Proof-of-Concept Trial of an Amniotic Fluid-Derived Extracellular Vesicle Biologic for Treating High Risk Patients with Mild-to-Moderate Acute COVID-19 Infection
Organicell’s latest research publication is now available to read in Biomaterials and Biosystems Journal, “Proof-of-Concept Trial of an Amniotic Fluid-Derived Extracellular Vesicle Biologic for Treating High Risk Patients with Mild-to-Moderate Acute COVID-19 Infection”.
We have dedicated this to our Primary Investigator who didn’t have the chance to see it published. Thank you Dr. Friedewald, your career has greatly impacted us and has left us inspired to continue your legacy.
https://organicell.com/wp-content/uploads/2021/12/Biomaterials_WebBanner-scaled.jpg16002560Organicellhttps://organicell.com/wp-content/uploads/2022/08/organicell.svgOrganicell2021-12-06 14:20:392021-12-07 12:08:52Proof-of-Concept Trial of an Amniotic Fluid-Derived Extracellular Vesicle Biologic for Treating High Risk Patients with Mild-to-Moderate Acute COVID-19 Infection
From 2003 through November 2015, Mr. Bothwell served in various executive positions for Central Energy GP LLC, the general partner of Central Energy Partners LP, a publicly traded master limited partnership.
From July 2007 through November 2015, Mr. Bothwell served as President and a director of Regional Enterprises, Inc. Since April 2007, Mr. Bothwell has served as the President and controlling member of Rover Technologies, LLC, a company formed to provide management solutions to the public transportation industry. Since 2015, Mr. Bothwell has also served as the President and controlling member of CountOnMe Inc., a company that provides software solutions for the educational industry. Mr. Bothwell received his Bachelor of Science in Business Administration from Boston University in 1984.
Ivan Santos
Ivan Santos is the Biologics Manufacturing and Operations Manager at Organicell. Experienced in regenerative medicine, Ivan has a strong ability to translate design requirements into actionable plans. He brings valuable experience in biotechnology and neuroscience research, and is a key contributor to the development of novel therapeutics at Organicell.
Ivan is immensely adept with biologic quantification techniques such as ELISA assays, bradford analysis, flow cytometry, nanosight technology, and is skilled in biologic processing such as exosome isolation, and cell culturing and expansion.
He also has extensive experience with MATLAB/Simulink, Wolfram Mathematics, and Python, contributing qualitative analysis programing to biologic research and manufacturing.
SKILLS INCLUDE:
ELISA/Bradford/Flow Cytometry/Nano sight
MSCs Cell Culture/Exosomes Isolation
Quality Assurance/Validation
Extensive experience in MATLAB/Simulink, Wolfram Matematica, Python
Albert Mitrani
Mr. Mitrani serves as the Executive VP of Sales, Co-Founder and Board Member at Organicell Regenerative Medicine, Inc. He formerly served as the Chairman of the Board, Chief Executive Officer, Secretary and Treasurer at Organicell Regenerative Medicine, Inc. (alternate name Biotech Products since June 24, 2011). Mr. Mitrani formerly served as the Chief Executive Officer, President and Director of Analytical Stem Cell Corp. from April 2014 to May 2015. From February 2012 to March 2014, Mr. Mitrani served as the Chief Executive Officer of Americell Trinidad and the President of ASCAAC LLC (American Stem Cell) from March 2011 to January 2013. Mr. Mitrani served as the Chief Executive Officer of American Cellular Center in Quito Ecuador from 2009 through 2012.
HIS SPECIALTIES INCLUDE:
Proven achievement in fundraising for Regenerative based companies.
Proven achievement in opening medical clinics in developing countries.
Proven achievement in entrepreneurial endeavors of new concepts.
Owner of numerous successful businesses utilizing retail and cable television sales channels.
Experienced manager of daily operations to maximize revenues and gain market share.
Regenerative Medicine
Stem Cell Therapeutics
Exosome Therapeutics
Radio Frequency and Microcurrent Therapeutics
Marketing: Excellent knowledge of retail and direct to consumer sales channels.Consistently provenability to design and direct marketing campaigns leading to increased gross sales, increased market share and reduced cost-of-sales. Image, brand development and market positioning.
