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Adult Stem Cells for Intervertebral Disc Repair
Published in Raquel M. Gonçalves, Mário Adolfo Barbosa, Gene and Cell Delivery for Intervertebral Disc Degeneration, 2018
Esther Potier, Delphine Logeart-Avramoglou
The utility of allogeneic adult stem cells remains an intense area of investigation due to their advantages over autologous stem cells with regard to time, cost, and quality assurance (Zhang et al. 2015). Two completed (#NCT01290367 and #NCT01860417) and two ongoing (#NCT02529566 and #NCT02412735) clinical trials have been conducted for evaluating the effects of allogenic BM-MSCs. Notably, a phase 2 clinical trial study on 100 patients assessed the potency of allogenic mesenchymal precursor cells (MPCs) (Mesoblast, Melbourne, Australia), commercially available cells derived from specific STRO-3 positive selected BM-MSC population, which has been demonstrated to possess a higher proliferation capacity, higher expression levels of early stem cell markers, and tri-lineage differentiation potential (See et al. 2011). The trial results showed that 41% and 35% of patients who received 6 and 18 million MPCs, respectively, reached target criteria for treatment success (i.e., a 50% reduction in the pain score and a 15-point reduction in the Oswestry disability index) after 24 months. In comparison, only 18% and 13% of the patients treated with hyaluronic acid or saline reached these criteria, respectively (Mesoblast Inc. 2017). These promising outcomes have supported an ongoing 360-patient phase 3 trial, making it the largest human IVD cell-based therapy study (#NCT02412735).
The Effect of Adipose-Derived Stromal Vascular Fraction Cells to Abdominal Wall Fascia Defects in Rats: An Experimental Study
Published in Journal of Investigative Surgery, 2022
Elif Tuncay, Ozan Akinci, Asiye Perek, Esin Aktas Cetin, Nuray Kepil, Murat Toksoy, Nurdan Altan
Stem cells are capable of self-renewal and can differentiate into many types of cells and turn into mature differentiated cells. Adipose tissue offers a rich and accessible reserve of multipotent adult stem cells for tissue engineering and regenerative medicine. Stromal vascular fraction (SVF), obtained through the enzymatic digestion of lipectomy material with collagenase, consists of mesenchymal stem cells. Adipose-derived mesenchymal stromal cells (AD-MSCs), originating from mesoblast cells, are multipotent and can differentiate into many types of cells, such as adipocytes, chondrocytes, osteoblasts, and myocytes [5]. A multipotent stem cell can be derived from various sources, such as bone marrow or umbilical cord blood. However, due to the difficulty in derivation and ethical concerns about multiple stem cells, accessing AD-MSCs is an easier, more convenient, and more cost-effective method [6–8].
Mesenchymal stromal cell based therapies for the treatment of immune disorders: recent milestones and future challenges
Published in Expert Opinion on Drug Delivery, 2020
Ainhoa Gonzalez-Pujana, Manoli Igartua, Edorta Santos-Vizcaino, Rosa Maria Hernandez
In 2009, Osiris Therapeutics conducted the first major phase III clinical trial with MSCs (NCT00366145). This randomized, double blind, placebo-controlled study was focused on the evaluation of the efficacy and safety of their product, Prochymal®. It consisted of allogeneic BMMSCs and was intended for the treatment of steroid-refractory GvHD. Despite this study failed to demonstrate efficacy, since the primary endpoint of the study did not significantly improve in comparison to the placebo group [113], it represented an important starting point for future trials. In particular, a retrospective analysis of the results, severely criticized in the field, showed improvement in pediatric patients. In 2013, Prochymal® assets were divested to Mesoblast Inc., which based on such analyses, conducted the adaptive prospective clinical trial for pediatric steroid-refractory GvHD (NCT02336230), naming the product Remestemcel-L®. In 2018, a press release announced that the study had met the primary endpoint and improved the overall response (with a 69% of subjects responding to Remestemcel-L® in comparison to the protocol-defined control rate of 45%). Some authors claim that these successful results might lead to the first FDA approved MSC product in the USA [110]. On the other hand, the therapy has been approved in Canada for pediatric GvHD, but via notice of compliance with conditions (NOC/c) [110]. Moreover, on September 2015, Mesoblast’s licensee JCR Pharmaceutical Co. Ltd. received the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval for their product TemCell® in the treatment of severe GvHD [114].