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Universal Satellite Cell-like Stem Cells for Muscle Regeneration: AI-powered Cell Engineering, Manufacturing and Precision Delivery

Objective

MyoSTAR will develop the first scalable, allogeneic, off-the-shelf muscle stem cell therapy, placing Europe at the forefront of regenerative medicine. Muscle-wasting diseases and injuries affect over 20 million Europeans in emergency care, orthopedics, neurology, trauma, and iatrogenic settings, causing disability, loss of independence, premature death, and rising healthcare costs. Current treatments are mainly symptomatic and do not restore muscle function. Skeletal muscle regenerates via satellite cells and autologous muscle stem cell therapies have shown promise, especially in pediatric and orphan diseases. Much of this innovation has been pioneered in Europe, with the consortium partner MyoPax among the leaders. Yet, broad use is limited by complex manufacturing, distribution limits, immune rejection, inconsistent quality and safety, and the lack of standardized delivery. MyoSTAR will overcome these barriers by creating immune-cloaked, safety-equipped induced satellite cells (iSats) from hiPSCs - a universal, robust, readily available regenerative source. AI-powered quality control will ensure genomic integrity; closed-system GMP workflows will streamline manufacturing, and new potency assays will link in vitro function to in vivo regeneration. To ensure clinical adoption, a robotic injection system will deliver iSats with precision and consistency. Seven leading partners from industry, biotech, and academia unite expertise to establish a fully preclinically validated, GMP- and regulator-ready iSat product, advancing to first-in-human trials in post-prostatectomy incontinence, a disabling condition with no regenerative option. Beyond this, the platform will expand to broader muscular diseases. By advancing stem cell engineering, AI-driven manufacturing, and precision delivery, MyoSTAR will create the first clinically ready, scalable platform for muscle regeneration offering realistic curative options and positioning Europe´s leadership in stem cell innovation.

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Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-RIA - HORIZON Research and Innovation Actions

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Call for proposal

(opens in new window) HORIZON-HLTH-2025-01

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Coordinator

MYOPAX GMBH
Net EU contribution
€ 2 238 750,00
Address
Mullerstrasse 178
13353 Berlin
Germany
SME
Yes
Region
Berlin Berlin Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 5 477 500,00

Participants (7)