Operations: Sound business judgment with strong focus on improving performance. Troubleshooting actual and potential problem areas andimplementing viable solutions that are both profitable and efficient.
Product Management: Involved in all phases of development for product lines from conception to distribution ensuring completion within budget and meeting deadlines.
EDUCATION
CW Post Long Island University
Bachelor of Arts Bachelor of Science, Business Management
PANAMERICAN SCHOOL OF NATURAL MEDICINE
Nevis, West Indies Doctor of Naturopathy
WORLD ORGANIZATION OF NATURAL MEDICINE PRACTITIONERS
Nevis, West Indies Doctor of Natural Medicine
ACCOLADES
Grand Prior, The Sovereign Medical Order of the Knights Hospitaller
Papal Knight, Order. St Sylvester
Awarded Papal Knight from Cardinal Bertone Secretary of State at the Vatican
Maria Ines Mitrani, M.D., PhD
Dr. Maria Ines “Mari” Mitrani is the Chief Science Officer and co-founder of Organicell Regenerative Medicine. For the past 13 years, Dr. Mitrani has led Organicell in developing innovative treatments to various health conditions. She was most recently recognized as one of the ‘Top 100 Healthcare Leaders’ by IFAH for her work spearheading COVID-19 therapeutics. Over the past few years, Dr. Mitrani has built a team of forward-thinking scientists and researchers and has received several FDA approvals to conduct clinical trials; these include COVID-19 acute and Long Hauler sequelae, Chronic Obstructive Pulmonary Disease, and Knee Osteoarthritis.
HER ADVANCED TRAINING INCLUDES:
Stem Cell Science
Stem Cell Treatments
Perinatal Laboratory Processing Techniques
Anti-Aging Treatments
EDUCATION
Dr. Mitrani graduated from the Universidad San Francisco de Quito with an MD and her Ph.D. from S.O.M.A. (Medical Society of Natural Therapies), She received her Doctor of Acupuncture from the Panamerican University of Natural Medicine.
Joseph Rogers
Joseph Rogers is a recent graduate from the Biomedical Engineering Master’s program at the University of Miami. He has over two years of clinical experience and over a year of research experience, including subjects related to neurological disorders and diseases.
ADVANCED TRAINING INCLUDES:
Medical product development
iPS cell research
Physical Therapy
Lumbar and cervical injuries
Post-op patient training
Biodex testing
DNA and RNA extraction
Immunocytochemistry
Plasmid construction
EDUCATION
Joseph is a graduate of the University of Miami, where he received his bachelor of science in Biology with a minor in Chemistry. He received his master of science in biomedical engineering with a focus on tissue design from the University of Miami in 2020.
Tania del Rivero, Ph.D.
Tania del Rivero, Ph.D. is a highly analytical research scientist with over 12 years of experience working in biomedical research. Her field of expertise includes molecular biology, immunology, and neuroscience.
Tania has worked in numerous settings, including both clinical and laboratory settings. She has overseen multiple clinical research projects from residents and faculty at Aventura Hospital and Kendall Regional Medical Center in Miami, FL. Additionally, she has worked in various research laboratories to develop novel drugs and study their biological effects in cell culture and animal models.
Dr. del Rivero earned her doctorate from Drexel University, where her thesis focused on the role of tumor necrosis factor in neuropathic pain. She has also authored numerous publications covering subjects such as osteoporosis, osteomyelitis, spinal cord injury, and neuropathic pain.
ADVANCED TRAINING INCLUDES:
Developing cell culture models
Flow cytometry
Exosome isolation and quantification
RNA extraction, qPCR
ELISAs and Multiplex Immunoassays
EDUCATION
Dr. del Rivero earned her bachelor of science in neuroscience and behavioral biology in 2010 from Emory University in Atlanta, GA, where she graduated summa cum laude. In 2017, she graduated from Drexel University in Philadelphia, PA, with her doctorate in biology.
