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

Rachel Sagar; Graça Almeida-Porada; Karin Blakemore; Jerry K.Y. Chan; Mahesh Choolani; Cecilia Götherström; Agnes Jaulent; Tippi C. MacKenzie; Citra Mattar; Christopher D. Porada; William H. Peranteau; Holm Schneider; Steven W. Shaw; Simon N. Waddington; Magnus Westgren; Anna L. David

doi:10.1016/j.ymthe.2020.10.012

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

Rachel Sagar, Graça Almeida-Porada, Karin Blakemore, Jerry K.Y. Chan, Mahesh Choolani, Cecilia Götherström, Agnes Jaulent, Tippi C. MacKenzie, Citra Mattar, Christopher D. Porada, William H. Peranteau, Holm Schneider, Steven W. Shaw, Simon N. Waddington, Magnus Westgren, Anna L. David

Research output: Contribution to journal › Review article › peer-review

Original language	English (US)
Pages (from-to)	2316-2319
Number of pages	4
Journal	Molecular Therapy
Volume	28
Issue number	11
DOIs	https://doi.org/10.1016/j.ymthe.2020.10.012
State	Published - Nov 4 2020
Externally published	Yes

Keywords

adverse event
clinical trial
fetal
fetal therapy
In utero stem cell transplantation
maternal
safety

ASJC Scopus subject areas

Molecular Medicine
Molecular Biology
Genetics
Pharmacology
Drug Discovery

Access to Document

10.1016/j.ymthe.2020.10.012

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Sagar, R., Almeida-Porada, G., Blakemore, K., Chan, J. K. Y., Choolani, M., Götherström, C., Jaulent, A., MacKenzie, T. C., Mattar, C., Porada, C. D., Peranteau, W. H., Schneider, H., Shaw, S. W., Waddington, S. N., Westgren, M., & David, A. L. (2020). Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials: iFeTiS Consensus Statement. Molecular Therapy, 28(11), 2316-2319. https://doi.org/10.1016/j.ymthe.2020.10.012

Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials : iFeTiS Consensus Statement. / Sagar, Rachel; Almeida-Porada, Graça; Blakemore, Karin; Chan, Jerry K.Y.; Choolani, Mahesh; Götherström, Cecilia; Jaulent, Agnes; MacKenzie, Tippi C.; Mattar, Citra; Porada, Christopher D.; Peranteau, William H.; Schneider, Holm; Shaw, Steven W.; Waddington, Simon N.; Westgren, Magnus; David, Anna L.

In: Molecular Therapy, Vol. 28, No. 11, 04.11.2020, p. 2316-2319.

Research output: Contribution to journal › Review article › peer-review

Sagar, R, Almeida-Porada, G, Blakemore, K, Chan, JKY, Choolani, M, Götherström, C, Jaulent, A, MacKenzie, TC, Mattar, C, Porada, CD, Peranteau, WH, Schneider, H, Shaw, SW, Waddington, SN, Westgren, M & David, AL 2020, 'Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials: iFeTiS Consensus Statement', Molecular Therapy, vol. 28, no. 11, pp. 2316-2319. https://doi.org/10.1016/j.ymthe.2020.10.012

Sagar, Rachel ; Almeida-Porada, Graça ; Blakemore, Karin ; Chan, Jerry K.Y. ; Choolani, Mahesh ; Götherström, Cecilia ; Jaulent, Agnes ; MacKenzie, Tippi C. ; Mattar, Citra ; Porada, Christopher D. ; Peranteau, William H. ; Schneider, Holm ; Shaw, Steven W. ; Waddington, Simon N. ; Westgren, Magnus ; David, Anna L. / Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials : iFeTiS Consensus Statement. In: Molecular Therapy. 2020 ; Vol. 28, No. 11. pp. 2316-2319.

