ReviewStem cells translational medicine2021
Regulatory considerations for developing a phase I investigational new drug application for autologous induced pluripotent stem cells-based therapy product.
Review in Stem cells translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.
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
44 citing papers in PubMed.
- CAR-engineered neutrophils derived from induced pluripotent stem cells: a new frontier in cellular immunotherapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- In Vivo Direct Reprogramming: Current Progress and Future Prospects from Mechanisms to Therapeutic Application.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Stem cell-based therapies for neuroretinal degeneration: current landscape and future perspectives.Stem cells translational medicine · 2026Review
- Exploring CAR cell therapies beyond CAR-T for myeloid malignancies.Journal of biomedical science · 2026Review
- Metronidazole-Loaded Cyclodextrin Nanogels for Antibacterial Therapy and Microbiota Regulation in Periodontitis.Advanced healthcare materials · 2026Article
- Urine-derived induced pluripotent stem cells for non-invasive diagnosis of bladder cancer.Journal of Cancer · 2026Review
- Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU.Frontiers in medicine · 2026Review
- Quality control strategy for differentiating induced pluripotent stem cells into pancreatic β-cells before transplantation.Regenerative medicine · 2026Review
- Stem cell dysfunction and rejuvenation strategies in ageing: emerging advances in regenerative medicine.Frontiers in cell and developmental biology · 2026Review
- Elimination of tumorigenic pluripotent stem cells from their differentiated cell therapy products: An important step toward ensuring safe cell therapy.Stem cell reports · 2025Review
- Transformative Potential of Induced Pluripotent Stem Cells in Congenital Heart Disease Research and Treatment.Children (Basel, Switzerland) · 2025Review
- Generation and purification of iPSC-derived cardiomyocytes for clinical applications.Stem cell research & therapy · 2025Article
- Delivering living medicines with biomaterials.Nature reviews. Materials · 2025Article
- Automated and Enclosed Three-Dimensional Biofabrication System for Mesenchymal Stem Cell Culture to Enhance Diabetic Wound Healing.Biomaterials research · 2025Article
- Establishment of subcutaneous transplantation platform for delivering induced pluripotent stem cell-derived insulin-producing cells.PloS one · 2025Article
- Clinical translation of human iPSC technologies: advances, safety concerns, and future directions.Frontiers in cell and developmental biology · 2025Review
- Considerations for the development of iPSC-derived cell therapies: a review of key challenges by the JSRM-ISCT iPSC Committee.Cytotherapy · 2024Review
- Cell therapy for neurological disorders.Nature medicine · 2024Review
- Article
- iPSC-Derived Cardiomyocytes as a Disease Model to Understand the Biology of Congenital Heart Defects.Cells · 2024Review
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
Induced pluripotent stem cells (iPSC)-based therapies have been hailed as the future of regenerative medicine because of their potential to provide treatment options for most degenerative diseases. A key promise of iPSC-based therapies is the possibility of an autologous transplant that may engraft better in the longer-term due to its compatibility with the patient's immune system. Despite over a decade of research, clinical translation of autologous iPSC-based therapies has been slow-partly due to a lacking pre-defined regulatory path. Here, we outline regulatory considerations for developing an autologous iPSC-based product and challenges associated with the clinical manufacturing of autologous iPSCs and their derivatives. These challenges include donor tissue source, reprogramming methods, heterogeneity of differentiated cells, controls for the manufacturing process, and preclinical considerations. A robust manufacturing process with appropriate quality controls and well-informed, prospectively designed preclinical studies provide a path toward successful approval of autologous iPSC-based therapies.
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Registered trials
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.