AWARDS
Induction to Neuroscience and Behavioral Biology Honors Research Program
Travel Award for CISAB (Center for the Integrative Study of Animal Behavior) Conference — Honorable Mention for best Oral Presentation at CISAB Conference
Induction ro AAAS/Science Program for Excellence in Science
Sheila and David Fuente Neuropathic Pain Research Program Graduate Fellowship
Neuroscience Scholars Program Associate-Society for Neuroscience
Keynote Speaker for Drexel University Spinal Cord Injury Symposium
Drexel Biology Department Travel Award
Member of Consortium for Excellence in Medical Education (CEME) Board of Directors
Cassie Bennett, Ph.D.
Dr. Cassie Bennett holds her doctorate in biomedical engineering. She focuses in research, development, and project management within biomedical environments. Her accomplished work has led her to author and co-author numerous peer-reviewed papers, as well as several poster conference presentations. Dr. Bennett received her doctorate from The University of Miami, during which time she worked as a research assistant and lab manager until her graduation. After graduating, she joined the Organicell team to oversee quality control, the development of standard operating procedures, and quality assurance at the biomedical level.
ADVANCED TRAINING INCLUDES:
Biomedical Engineering
Gene Expression
Immunochemistry
Tissue & Blood Processing
Cell Work
Lab Management
Research
Scientific Publication
Medical & Technical Writing
EDUCATION
Dr. Bennett received her Bachelor of Science in Biological Engineering from Mississippi State University in 2016. In 2021, she graduated with her doctorate in Biomedical Engineering from The University of Miami.
BOARD AFFILIATIONS AND CERTIFICATIONS
Society Of Neuroscience | Member
American Medical Writers Association | Member
Six Sigma | Green Belt Certified
Michael A. Bellio, Ph.D.
As the Laboratory Director at Organicell Regenerative Medicine, I have lead the research, development, and manufacturing of novel biological medicine for the treatment of pulmonary, cardiovascular, and orthopedic degenerative disease. Our teams mission is to advance biological medicine to offer safe and effective solutions to treat diseases. I received comprehensive training manufacturing, characterizing, and culturing primary stem cells and cell derived nanoparticles and exosomes for research, pre-clinical, and clinical regenerative medicine application at the University of Miami’s Interdisciplinary Stem Cell Institute (ISCI). This experience includes the translation of molecular biology techniques including, flow cytometry analysis, protein and RNA analysis, and fluorescence microscopy to the completion of research development and processing validation tasks required in an expanding cGMP production facility. My past research has focused on the develop of in vitro culture systems that modulate physiological levels of oxygen to better isolate and expand potent cell products for use in translational and clinical projects. More recently, I have developed a methodology for the large-scale manufacturing of exosome products from bioreactors for use in translational and pre-clinical research and presented the results at the 2019 International Society of Cell Therapy meeting as a young professional abstract awardee.
EDUCATION/TRAINING:
Sacred Heart University
B.S. – Biology
University of Miami- Miller School of Medicine
Ph.D. – Molecular and Cellular Pharmacology
University of Miami- Interdisciplinary Stem Cell Institute
Post-Doc – Clinical Cell Manufacturing
Julian Milberg
Julian Milberg’s background and training are in the field of engineering, specifically Biomedical Engineering. His skill and expertise in highly evolved
equipment have proven to be a major asset to the industry. He has worked with the Leica Confocal and a Leica TCS SP8 Stimulated Emission Depletion (STED) imaging modality and has instructed engineering students on the proper use and maintenance of a scanning electron microscope. His current work with Organicell in the field of Nanotechnology, specifically with the
Nano Sight NS 300 is helping the industry in looking into the field of virus and vaccine development, gene therapy, and drug delivery systems. In addition to his instructional experience, Mr. Milberg has published technical articles concerning cancer treatment.
HIS ADVANCED TRAINING INCLUDES:
Analysis of Amniotic Fluid
Scanning Electron Microscopy
Robotics
Computer Systems
Testing of Biomedical Equipment
EDUCATION
Mr. Milberg graduated from The University of Miami, School of Engineering after obtaining a BS in Biomedical Engineering and then his Master’s Degree in the field.
