H-CYTE Announces Publication of Additional Data that Further Supports Efficacy of Innovative PRP-PBMC Treatment Aimed at Helping to Improve Overall Lung Health
Study Successfully Met Goal of Statistically Significant Improvement in Pulmonary Function at 3 Months Post-Treatment
TAMPA, Fla., July 06, 2021 (GLOBE NEWSWIRE) -- H-CYTE, Inc. (OTCQB: HCYT), a medical biosciences company focused on the field of regenerative medicine, today announced the publication of new data supporting the safety and efficacy of its innovative autologous treatment in helping improve overall lung health.
Published in the peer reviewed Journal of Regenerative Medicine & Biology Research, the observational study demonstrated statistically significant improvement in pulmonary function (FEV1% predicted) at 3 months and quality of life (CCQ) at 3-6, and 12 months post-treatment for GOLD stage 3 and 4 patients. The study, titled “Platelet Rich Plasma-Platelet Concentrate Therapy in COPD: an Observational Cohort Study,” is available at https://athenaeumpub.com/wp-content/uploads/Platelet-Rich-Plasma-Platelet-Concentrate-Therapy-in-COPD-An-Observational-Cohort-Study.pdf.
The Institutional Review Board (IRB) approved study was conducted in 419 patients* with chronic obstructive pulmonary disease (COPD). Results demonstrated 67% of participants treated with PRP-PBMC experienced either an improvement in their pulmonary lung function or no decline from baseline at 3 months with just one treatment. In addition, the study demonstrated statistically and clinically significant quality of life improvement. 83% of patients saw improvement at 3 months, 78% of patients at 6 months, and 73% of patients at 12 months post-treatment.
Patients remained on any physician prescribed medications for their condition. The most common maintenance treatments for COPD include inhaled corticosteroids, beta-2 agonists, anticholinergics, nebulized albuterol and supplemental oxygen for the duration of the study. All participants tolerated the procedure well, and there were no reportable adverse or unexpected events.
H-CYTE Chief Executive Officer Robert Greif stated, “Today’s positive news is a furtherance of our recent publications showing clinically significant real-world data relating to our autologous treatment aimed at improving lung health. With this additional published peer reviewed study, we add to our growing repository of supportive data, allowing us to better quantify real world results while strengthening the value proposition that we believe our treatments can provide our patients.”
Melissa M. Rubio, PhD, APRN, and certified principal investigator of the study said, “These results are particularly impressive because significant improvements were observed above and beyond what maintenance therapy alone could deliver.” Dr. Rubio added, “The majority of these patients were diagnosed with Stage 4 COPD. The efficacy, safety and quality of life outcomes in this study suggest that cellular therapies should be considered as a safe, valuable, adjunctive therapy in patients with COPD.”
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 randomized, double-blind trial involving the company’s innovative PRP-PBMC therapy is currently being planned.
*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 operates in compliance with CFR Title 21 Part 1271.15 (b) Regulation.
About H-CYTE, Inc.
H-CYTE is a medical biosciences company focused in 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.
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Released July 6, 2021