Abstract
BackgroundEven though the manufacturing processes of the stromal vascular fraction for clinical use are performed in compliance with the good manufacturing practices applying to advanced therapy medicinal products, specifications related to stromal vascular fraction quality remain poorly defined. We analyzed stromal vascular fraction clinical batches from two independent good manufacturing practices-compliant manufacturing facilities, the Swiss Stem Cell Foundation (SSCF) and Marseille University Hospitals (AP-HM), with the goal of defining appropriate and harmonized release acceptance criteria.MethodsThis retrospective analysis reviewed the biological characteristics of 364 batches of clinical-grade stromal vascular fraction. Collected data included cell viability, recovery yield, cell subset distribution of stromal vascular fraction, and microbiological quality.ResultsStromal vascular fraction from SSCF cohort demonstrated a higher viability (89.33% ± 4.30%) and recovery yield (2.54 × 105 ± 1.22 × 105 viable nucleated cells (VNCs) per mL of adipose tissue) than stromal vascular fraction from AP-HM (84.20% ± 5.96% and 2.25 × 105 ± 1.11 × 105 VNCs per mL). AP-HM batches were significantly less contaminated (95.71% of sterile batches versus 74.15% for SSCF batches). The cell subset distribution was significantly different (higher proportion of endothelial cells and lower proportion of leukocytes and pericytes in SSCF cohort).ConclusionsBoth centers agreed that a good manufacturing practices-compliant stromal vascular fraction batch should exert a viability equal or superior to 80%, a minimum recovery yield of 1.50 × 105 VNCs per mL of adipose tissue, a proportion of adipose-derived stromal cells at least equal to 20%, and a proportion of leukocytes under 50%. In addition, a multiparameter gating strategy for stromal vascular fraction analysis is proposed.
Highlights
Even though the manufacturing processes of the stromal vascular fraction for clinical use are performed in compliance with the good manufacturing practices applying to advanced therapy medicinal products, specifications related to stromal vascular fraction quality remain poorly defined
François et al Stem Cell Research & Therapy (2021) 12:373. Both centers agreed that a good manufacturing practices-compliant stromal vascular fraction batch should exert a viability equal or superior to 80%, a minimum recovery yield of 1.50 × 105 Viable nucleated cell (VNC) per mL of adipose tissue, a proportion of adipose-derived stromal cells at least equal to 20%, and a proportion of leukocytes under 50%
Donor specifications adipose tissue (AT) was obtained from two cohorts of patients included either in the service offered by Swiss Stem Cell Foundation (SSCF), Switzerland, for aesthetic purpose or in the French clinical trials listed in supplemental table 1
Summary
Even though the manufacturing processes of the stromal vascular fraction for clinical use are performed in compliance with the good manufacturing practices applying to advanced therapy medicinal products, specifications related to stromal vascular fraction quality remain poorly defined. The stromal vascular fraction (SVF) is an heterogeneous cell population extracted from adipose tissue (AT) [1,2,3] For several years, it has been classified as an advanced therapy medicinal product (ATMP) and evaluated in multiple clinical trials for its regenerative ability. Initially formalized by Bourin et al, the SVF contains at least 15% of mesenchymal stromal/stem cells (MSCs) called adipose-derived stromal cells (ASCs), 10 to 20% of endothelial cells and progenitors (ECs), and about 4% of pericytes (PRs) These different cell subsets cooperate to promote synergistic angiogenic, immunomodulatory, and trophic effects [4]. The viability of the cell product is always determined as it conditions cell integrity and function and is essential to ensure a potential therapeutic effect In this context, SVF viability is often considered as the main specification of the final ATMP. Flow cytometry analysis of clinical grade SVF and results’
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