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Statistically Significant Improvement in Pulmonary Function at Both 3 Months and 12 Months Post Treatment
TAMPA, Fla., June 29, 2021 (GLOBE NEWSWIRE) -- H-CYTE, Inc. (OTCQB: HCYT), a medical biosciences company focused on the field of regenerative medicine, today announced the publication of its clinical observational study titled, “Longitudinal Assessment of FEV1 Change Following Autologous Cellular Therapy.”
The study, published in the peer-reviewed Journal of Regenerative Medicine & Biology Research, relates to the Company’s innovative autologous treatment, and concludes that patients experienced a statistically significant improvement in pulmonary function at both 3 months and 12 months (FEV1 % predicted) and quality of life (CCQ score) post treatment. The study may be accessed at https://athenaeumpub.com/longitudinal-assessment-of-fev1-change-following-autologous-cellular-therapy/.
Robert Greif, H-CYTE Chief Executive Officer stated, “I’m pleased to announce the publishing of this clinically significant real-world data relating to our autologous treatment aimed at improving lung health. In the past and prior to my joining the Company, we believed patients were seeing meaningful improvement in lung function, but we were not in the position to quantify that improvement. With the publishing of this peer reviewed study, we gain tangible data, strengthening the underlying foundation of our current operations, while allowing us to better compose and execute our strategy going forward. We look forward to leveraging this positive data, along with more expected to come, to build sustainable shareholder value. The field of regenerative medicine has immense promise to help transform the current healthcare landscape and offers the potential for new adjunctive care for chronic disorders which continue to increase in prevalence and mortality.”
The study, which involved 281 participants with COPD (chronic obstructive pulmonary disease). demonstrated that 23% of patients saw an improvement in their lung function by at least 15% from baseline at 3 months post-treatment (FEV1 measures), and 29% of patients saw the same improvement at 12 months post-treatment. At 3 months and 12 months post-treatment, 64% and 67% of participants respectively, experienced a significant quality of life improvement. All participants tolerated the procedure well, and there were no reportable adverse or unexpected events. All participants were able to stay on their physician prescribed medications to manage their COPD. The efficacy, quality of life and safety shown in this study were above and beyond that achieved with their maintenance therapy.
Melissa M. Rubio, PhD, APRN, and certified principal investigator of the study, said, “These findings are particularly important because they suggest that this therapy may help slow or prevent the typical, expected progression of COPD. The duration of treatment effect is especially impressive.”
The data came from an externally validated patient database. The study design was observational following the intervention and therefore the limitations due to lack of a control group are recognized. To address this, a double blind randomized controlled trial involving the Company’s innovative PRP-PBMC therapy is currently being planned.
About H-CYTE, Inc.
H-CYTE is a medical biosciences company focused on the field of regenerative medicine. H-CYTE’s mission is to become a leader in next-generation, cellular therapeutics for the treatment of chronic health conditions, with the ultimate goal of improving patient lives. For more information about H-CYTE, please visit www.HCYTE.com.
Safe Harbor Statement
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While H-CYTE believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those outlined in H-CYTE’s filings with the SEC, including but not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. H-CYTE expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Each patient is different, and results may vary. These statements have not been evaluated by the Food and Drug Administration. This information is not intended to suggest diagnosis, treatment, cure, or prevention of any disease.
H-CYTE Investor Relations
*Each patient is different, and results may vary. These statements have not been evaluated by the Food and Drug Administration. This information is not intended to suggest diagnosis, treatment, cure, or prevention of any disease