Industry updates from the field of stem cell research and regenerative medicine in October 2021

Latest developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from nonacademic institutions in October 2021.

Online seminars as an information source for direct-to-consumer stem cell therapy

Aim: To attend stem-cell (SC) seminars hosted by US-based direct-to-consumer SC businesses either in person or via online ‘webinars’ to determine accuracy and regulatory oversight of the advertised SC therapies. Methods: The therapeutic claims, costs, risks, scientific evidence in support of a therapy and any regulatory oversight were collated using pre-established checklists. Participation consisted of one live attendance of a seminar, and following COVID-19 restrictions, review of seven recorded presentations available on the internet from SC businesses. Results & conclusion: None of the SC therapies advertised by direct-to-consumer clinics reviewed were supported by proper clinical evidence nor substantiated by peer reviewed literature.

Photobiomodulation of inflamed dental pulp stem cells under different nutritional conditions

Aim: The present study aimed to investigate photobiomodulation's (PBM) effect on inflamed dental pulp stem cells (IDPSCs) under different nutritional conditions. Methods: Cell proliferation and odontogenic differentiation were evaluated using the MTT assay and real-time quantitative reverse transcription PCR, respectively after laser PBM of cells in 5 or 10% fetal bovine serum (FBS) culture conditions. Results: A significant positive effect of laser irradiation on cell proliferation under both nutritional conditions after 24 and 48 h was observed. DMP-1 gene expression increased in the groups with laser irradiation and 5% FBS. Comparison of gene expression levels in the four groups revealed no statistically significant stimulatory effect. The highest gene expression was observed in the non-laser group with 5% FBS. Conclusion: Further studies are required to obtain an irradiation setup to ideally improve inflamed dental pulp stem cells' proliferation and differentiation.

Adverse events related to unapproved stem cell products and other regenerative interventions: recommendations for more robust regulation of the direct-to-consumer marketplace

Tweetable abstract Adverse events continue to occur in the direct-to-consumer market for unapproved regenerative interventions and US FDA alone cannot adequately address the problem. Other public health strategies are needed to provide better patient protection.

Regenerative medicine and traumatic brain injury: from stem cell to cell-free therapeutic strategies

Traumatic brain injury (TBI) is a serious health concern, yet there is a lack of standardized treatment to combat its long-lasting effects. The objective of the present study was to provide an overview of the limitation of conventional stem cell therapy in the treatment of TBI and to discuss the application of novel acellular therapies and their advanced strategies to enhance the efficacy of stem cells derived therapies in the light of published study data. Moreover, we also discussed the factor to optimize the therapeutic efficiency of stem cell-derived acellular therapy by overcoming the challenges for its clinical translation. Hence, we concluded that acellular therapy possesses the potential to bring a breakthrough in the field of regenerative medicine to treat TBI.

Personalized multitarget biologic injection in the spine: prospective case series of multitarget platelet-rich plasma for low back pain

Aim: To evaluate the use of a multitarget platelet-rich plasma (PRP) injection approach for the treatment of chronic low back pain (LBP). Materials & Methods: Forty-six patients with more than 12 weeks of LBP who failed conservative treatments were injected with PRP into the facet joints, intervertebral discs, epidural space and/or paravertebral muscles. Visual analog pain scale and Roland-Morris Disability Questionnaire scores were measured at baseline and predefined intervals. Results: Mean visual analog pain scale was reduced from 8.48 to 5.17 and mean Roland-Morris Disability Questionnaire from 18.0 to 10.98 at 12 weeks (p < 0.001). These statistically significant improvements were sustained over 52 weeks. No adverse effects were observed. Conclusion: Our PRP approach demonstrated clinically favorable results and may be a promising treatment for chronic LBP.

Experimental study of negative pressure wound therapy combined with platelet-rich fibrin for bone-exposed wounds

Aim: To evaluate the efficacy of negative pressure wound therapy (NPWT) combined with platelet-rich fibrin (PRF) in treating bone-exposed wounds and explore its possible mechanism. Materials & methods: A bone-exposed wound was created in a total of 32 healthy Sprague-Dawley rats, which were treated with either control, NPWT group, PRF group or both (N + P group). The bone-exposed area, skin contraction rate and granulation coverage and the level of growth factors in granulation tissue were determined on days 4, 7 and 10. Results: The N + P group showed significantly higher wound closure rate than that achieved with others respectively. Four factors were significantly higher in N + P group than in the other three groups. Conclusion: Combination of NPWT and PRF can repair bone-exposed wounds effectively and accelerate wound healing.

Creative regulatory practices to develop stem-cell technology: the way forward for Malaysia

Malaysia aspires to develop regenerative medicine through stem-cell technology. It needs a regulatory system that could facilitate development and prevent unethical practices. A comparative legal analysis on the regulation of stem-cell technology, with a focus on stem-cell research in Malaysia and selected Commonwealth countries that are experienced in regulating this complex technology, demonstrates that the selected Commonwealth countries have adopted a hybrid of different regulatory mechanisms. This paper argues that Malaysia should consider adopting a similar approach to equip relevant authorities with different regulatory mechanisms that are able to promote innovation in stem-cell research activities and cultivate a successful and profitable regenerative medicine industry in the future. Such a strategic action can produce an optimal regulatory outcome and help Malaysia to realize its aspiration.

Decellularized bovine aorta as a promising 3D elastin scaffold for vascular tissue engineering applications

Aim: To evaluate the suitability of using aorta elastin scaffold, in combination with human adipose-derived mesenchymal stem cells (hAd-MSCs), as an approach for cardiovascular tissue engineering. Materials & Methods: Human adipose-derived MSCs were seeded on elastin samples of decellularized bovine aorta. The samples were cultured in vitro to investigate the inductive effects of this scaffold on the cells. The results were evaluated using histological, and immunohistochemical methods, as well as MTT assay, DNA content, reverse transcription-PCR and scanning electron microscopy. Results: Histological staining and DNA content confirmed the efficacy of decellularization procedure (82% DNA removal). MTT assay showed the construct’s ability to support cell viability and proliferation. Cell differentiation was confirmed by reverse transcription-PCR and positive immunohistochemistry for alfa smooth muscle actin and von Willebrand. Conclusion: The prepared aortic elastin samples act as a potential scaffold, in combination with MSCs, for applications in cardiovascular tissue engineering. Further experiments in animal models are required to confirm this.