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title = "Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials: iFeTiS Consensus Statement",

keywords = "adverse event, clinical trial, fetal, fetal therapy, In utero stem cell transplantation, maternal, safety",

author = "Rachel Sagar and Gra{\c c}a Almeida-Porada and Karin Blakemore and Chan, {Jerry K.Y.} and Mahesh Choolani and Cecilia G{\"o}therstr{\"o}m and Agnes Jaulent and MacKenzie, {Tippi C.} and Citra Mattar and Porada, {Christopher D.} and Peranteau, {William H.} and Holm Schneider and Shaw, {Steven W.} and Waddington, {Simon N.} and Magnus Westgren and David, {Anna L.}",

note = "Funding Information: This project has received funding from the European Union{\textquoteright}s Horizon 2020 research and innovation programme under grant agreement no. 681045 , the German Research Foundation (DFG; grant SCHN 569/4-1 to H.S.), and the German Federal Ministry of Education and Research (BMBF; grant 01KG2008 to H.S.). A.L.D. is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre . S.N.W. received funding from MRC grants MR/R015325/1 , MR/N026101/1 , and MR/N026101/1 and NC3Rs grant NC/L001780/1 . G.A.P. and C.P. are supported by NHLBI grants HL130856 , HL135853 , and HL148681 . W.P. is supported by National Institutes of Health grants DP2HL152427 and 1R01DK123049-01 . C.G. and M.W. are supported by the Swedish Research Council ( 921-2014-7209 ). C.M. is funded by Singapore National Medical Research Council grant NMRC/CSA-INV/0012/2016 . S.W.S. is supported by Chang Gung Memorial Hospital CPRPG1J0021 . T.C.M. is supported by the California Institute for Regeneration Medicine . J.K.Y.C. is supported by Singapore Ministry of Health{\textquoteright}s National Medical Research Council ( CSA-SI/008.2016 , CIRG/1484/2018 , and CIRG/1459/2016 ). H.S. is supported by the National Foundation for Ectodermal Dysplasias (NFED) and the German-Swiss-Austrian Ectodermal Dysplasia Patient Organization ; he also received research funding related to this project from Edimer Pharmaceuticals and the EspeRare Foundation . A.J., via the EspeRare foundation , has received philanthropic funding from the Dioraphte Foundation , Fondation Pictet , a Private Geneva Foundation , and a private donation. Funding Information: This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement no. 681045, the German Research Foundation (DFG; grant SCHN 569/4-1 to H.S.), and the German Federal Ministry of Education and Research (BMBF; grant 01KG2008 to H.S.). A.L.D. is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre. S.N.W. received funding from MRC grants MR/R015325/1, MR/N026101/1, and MR/N026101/1 and NC3Rs grant NC/L001780/1. G.A.P. and C.P. are supported by NHLBI grants HL130856, HL135853, and HL148681. W.P. is supported by National Institutes of Health grants DP2HL152427 and 1R01DK123049-01. C.G. and M.W. are supported by the Swedish Research Council (921-2014-7209). C.M. is funded by Singapore National Medical Research Council grant NMRC/CSA-INV/0012/2016. S.W.S. is supported by Chang Gung Memorial Hospital CPRPG1J0021. T.C.M. is supported by the California Institute for Regeneration Medicine. J.K.Y.C. is supported by Singapore Ministry of Health's National Medical Research Council (CSA-SI/008.2016, CIRG/1484/2018, and CIRG/1459/2016). H.S. is supported by the National Foundation for Ectodermal Dysplasias (NFED) and the German-Swiss-Austrian Ectodermal Dysplasia Patient Organization; he also received research funding related to this project from Edimer Pharmaceuticals and the EspeRare Foundation. A.J. via the EspeRare foundation, has received philanthropic funding from the Dioraphte Foundation, Fondation Pictet, a Private Geneva Foundation, and a private donation.",

year = "2020",

month = nov,

day = "4",

doi = "10.1016/j.ymthe.2020.10.012",

language = "English (US)",

volume = "28",

pages = "2316--2319",

journal = "Molecular Therapy",

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TY - JOUR

T1 - Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials

T2 - iFeTiS Consensus Statement

AU - Sagar, Rachel

AU - Almeida-Porada, Graça

AU - Blakemore, Karin

AU - Chan, Jerry K.Y.

