First Decade of Clinical Trials and Published Studies with Mesenchymal Stromal Cells from Umbilical Cord Tissue

Abstract

Aim: This is the first analysis of both clinical trials and published studies that employ umbilical cord mesenchymal stromal cells, for the decade 2007–2017. Materials & methods: Searching international databases, we found 178 registered trials and 98 publications. Results: Among the registered clinical trials, 20% have resulted in publications so far. Among the publications, 18% report safety and 74% report some form of improvement. Between 36 and 45% of the publications do not report aspects of the cell manufacturing, including isolation method, culture medium or number of culture passages. Conclusion: Analyses that link trials with publications can elucidate factors that promote study completion and publication. More full disclosure of cell manufacturing is needed to evaluate the efficacy of mesenchymal stromal cell isolated from umbilical cord tissue (UC-MSC) products.

Mechanisms underlying the protective effects of mesenchymal stem cell-based therapy

“…During the same time, a total of 98 clinical studies were published. Although 74% of the publications reported some promising results, only 18% of the publications showed that this treatment was safe [115]. Although the safety of MSC transplantation was confirmed, less than 40% of the studies and clinical trials with available and published results showed [128] positive improvements in the use of MSCs for patients with amyotrophic lateral sclerosis [116].…”

Use of Human Umbilical Cord and Its Byproducts in Tissue Regeneration

“…Human umbilical cord, compared to other tissues such as bone marrow or fat, is a better source of mesenchymal stem/stromal cells (MSCs), as it is easy to access and readily available in great quantities after birth (Can and Karahuseyinoglu, 2007;Wu et al, 2018). Couto et al (2019) discussed that of 178 HUC-MSCs reported clinical trials, 20% were published. Of these, 18% concluded that MSCs were safe to use, and in 74% of the publications some form of improvement was evidenced.…”

“…Of these, 18% concluded that MSCs were safe to use, and in 74% of the publications some form of improvement was evidenced. Moreover, a representative number of publications did not report essential aspects of the isolation method and culture (Couto et al, 2019). This lack of information challenges consensus and agreements on procedures and key technical features that are crucial for the reproducibility in methodology, and that might influence the therapeutic effect.…”

“…Human umbilical cord-MSCs research is costly, and it is challenging for researchers and health professionals to compare the results from a variety of culture methods in order to conclude on the benefits and to obtain approval from regulatory agencies (Davies et al, 2017;Cameau et al, 2018;Ertl et al, 2018;Couto et al, 2019). The definition of MSCs requires strict criteria; however, accepted protocols for isolation, expansion and cryopreservation vary greatly (Dominici et al, 2006;Mendicino et al, 2014;Galipeau and Krampera, 2015).…”

“…HUC byproducts, such as cells and extracts, have been studied in vitro and in vivo with encouraging results in tissue outcomes (Iftimia-Mander et al, 2013;Papanna et al, 2015b;Wu et al, 2018). HUC Mesenchymal Stem Cells (MSCs), especially those isolated from the Wharton's Jelly (WJ), are already being used in clinical trials which have reported safety and efficacy in wound healing (Couto et al, 2019). HUC patches have been used in clinical practice with proven reparative effects for gastroschisis, and in preclinical assays for spina bifida and foot ulcers (Hernández Siverio et al, 2007;Papanna et al, 2015b;Caputo et al, 2016).…”