BOARD AFFILIATIONS AND CERTIFICATIONS
Microsoft Office Suite Certified
CITI Animal Care and Use
Practical Radiologic Technologist
Basics of Extracellular Vesicles
Fluent in German and Conversant in Spanish
Danique Stewart
As Quality Assurance Associate Danique is responsible for the development and implementation of Organicell™’s Quality Management System. Additionally, she reviews and audits the Standard Operation Procedures for Organicell™ ensuring good manufacturing practices (GMP) are met and exceeded. Experienced in laboratory management Danique brings a wealth of knowledge to her role.
EDUCATION
Danique holds a Bachelor of Science in Biomedical Engineering from Florida International University. She also graduated with honors from Miami Dade College (MDC) with an Associates of Arts in Biology
RESPONSIBILITIES
Development and Implementation of Organicell Quality Management System
Review and Audit of Standard Operating Procedures for Organicell Manufacturing Laboratory
Implementation of GMP standards within Organicell Laboratory
Batch Record Review and Release
Semi-Annual Audits of Organicell Quality Management System
Continual update of Organicell Laboratory’s Quality System based on rules and regulations outlined in FDA Code of Federal Regulations (CFR).
Zanub Abdullah
Zanub is a Cell Processing Specialist at Organicell Regenerative Medicine and brings close to four years of professional experience in medical, manufacturing, quality assurance, regulatory and service environments. She is proficient in FDA rules, regulations, and current good manufacturing practices (cGMP) for research and clinical manufacturing.
RESPONSIBILITIES:
Process extracellular vesicles and perinatal-derived nanoparticles to create therapies for patients following strict FDA guidelines.
Write and revise Standard Operation Procedures (SOPs).
Responsible for laboratory maintenance, reagent receipt and inspection, data entry and analysis, stocking of supplies, and day to day functions of the laboratory.
Responsible for placing all laboratory orders and returns.
Process, store, and release therapies for clincal trails and emergency INDs.
George Shapiro, M.D., F.A.C.C.
Dr. Shapiro has been a practicing physician for 30 years, specializing in Internal Medicine, Cardiovascular Disease and Age Management Medicine. His career in medicine began in 1988 when he graduated from New York Medical College. An internship and residency then followed at Albert Einstein College of Medicine, after which Dr. Shapiro completed a fellowship at Columbia University College of Physicians and Surgeons in 1994, focusing on Cardiovascular Disease Management, including Congestive Heart Failure and Heart Transplantation.
Dr. Shapiro was the recipient of the 10th Annual Alan P. Mintz, M.D. Award, for Clinical Excellence in Age Management Medicine, as he has become known nationwide as an expert in age management medicine, and leads one of the most prominent age management practices in the country as president of Cenegenics New York City.
Always challenged by the need for innovative medicine, Dr. Shapiro has patented medical devices as well as explored and innovated new medical protocols. He has long been known as one of New York’s foremost cardiologists, specializing in regenerative medicine and improving longevity, including the genomics of cardiovascular disease and congestive heart failure.
Dr. Shapiro is active in 13 medical societies, has been a speaker for the Age Management Medicine Group (AMMG) group for many years, and is a long-standing member of the AMMG Conference Planning Committee. Dr. Shapiro was named 2016-2020 Top Doctor in New York City.
Larry Ziff
Larry Ziff has more than 33 years of experience serving the insurance industry. He is recognized as an innovator who brought life insurance to the banking industry by starting the first division of insurance at United Jersey Bank. In addition to being one of the first people to bring life insurance into banks, it should be noted that he has also introduced the world of accounting firms into the life insurance business, and was one of the first people to work as an independent producer representing multiple insurance companies.
Larry began his career with Massachusetts Mutual Life Insurance, where he was named New Agent of the Year. He has authored a large number of articles and publications and is often quoted by the media on insurance topics. Ziff has received numerous outstanding performance awards and is considered by industry players to be in the top tier of insurance brokers nationwide.