AU - Choolani, Mahesh

AU - Götherström, Cecilia

AU - Jaulent, Agnes

AU - MacKenzie, Tippi C.

AU - Mattar, Citra

AU - Porada, Christopher D.

AU - Peranteau, William H.

AU - Schneider, Holm

AU - Shaw, Steven W.

AU - Waddington, Simon N.

AU - Westgren, Magnus

AU - David, Anna L.

N1 - Funding Information: This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 681045 , the German Research Foundation (DFG; grant SCHN 569/4-1 to H.S.), and the German Federal Ministry of Education and Research (BMBF; grant 01KG2008 to H.S.). A.L.D. is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre . S.N.W. received funding from MRC grants MR/R015325/1 , MR/N026101/1 , and MR/N026101/1 and NC3Rs grant NC/L001780/1 . G.A.P. and C.P. are supported by NHLBI grants HL130856 , HL135853 , and HL148681 . W.P. is supported by National Institutes of Health grants DP2HL152427 and 1R01DK123049-01 . C.G. and M.W. are supported by the Swedish Research Council ( 921-2014-7209 ). C.M. is funded by Singapore National Medical Research Council grant NMRC/CSA-INV/0012/2016 . S.W.S. is supported by Chang Gung Memorial Hospital CPRPG1J0021 . T.C.M. is supported by the California Institute for Regeneration Medicine . J.K.Y.C. is supported by Singapore Ministry of Health’s National Medical Research Council ( CSA-SI/008.2016 , CIRG/1484/2018 , and CIRG/1459/2016 ). H.S. is supported by the National Foundation for Ectodermal Dysplasias (NFED) and the German-Swiss-Austrian Ectodermal Dysplasia Patient Organization ; he also received research funding related to this project from Edimer Pharmaceuticals and the EspeRare Foundation . A.J., via the EspeRare foundation , has received philanthropic funding from the Dioraphte Foundation , Fondation Pictet , a Private Geneva Foundation , and a private donation. Funding Information: This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement no. 681045, the German Research Foundation (DFG; grant SCHN 569/4-1 to H.S.), and the German Federal Ministry of Education and Research (BMBF; grant 01KG2008 to H.S.). A.L.D. is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre. S.N.W. received funding from MRC grants MR/R015325/1, MR/N026101/1, and MR/N026101/1 and NC3Rs grant NC/L001780/1. G.A.P. and C.P. are supported by NHLBI grants HL130856, HL135853, and HL148681. W.P. is supported by National Institutes of Health grants DP2HL152427 and 1R01DK123049-01. C.G. and M.W. are supported by the Swedish Research Council (921-2014-7209). C.M. is funded by Singapore National Medical Research Council grant NMRC/CSA-INV/0012/2016. S.W.S. is supported by Chang Gung Memorial Hospital CPRPG1J0021. T.C.M. is supported by the California Institute for Regeneration Medicine. J.K.Y.C. is supported by Singapore Ministry of Health's National Medical Research Council (CSA-SI/008.2016, CIRG/1484/2018, and CIRG/1459/2016). H.S. is supported by the National Foundation for Ectodermal Dysplasias (NFED) and the German-Swiss-Austrian Ectodermal Dysplasia Patient Organization; he also received research funding related to this project from Edimer Pharmaceuticals and the EspeRare Foundation. A.J. via the EspeRare foundation, has received philanthropic funding from the Dioraphte Foundation, Fondation Pictet, a Private Geneva Foundation, and a private donation.

PY - 2020/11/4

Y1 - 2020/11/4

KW - adverse event

KW - clinical trial

KW - fetal

KW - fetal therapy

KW - In utero stem cell transplantation

KW - maternal

KW - safety

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DO - 10.1016/j.ymthe.2020.10.012

M3 - Review article

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VL - 28

SP - 2316

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JO - Molecular Therapy

JF - Molecular Therapy

SN - 1525-0016

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ER -

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

Keywords

ASJC Scopus subject areas

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