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Creation of a GLP bank of immune-privileged, immortal mesoangioblasts to treat monogenic, recessive diseases of muscle and connective tissue

Project description

Mesoangioblasts biobank to treat muscle genetic diseases

Stem cells have been used to treat blood and epithelial diseases, but challenges persist with muscle and brain disorders. NHS treatment costs are unsustainable. Current trials involve modified mesoangioblasts (Mabs) to enhance dystrophin production and the development of immune-privileged Mabs derived from patients with muscular dystrophy. The ERC-funded MABank project aims to generate Mabs from healthy donors and establish a GMP biobank of these customisable Mabs, tailored to specific genetic mutations and made available for patient treatment under the principle of ‘one serves many’. Access to suitable cells, a GMP-grade lentivector carrying the wild-type cDNA of mutated genes, and a mouse model for preclinical testing will facilitate trials for rare diseases lacking effective therapies.

Objective

Stem cells led to effective cures for diseases of blood and epithelia. However, in the case of diseases affecting muscles, connective tissue or brain, significant challenges persist for expansion of a sufficient number of corrected cells, delivery and engraftment. Even when these problems will be solved the prospective per-patient cost of the treatment (up to 2M$) will make such therapies unsustainable for NHS. We developed protocols of cell therapy using mesoangioblasts (Mabs), vessel associated progenitors that, despite promising results in animal models, showed modest efficacy in patients. To address this, we transplanted autologous dystrophic Mabs expressing a small nuclear RNA engineered to skip dystrophin exon 51, that enters and corrects also neighboring nuclei of the multinucleated muscle fiber, thus bringing dystrophic production to therapeutic levels. A Phase I/IIa trial is currently running. Even in case of success, the cost would remain prohibitive.
Through the ongoing ERC ADG 884952-UniMab, we are completing the development of immortal, immune-privileged Mabs from dystrophic patients thanks to genome editing of HLA and the expression of tolerogenic proteins. In this PoC project we will produce universal Mabs from healthy donors and will study the feasibility of producing and storing a large amount of universal Mabs through a bank of universal donor Mabs from healthy patients, ready to be corrected for the specific genetic mutation and injected into the patient following the motto “one serve many”. Available cells, a GMP-grade lentivector, expressing the wt cDNA of the mutated gene and a mouse model for pre-clinical tests would be sufficient to start a trial even for extremely rare diseases that currently lack even the hope of a therapy. This work will enable the business exploitation of the MABANK technology, by creating a company with a GMP biobank that may operate internally and make cells available to clinicians and Biotech companies.

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HORIZON-ERC-POC - HORIZON ERC Proof of Concept Grants

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Call for proposal

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(opens in new window) ERC-2023-POC

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Host institution

OSPEDALE SAN RAFFAELE SRL
Net EU contribution

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€ 115 000,00
Address
VIA OLGETTINA 60
20132 Milano
Italy

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Region
Nord-Ovest Lombardia Milano
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

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Beneficiaries (2)

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