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

Abstract

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.

Wharton’s Jelly-Derived Mesenchymal Stem Cell Transplantation in a Patient with Hypoxic-Ischemic Encephalopathy

“…Notably, implantation of human MSCs, even though a limited number of the cells engrafted, can stimulate proliferation, migration, and differentiation of the host endogenous neural stem cells via paracrine beneficial growth factors 36 . On the other hand, regardless of the potentcy of MSCs’ paracrine effect, our application doses (1×10 6 /kg for each application route) are consistent with the current literature as previously mentioned 16 , 19 , 41 .…”

“…Also, we did not track the WJ-MSCs in our patient after transplantation, which however remains technically difficult in clinical trials. Notably, there is currently no consensus regarding the cell culture condition, optimal dose, route, and duration of administration; these are parameters that need to be researched in depth in order to provide better guidance about the next step to follow in WJ-MSCs treatment 16 , 36 , 42 .…”

Neural stem cell derived extracellular vesicles: Attributes and prospects for treating neurodegenerative disorders

“…NSCs expanded derived from the fetal, postnatal and the adult brain, as well as ESCs and iPSCs, have therapeutic properties, which are evident from numerous studies employing grafting of NSCs into the aged brain and the adult brain afflicted with injury or disease. [4,36,42,43,45,94,96,101,109] The beneficial effects of NSC graft appear to be mainly mediated through enhancement of regeneration, plasticity and neurogenesis, and attenuation of neuroinflammation. [13,54,88] Indeed, several clinical trials are currently progressing in different phases.…”

Stem cell therapy in autism: recent insights

“… 95 These guidelines issue the recommended standards for personnel, facilities, and institutions that perform cell-based therapies, as well as the ethical requirements, and include the provisions: patient-informed consent/IRB; indications/contraindications for cell therapy; documentation of procedure and therapy; safety and efficacy evaluations; policy of repeated treatments; not charging patients for unproven therapies; basic principles of cell therapy; and publishing responsibility. 95 While the mechanisms of action of stem cells are being explained by basic research, as well as by in vivo models, clinical trials provide scientific effectiveness for human applications. 96 However, from the clinical trials examined above ( Table 2 ), several limitations have to be taken into account, before claiming definitive results for the use of stem cells in ASD treatment.…”