Process data of allogeneic ex vivo-expanded ABCB5⁺ mesenchymal stromal cells for human use: off-the-shelf GMP-manufactured donor-independent ATMP.

ABSTRACT:

Background

Human dermal mesenchymal stromal cells (MSCs) expressing the ATP-binding cassette (ABC) efflux transporter ABCB5 represent an easily accessible MSC population that, based on preclinical and first-in-human data, holds significant promise to treat a broad spectrum of conditions associated not only with skin-related but also systemic inflammatory and/or degenerative processes.

Methods

We have developed a validated Good Manufacturing Practice-compliant expansion and manufacturing process by which ABCB5⁺ MSCs derived from surgical discard skin tissues are processed to an advanced-therapy medicinal product (ATMP) for clinical use. Enrichment for ABCB5⁺ MSCs is achieved in a three-step process involving plastic adherence selection, expansion in a hi

SUBMITTER: Ballikaya S 

PROVIDER: S-EPMC7667860 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature