ReviewMolecular aspects of medicine2023
The evolving regulatory landscape in regenerative medicine.
Review in Molecular aspects of medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
33 citing papers in PubMed.
- Three-Dimensional Bioprinting in Reconstructive Plastic Surgery: A Comprehensive Review.Cells · 2026Review
- Availability and Pricing of Orthobiologic Knee Injections Vary by Practice Type but Not by Community Socioeconomic Vulnerability in Suburban New York.Arthroscopy, sports medicine, and rehabilitation · 2026Article
- Allogeneic islet products for type 1 diabetes: Navigating nonclinical and manufacturing regulatory expectations.Stem cell reports · 2026Review
- Biobanked Liver Organoids: A Roadmap for Precision Hepatology.BioEssays : news and reviews in molecular, cellular and developmental biology · 2026Review
- Silk-Derived 3D-Bioprinted Scaffolds for Neural Repair and Nerve Regeneration: A Comprehensive Review.Life (Basel, Switzerland) · 2026Review
- Artificial Intelligence Across the Drug Development Lifecycle.Medical sciences (Basel, Switzerland) · 2026Review
- Making Advanced Therapies Affordable and Accessible: Two Strategic Approaches.Developing world bioethics · 2026Article
- Therapeutic Potential of Extracellular Vesicles: From Biogenesis, Isolation and Molecular Characterization to Addressing Translational Gaps and Regulatory Barriers.International journal of molecular sciences · 2026Review
- Stem cell dysfunction and rejuvenation strategies in ageing: emerging advances in regenerative medicine.Frontiers in cell and developmental biology · 2026Review
- A Reliability Tier Classification System (RTCS) for Marketed Exosome-Based Products to Facilitate Clinical Decision-Making.Clinical, cosmetic and investigational dermatology · 2026Article
- Autophagy and mitophagy at the synapse and beyond: implications for learning, memory and neurological disorders.Autophagy · 2026Review
- Article
- Promises and Pitfalls of Regenerative Therapies for Androgenetic Alopecia: Platelet-Rich Plasma, Photobiomodulation, Stem Cells, and Exosomes.Medical sciences (Basel, Switzerland) · 2025Review
- Stem Cell-Based Cancer Therapies: A Commentary on Therapeutic Promise, Health Impacts and Translational Barriers.Cancer innovation · 2025Article
- Current landscape of US Food and Drug Administration use of expedited regulatory approvals for colorectal cancer care.Journal of managed care & specialty pharmacy · 2025Article
- Review
- Neuroangiogenesis potential of mesenchymal stem cell extracellular vesicles in ischemic stroke conditions.Cell communication and signaling : CCS · 2025Review
- Therapeutic Potential of Extracellular Vesicles in Oral Inflammation.International journal of molecular sciences · 2025Review
- Extracellular vesicles in cancer´s communication: messages we can read and how to answer.Molecular cancer · 2025Review
- Repairing Effect and Mechanism of the 4-Dimensionally Printed Limbal Stem Cell Strategy on Corneal Alkali Burns in Large Animals.Biomaterials research · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
Regenerative medicine as a field has emerged as a new component of modern medicine and medical research that encompasses a wide range of products including cellular and acellular therapies. As this new field emerged, regulatory agencies like the Food and Drug Administration (FDA) rapidly adapted existing regulatory frameworks to address the transplantation, gene therapy, cell-based therapeutics, and acellular biologics that fall under the broader regenerative medicine umbrella. Where it has not been possible to modify existing regulation and processes, entirely new frameworks have been generated with the intention of providing flexible, forward-facing systems to regulate this rapidly growing field. This review discusses the current state of FDA regulatory affairs in the context of stem cells and extracellular vesicles by highlighting gaps in the current regulatory system and then discussing where regulatory science in regenerative medicine may be headed based on these gaps and the FDA's historical ability to deal with emerging fields. Lastly, we utilize case studies in stem cell and acellular based treatments to demonstrate how regulatory science has evolved in regenerative medicine and highlight the ongoing clinical efforts and challenges of these therapies.
Indexed as
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What OpenQuestion holds
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.