SynthesisRegenerative medicine
Clinical manufacturing of adipose-derived stem cells for therapeutic use: current technologies, quality systems and production challenges.
Synthesis in Regenerative medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis systematic review evaluated manufacturing technologies for adipose-derived stem cells (ADSCs), focusing on automation, quality control, potency, scalability, cost, and regulatory compliance.
methodsFollowing PRISMA guidelines, PubMed, Embase, and Web of Science were searched for English-language studies published January 2020-September 2025. Studies addressing clinical-grade ADSC manufacturing, quality control, regulatory compliance, or production economics were included; non-ADSC studies, reviews, case reports, and conference abstracts were excluded. Two reviewers qualitatively assessed methodological quality and bias. Heterogeneity precluded meta-analysis, so findings were synthesized narratively.
resultsForty-six studies were included; participant numbers were inconsistently reported, as the review focused on manufacturing processes. Automated bioreactors achieved 2- to 10-fold higher yields than flask-based approaches, with improved reproducibility and reduced contamination risk. Five validated platforms were identified. GMP production costs ranged from $15,000 to $50,000 per dose; automation offered potential reductions of 20%-40%. Key limitations included 3- to 5-fold inter-donor variability, 15%-25% batch-to-batch variation, and 5%-10% manufacturing failure rates.
conclusionsADSC manufacturing is progressing toward scalable production, but clinical translation remains constrained by biological variability, limited potency-assay validation, high costs, and regulatory complexity. Standardization and clinically relevant potency assays are needed to improve consistency and access.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.