title: Mesenchymal stromal cell-based therapy: Regulatory and translational aspects in gastroenterology.
abstract: The past decade has witnessed an outstanding scientific production focused towards the possible clinical applications of mesenchymal stromal cells (MSCs) in autoimmune and chronic inflammatory diseases. This raised the need of novel standards to adequately address quality, efficacy and safety issues of this advanced therapy. The development of a streamlined regulation is currently hampered by the complexity of analyzing dynamic biological entities rather than chemicals. Although numerous pieces of evidence show efficacy in reducing intestinal inflammation, some inconsistencies between the mechanisms of action of rodentvshuman MSCs suggest caution before assigning translational value to preclinical studies. Preliminary evidence from clinical trials showed efficacy of MSCs in the treatment of fistulizing Crohn's disease (CD), and preparations of heterologous MSCs for CD treatment are currently tested in ongoing clinical trials. However, safety issues, especially in long-term treatment, still require solid clinical data. In this regard, standardized guidelines for appropriate dosing and methods of infusion could enhance the likelihood to predict more accurately the number of responders and the duration of remission periods. In addition, elucidating MSC mechanisms of action could lead to novel and more reliable formulations such as those derived from the MSCs themselves (e.g., supernatants).
authors.affiliation: Giovanni Dothel, Emanuel Raschi, Roberto Rimondini, Fabrizio De Ponti, Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, I-40126 Bologna, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Dothel
authors.affiliation: Giovanni Dothel, Emanuel Raschi, Roberto Rimondini, Fabrizio De Ponti, Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, I-40126 Bologna, Italy.
authors.forename: Emanuel
authors.initials: E
authors.lastname: Raschi
authors.affiliation: Giovanni Dothel, Emanuel Raschi, Roberto Rimondini, Fabrizio De Ponti, Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, I-40126 Bologna, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Rimondini
authors.affiliation: Giovanni Dothel, Emanuel Raschi, Roberto Rimondini, Fabrizio De Ponti, Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, I-40126 Bologna, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: De Ponti
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000378:metabolism; D005762:Gastroenterology / Q000331:legislation & jurisprudence / Q000379:methods*; D005767:Gastrointestinal Diseases / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000601:surgery*; D033161:Government Regulation; D006291:Health Policy; D006801:Humans; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects / Q000331:legislation & jurisprudence; D059630:Mesenchymal Stem Cells / Q000378:metabolism / Q000502:physiology*; D061214:Patient Safety; D010641:Phenotype; D012038:Regeneration; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence / Q000379:methods*; D012307:Risk Factors; D057170:Translational Research, Biomedical / Q000331:legislation & jurisprudence / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers
keywords: Inflammatory bowel diseases; Intestinal disorders; Mesenchymal stem cells; Mesenchymal stromal cells; Translational medicine