Title: The regener age combinatorial bio-interventions using bioquantine® and allogeneic mesenchymal Stem Cells combined with a spinal cord stimulation system in a No Option patient with ASIA-A classification

Biography:

Joel Isaias Osorio Garcia is MD, CEO and Founder of Biotechnology and Regenerative Medicine at RegenerAge™. (www.regenerage.clinic). Vice President of International Clinical Development for Bioquark, Inc. (www.bioquark.com) and Founder and president for the Dr. Jois A.C initiative (www.drjois.com). Advance Fellow by the American Board of Anti-Aging and Regenerative Medicine (A4M), Visiting Scholar at University of North Carolina at Chapel Hill (Dermatology). Fellow in Stem Cell Medicine by the American Academy of Anti-Aging Medicine and University of South Florida.

Abstract

In 1973 the American Spinal Injury Association made the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). In this clinical review our patient was classified after the vertebral fixation surgery with a ASIA-A scale injury after suffering a fracture and luxation at T-12-L1, having total spinal cord section (Fig.A). Based on the research made by Sergei Paylian, PhD on animal models [1] and the safety use of allogeneic MSCs demonstrated on multiple animal models applications [11,12], we decided to apply a experimental translational medical protocol based the research and the previous outcomes obtained by Hamid and MacEwan [8,9] and decided to customize it exclusively to our patient based on the clinical evidence and personalizing the therapy on evidence. The medical team designed an ambulatory method utilizing a C-arm to apply the allogeneic MSCs in situ and using a intrathecal (subdural) catheter using a slow pump release system for the rest of the biological material with an optimum tolerance and minor side effects (mild fever, miyalgias and headache) on the first 48hrs hour after application. The experimental use of mRNA Bioquantine® was well tolerated with its purified form (intra and extra-oocyte liquid phases of electroporated oocytes [6]) showing to be well tolerated by the patient without any anaphylactic reaction. The current clinical report is meant to demonstrate the beneficial changes with the use of Bioquantine® and its administration in a patient with a severe SCI offering a possible optional therapy and potential neuroregeneration in this clinical condition. Mesenchymal stem cells (MSCs) are ideal for cell-based therapy in various inflammatory diseases because of their immunosuppressive and tissue repair properties. Moreover, their immunosuppressive properties and low immunogenicity contribute

to a reduced or weakened immune response elicited by the implantation of allogeneic MSCs compared with other cell types, allogeneic MSCs are a promising option because of their low immunogenicity and immunosuppressive and tissue repair capabilities. The positive findings throughout the evolution of our protocol for spinal cord injury with the obtained results at this stage is a promising scientific based and evidence based medicine protocol that can be offered in the near future as an option for severe SCI patients. The functionality of the RestoreSensor® SureScan® by providing the electric stimulation fortifies the medical outcome and has given the patient the confidence to perform his physical rehabilitation with more energy for a longer time by the increase or decrease of the intensity of it according to the type of exercise regulated by the control-battery he handles. At this date, after 8 intrathecal applications of allogeneic MSCs and Bioquantine® in situ combined together we have got the following outcomes: an improvement in sensitivity, strength in striated muscle and smooth muscle connection by increased muscle mass (Fig.B) and sphincter

control, at 23 months after the first regenerative therapy and 12 months after the placement of RestoreSensor® the patient is showing an evident improvement on his therapy of physical rehabilitation (legs movement and control of them) having the following movements reported by the physical therapist: a)hip: adduction and external rotation, extension, abduction, internal rotation; b)knee: flexion; c)toe: MP and IP extension, also reporting an easier and functional crawling forward and backwards, and since 3 months ago the patient is capable to stand on his knees for 2 or more minutes without any support (Fig. C) and taking small steps on his knees forward and backwards for the first time in his process, showing a progressively important functionality on both limbs, voluntary movement at both feet and an increase in sensory perception.