Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Processing Adipose Tissue Samples in a GMP Environment Standardizes Their Use in Cell Therapy Treatments. Data on 302 Patients

Version 1 : Received: 16 May 2023 / Approved: 17 May 2023 / Online: 17 May 2023 (09:53:20 CEST)

How to cite: Cremona, M.; Rusconi, G.; Ferrario, A.; Mariotta, L.; Gola, M.; Soldati, G. Processing Adipose Tissue Samples in a GMP Environment Standardizes Their Use in Cell Therapy Treatments. Data on 302 Patients. Preprints 2023, 2023051216. https://doi.org/10.20944/preprints202305.1216.v1 Cremona, M.; Rusconi, G.; Ferrario, A.; Mariotta, L.; Gola, M.; Soldati, G. Processing Adipose Tissue Samples in a GMP Environment Standardizes Their Use in Cell Therapy Treatments. Data on 302 Patients. Preprints 2023, 2023051216. https://doi.org/10.20944/preprints202305.1216.v1

Abstract

The adipose-derived mesenchymal stem cells are becoming the tool of choice for many clinical applications and nowadays, nearly 200 clinical trials are running worldwide to prove the efficacy of this cell type for many diseases and pathological conditions. To reach the goal of cell therapies and produce ATMPs as drugs for regenerative medicine, it is necessary to properly standardize the GMP processes and thus collection methods, transportation strategies, extraction protocols and characterization procedures without forgetting that all the tissues of the human body are characterized by a wide inter-individual variability genetically determined and acquired during life. Here we compare 302 samples processed under GMP rules to exclude the influence of the operator and of the anatomical site of collection. Variability in the age of patients, gender and laboratory parameters like total cell number, cell viability, stem cell number and other stromal vascular fraction cell sub-populations have been compared to each other. Results show that, when the laboratory protocol is standardized, the variability in quantifiable cell parameters is widely statistically non-significant, meaning that we can make a further step toward standardized advanced cell therapy products.

Keywords

Adipose-derived stem cells; human cell therapy; mesenchymal stem cells; endothelial cells; pericytes; GMP-compliant-facility; clean room; ATMPs

Subject

Medicine and Pharmacology, Other

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