Informed Consent Guidelines for Optimizing the Use of Telomerase-Positive Stem Cells

Informed Consent Guidelines for Optimizing the Use of Telomerase-Positive Stem Cells
Henry E Young, Mark O Speight
Journal of Regenerative Medicine & Biology Research, 22 July 2020
Open Access
Abstract
The objectives of the work, based on previous characterization studies, pre-clinical animal models of induced diseases, e.g., Parkinson disease, cardiovascular disease, pulmonary disease, and type-I diabetes mellitus, and early clinical human studies of Parkinson disease, cardiovascular disease, and pulmonary diseases, were to established a set of criteria that needed to be followed for using telomerase-positive stem cells in future human clinical trials. From this set of criteria, informed consent guidelines were established to optimize the safety and efficacy of using endogenous adult-derived telomerase-positive stem cells to restore organ function by either repair and/or regeneration of cells and tissues resulting from tissue damage and/or loss. Inclusion criteria were any male or female, 18 to 120 years of age, with preferably no serious comorbidities. Exclusion criteria were use of alcohol, tobacco products, vaping, recreational drugs, lidocaine, and/or chemotherapeutic drugs. We also cautioned use of caffeine and corticosteroids, as well as limiting moderate to strenuous physical activity within a two week window before and after stem cell treatment. Following these inclusion and exclusion criteria, endogenous adult-derived autologous and/or allogeneic telomerase-positive stem cells have proven to be both safe and effective at restoring (up to 50% above pre-treatment values in compliant individuals) organ function for diseases and/or disorders caused by trauma or chronic diseases. Conditions treated thus far, within IRB-approved human study protocols, include neurodegenerative, cardiovascular, pulmonary, autoimmune, renal, and orthopedic disorders.

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