed, and Chat With Other Moms.

Patient Registry Website: corona.pregistry.com

Funding: Not disclosed



 

 2020-03-30_UCSF_JacobyV
(3/30/2020)
 
   

Registry Name:  PRIORITY: Pregnancy CoRonavIrus Outcomes RegIsTrY

Principals: Vanessa Jacoby, MD, MAS, et al., University of California - San Francisco, PRIORITYCOVID19@ucsf.edu

Collaborating Investigator(s) Sought: No

Patients Sought: Yes. HOW TO REFER A PATIENT - (Suspected/Under Investigation OR Confirmed Case, any language spoken): You do not need IRB or Research Ethics Board approval at your site because no research activities will occur there. Please ask the patient if she is willing to have her contact information shared with us. If yes, you can click here to Refer a Patient, or call/text 415-754-3749, or email at PRIORITYCOVID19@ucsf.edu. The patient can also contact us herself at For Patients: Enroll in PRIORITY. We will then reach out directly to her to consent, enroll, and begin data collection. Here are more details about the study procedures: Information for Providers. If you are willing, please circulate to your colleagues.

Registry Website: priority.ucsf.edu

Registry Flier: PRIORITY Study Flier

Funding: Not disclosed



 

 2020-03-09_UCSF_MacKenkieT
(3/9/2020)
 
   

Study Name: A SINGLE-CENTER, NON-RANDOMIZED STUDY OF THE SAFETY AND EFFICACY OF IN UTERO HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR THE TREATMENT OF FETUSES WITH ALPHA THALASSEMIA MAJOR

Principal Investigator: Tippi MacKenzie, MD, University of California - San Francisco, tippi.mackenzie@ucsf.edu

Collaborating Investigator(s) Sought: No

Patients Sought: Male or female fetuses 180/7-260/7 weeks gestational age, diagnosed with alpha thalassemia major by either chorionic villus sampling (CVS), amniocentesis, or cordocentesis, or by identification of parents as genetic carriers and identification of fetal anemia, for whom parents elect to pursue IUT, and undergo subsequent IUT for the remainder of gestation. 
Fetal subjects who have received prior IUT may be included. 
Fetal subjects with other alpha thalassemia variants who present with clinic or laboratory characteristics consistent with Hemoglobin Barts syndrome will be included.

Funding: CIRM



 

If no studies are listed, there have been no studies submitted within the last 30 days. Please return to check for further postings.

ISPD does not review nor specifically endorse any study posted to the Collaboration Corner. ISPD acts solely in the capacity as a facilitator. The submitter is responsible for the accuracy of the information provided and agrees to having the email address of the principal investigator posted on the ISPD website where it is visible to the general public.