Stem cell transplantation for nervous system disorders in Italy, European Union, and Ukraine: Clinical approach and governmental policies

Siniscalco, Dario; Sych, Nataliia

doi:10.18679/cn11-6030/r.2015.016

Cited by 1 publication

(2 citation statements)

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“…Approved medical treatments including cell therapies will not be fit for this agreement. Many countries and areas such as the United States, India, and Europe 140 , however, are adopting the practice of allowing compassionate use of therapies shown to be safe and with some evidence of efficacy to treat disorders for which there is no known effective therapy. Regulatory agencies will often negotiate with the clinician or company for the patient to pay the cost of the therapy.…”

Section: Provisionsmentioning

confidence: 99%

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Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

et al. 2018

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Cell therapy has been shown to be a key clinical therapeutic option for central nervous system diseases or damage. Standardization of clinical cell therapy procedures is an important task for professional associations devoted to cell therapy. The Chinese Branch of the International Association of Neurorestoratology (IANR) completed the first set of guidelines governing the clinical application of neurorestoration in 2011. The IANR and the Chinese Association of Neurorestoratology (CANR) collaborated to propose the current version “Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)”. The IANR council board members and CANR committee members approved this proposal on September 1, 2016, and recommend it to clinical practitioners of cellular therapy. These guidelines include items of cell type nomenclature, cell quality control, minimal suggested cell doses, patient-informed consent, indications for undergoing cell therapy, contraindications for undergoing cell therapy, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, do not charge patients for unproven therapies, basic principles of cell therapy, and publishing responsibility.

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Section: Provisionsmentioning

confidence: 99%

“…A number of clinical studies concerning cell therapies with a positive outcome have led to the suggestion that combination cell therapies and/or certain transplantation approaches with rehabilitation can be more effective 107 , 123 , 128 – 130 , 136 , 138 – …”

Section: Provisionsmentioning

confidence: 99%