Lentiviral Hematopoietic Stem Cell Gene Therapy in Patients with Wiskott-Aldrich Syndrome

Генная терапия гемопоэтическими стволовыми клетками с использованием лентивирусного вектора у пациентов с синдромом Вискотта—Олдрича
Alessandro Aiuti, Luca Biasco, Samantha Scaramuzza, Francesca Ferrua, Maria Pia Cicalese, Cristina Baricordi, Francesca Dionisio, Andrea Calabria, Stefania Giannelli, Maria Carmina Castiello, Marita Bosticardo, Costanza Evangelio, Andrea Assanelli, Miriam Casiraghi, Sara Di Nunzio, Luciano Callegaro, Claudia Benati, Paolo Rizzardi, Danilo Pellin, Clelia Di Serio, Manfred Schmidt, Christof von Kalle, Jason P. Gardner, Nalini Mehta, Victor Neduva, David J. Dow, Anne Galy, R Miniero, Andrea Finocchi, Ayşe Metìn, Pinaki P. Banerjee, Jordan S. Orange, Stefania Galimberti, Maria Grazia Valsecchi, Alessandra Biffi, Eugenio Montini, Anna Villa, Fabio Ciceri, Maria Grazia Roncarolo, Luigi Naldini
2013-07-12

Wiskott-Aldrich syndromeex vivo gene transferhematopoietic stem cellslentiviral gene therapyproto-oncogene integration
Next-Generation Gene Therapy Few disciplines in contemporary clinical research have experienced the high expectations directed at the gene therapy field. However, gene therapy has been challenging to translate to the clinic, often because the therapeutic gene is expressed at insufficient levels in the patient or because the gene delivery vector integrates near protooncogenes, which can cause leukemia (see the Perspective by Verma ). Biffi et al. ( 1233158 , published online 11 July) and Aiuti et al. ( 1233151 ; published online 11 July) report progress on both fronts in gene therapy trials of three patients with metachromatic leukodystrophy (MLD), a neurodegenerative disorder, and three patients with Wiskott-Aldrich syndrome (WAS), an immunodeficiency disorder. Optimized lentiviral vectors were used to introduce functional MLD or WAS genes into the patients' hematopoietic stem cells (HSCs) ex vivo, and the transduced cells were then infused back into the patients, who were then monitored for up to 2 years. In both trials, the patients showed stable engraftment of the transduced HSC and high expression levels of functional MLD or WAS genes. Encouragingly, there was no evidence of lentiviral vector integration near proto-oncogenes, and the gene therapy treatment halted disease progression in most patients. A longer follow-up period will be needed to further validate efficacy and safety.
1
Longer follow-up is required to further validate the treatment’s long-term efficacy and safety.
2
No evidence was found of lentiviral vector integration near proto-oncogenes, addressing a major gene-therapy safety concern.
3
Optimized lentiviral vectors successfully introduced functional WAS genes into patients’ hematopoietic stem cells ex vivo.
4
The therapy halted disease progression in most patients with Wiskott-Aldrich syndrome.
5
Treated patients demonstrated stable engraftment of transduced hematopoietic stem cells and high expression of functional WAS genes for up to 2 years.

Lentiviral hematopoietic stem cell gene therapy in patients with Wiskott-Aldrich syndrome

Stable engraftment and functional WAS gene expression, along with treatment efficacy and lentiviral integration safety

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2013-07-12
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Authors
Alessandro Aiuti
Luca Biasco
Samantha Scaramuzza
Francesca Ferrua
Maria Pia Cicalese
Cristina Baricordi
Francesca Dionisio
Andrea Calabria
Stefania Giannelli
Maria Carmina Castiello
Marita Bosticardo
Costanza Evangelio
Andrea Assanelli
Miriam Casiraghi
Sara Di Nunzio
Luciano Callegaro
Claudia Benati
Paolo Rizzardi
Danilo Pellin
Clelia Di Serio
Manfred Schmidt
Christof von Kalle
Jason P. Gardner
Nalini Mehta
Victor Neduva
David J. Dow
Anne Galy
R Miniero
Andrea Finocchi
Ayşe Metìn
Pinaki P. Banerjee
Jordan S. Orange
Stefania Galimberti
Maria Grazia Valsecchi
Alessandra Biffi
Eugenio Montini
Anna Villa
Fabio Ciceri
Maria Grazia Roncarolo
Luigi Naldini
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