ArticleStem cell research & therapy2015
Generation of clinical-grade human induced pluripotent stem cells in Xeno-free conditions.
Article in Stem cell research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.
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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.
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Who cites it
30 citing papers in PubMed, 63 citations in OpenAlex.
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- Xeno-free generation of human induced pluripotent stem cells from donor-matched fibroblasts isolated from dermal and oral tissues.Stem cell research & therapy · 2023Article
- iPSC-based approach for human hair follicle regeneration.Frontiers in cell and developmental biology · 2023Review
- Manufacturing clinical-grade human induced pluripotent stem cell-derived beta cells for diabetes treatment.Cell proliferation · 2022Review
- Scalable manufacturing of clinical-grade differentiated cardiomyocytes derived from human-induced pluripotent stem cells for regenerative therapy.Cell proliferation · 2022Review
- Biobanking of human pluripotent stem cells in China.Cell proliferation · 2022Article
- Improving Cell Recovery: Freezing and Thawing Optimization of Induced Pluripotent Stem Cells.Cells · 2022Review
- Stem Cell Studies in Cardiovascular Biology and Medicine: A Possible Key Role of Macrophages.Biology · 2022Review
- Motor neuron-derived induced pluripotent stem cells as a drug screening platform for amyotrophic lateral sclerosis.Frontiers in cell and developmental biology · 2022Review
- Amniotic fluid stem cells: A novel treatment for necrotizing enterocolitis.Frontiers in pediatrics · 2022Review
- Sand-mediated ice seeding enables serum-free low-cryoprotectant cryopreservation of human induced pluripotent stem cells.Bioactive materials · 2021Article
- Reprogramming: Emerging Strategies to Rejuvenate Aging Cells and Tissues.International journal of molecular sciences · 2021Review
- The Chinese National Stem Cell Resource Center.Stem cell research · 2021Article
- GMP-grade neural progenitor derivation and differentiation from clinical-grade human embryonic stem cells.Stem cell research & therapy · 2020Article
- Synergistic Adhesiveness of Fibronectin with PHSRN Peptide in Gelatin Mixture Promotes the Therapeutic Potential of Human ES-Derived MSCs.Cellular and molecular bioengineering · 2020Article
- Cell-Based Therapy Manufacturing in Stirred Suspension Bioreactor: Thoughts for cGMP Compliance.Frontiers in bioengineering and biotechnology · 2020Review
- Reporter gene-engineering of human induced pluripotent stem cells during differentiation renders in vivo traceable hepatocyte-like cells accessible.Stem cell research · 2019Article
Corrections and comments
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Authors and funding
18 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHuman induced pluripotent stem cells (hiPSCs) are considered as one of the most promising seed cell sources in regenerative medicine. Now hiPSC-based clinical trials are underway. To ensure clinical safety, cells used in clinical trials or therapies should be generated under GMP conditions, and with Xeno-free culture media to avoid possible side effects like immune rejection that induced by the Xeno reagents. However, up to now there are no reports for hiPSC lines developed completely under GMP conditions using Xeno-free reagents.
methodsClinical-grade human foreskin fibroblast (HFF) cells used as feeder cells and parental cells of the clinical-grade hiPSCs were isolated from human foreskin tissues and cultured in Xeno-free media. Clinical-grade hiPSCs were derived by integration-free Sendai virus-based reprogramming kit in Xeno-free pluriton™ reprogramming medium or X medium. Neural cells and cardiomyocytes differentiation were conducted following a series of spatial and temporal specific signals induction according to the corresponding lineage development signals. Biological safety evaluation of the clinical-grade HFF cells and hiPSCs were conducted following the guidance of the "Pharmacopoeia of the People's Republic of China, Edition 2010, Volume III".
resultsWe have successfully derived several integration-free clinical-grade hiPSC lines under GMP-controlled conditions and with Xeno-free reagents culture media in line with the current guidance of international and national evaluation criteria. As for the source of hiPSCs and feeder cells, biological safety evaluation of the HFF cells have been strictly reviewed by the National Institutes for Food and Drug Control (NIFDC). The hiPSC lines are pluripotent and have passed the safety evaluation. Moreover, one of the randomly selected hiPSC lines was capable of differentiating into functional neural cells and cardiomyocytes in Xeno-free culture media.
conclusionThe clinical-grade hiPSC lines therefore could be valuable sources for future hiPSC-based clinical trials or therapies and for drug screening.
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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.