Acceptability of In Utero Hematopoietic Cell Transplantation for Sickle Cell Disease

Antiel, Ryan M.; Halpern, Scott D.; Stevens, Evelyn; Vrecenak, Jesse D.; Patterson, Chavis A.; Tchume‐Johnson, Trudy; Smith‐Whitley, Kim; Peranteau, William H.; Flake, Alan W.; Barakat, Lamia P.

doi:10.1177/0272989x17707214

Cited by 6 publications

(1 citation statement)

References 31 publications

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“…To reduce maternal and fetal pain or discomfort the procedure is performed under local anaesthetic, and similar needling procedures for fetal blood transfusion are generally well tolerated. Severe maternal complications such as maternal bowel injury are uncommon probably because the procedure is ultrasound-guided (<0.1%) 13 . Maternal deaths are rarely reported after amniocentesis, mainly associated with Escherichia coli bacterial infection.…”

Section: Consensus Statementmentioning

confidence: 99%

Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials: iFeTiS Consensus Statement

et al. 2020

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Section: Consensus Statementmentioning

confidence: 99%

Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials: iFeTiS Consensus Statement

et al. 2020

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Improving Development of Drug Treatments for Pregnant Women and the Fetus

David

Ahmadzia

Ashcroft

et al. 2022

Ther Innov Regul Sci

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The exclusion of pregnant populations, women of reproductive age, and the fetus from clinical trials of therapeutics is a major global public health issue. It is also a problem of inequity in medicines development, as pregnancy is a protected characteristic. The current regulatory requirements for drugs in pregnancy are being analyzed by a number of agencies worldwide. There has been considerable investment in developing expertise in pregnancy clinical trials (for the pregnant person and the fetus) such as the Obstetric-Fetal Pharmacology Research Centers funded by the National Institute of Child Health and Human Development. Progress has also been made in how to define and grade clinical trial safety in pregnant women, the fetus, and neonate. Innovative methods to model human pregnancy physiology and pharmacology using computer simulations are also gaining interest. Novel ways to assess fetal well-being and placental function using magnetic resonance imaging, computerized cardiotocography, serum circulating fetoplacental proteins, and mRNA may permit better assessment of the safety and efficacy of interventions in the mother and fetus. The core outcomes in women’s and newborn health initiative is facilitating the consistent reporting of data from pregnancy trials. Electronic medical records integrated with pharmacy services should improve the strength of pharmacoepidemiologic and pharmacovigilance studies. Incentives such as investigational plans and orphan disease designation have been taken up for obstetric, fetal, and neonatal diseases. This review describes the progress that is being made to better understand the extent of the problem and to develop applicable solutions.

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Embryonic intraventricular transplantation of neural stem cells augments inflammation-induced prenatal brain injury

Borhani-Haghighi

Kashani

Mohamadi

et al. 2018

Journal of Chemical Neuroanatomy

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Acceptability of In Utero Hematopoietic Cell Transplantation for Sickle Cell Disease

Abstract: This study suggests that the majority of parents >and young adults would consider IUHCT under expected therapeutic conditions.

Cited by 6 publications

References 31 publications

Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials: iFeTiS Consensus Statement

Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials: iFeTiS Consensus Statement

Improving Development of Drug Treatments for Pregnant Women and the Fetus

Embryonic intraventricular transplantation of neural stem cells augments inflammation-induced prenatal brain injury

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