ReviewClinical and experimental medicine2014
Regulatory considerations in production of a cell therapy medicinal product in Europe to clinical research.
Review in Clinical and experimental medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Bone Regeneration with Mesenchymal Stem Cells in Scaffolds: Systematic Review of Human Clinical Trials.Stem cell reviews and reports · 2024Pooled it
- How to establish infrastructures to achieve more efficient regenerative medicine?Cell and tissue banking · 2023Review
- Article
- Expansion and characterization of bone marrow derived human mesenchymal stromal cells in serum-free conditions.Scientific reports · 2021Article
- Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges.Pharmaceutics · 2019Review
- Stability enhancement of clinical grade multipotent mesenchymal stromal cell-based products.Journal of translational medicine · 2018Article
- [Advanced medicinal products medical therapy based on mesenchymal stem cells].Farmacja polska · 2018Article
- Clinical research skills development program in cell-based regenerative medicine.Stem cells translational medicine · 2015Article
- Stem cell bioprocess engineering towards cGMP production and clinical applications.Cytotechnology · 2014Article
- Standard requirement of a microbiological quality control program for the manufacture of human mesenchymal stem cells for clinical use.Stem cells and development · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The development of new drugs using stem cells has become a clinic alternative for the treatment of different diseases such as Alzheimer's, diabetes and myocardial infarction. Similar to conventional medicines, stem cells as new medicinal products for cell therapy are subjected to current legislation concerning their manufacture process. Besides, their legality is determined by the Regulatory Agencies belonging to the Member State of the European Union in which they are being registered. With the evolution of therapy that uses cells as medicines, there is a need to develop the appropriate legislative and regulatory framework capable of ensuring their safety and effectiveness. However, few works have been published regarding the regulations that these products must comply through production and commercialization processes. The present work is focused on the description of key events during clinical development and cell production of stem cells as drugs. Such as the regulations, requirements and directives involved in the production of cell therapy medicinal products, from the clinical design stage to its commercialization in Europe.
Indexed as
Identifiers
23014774What 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.