Can This Company's Research Help Transform Regenerative Medicine As Its Lead Product Receives FDA IND Approval?

Learn More about Organicell Regenerative Medicine, Inc. by gaining access to the latest research report

In the medical community, the popularity of regenerative medicine is reportedly soaring primarily because research around these therapies shows promise in treating a wide range of musculoskeletal pain conditions.

Armed with the belief that the human body can heal itself, regenerative medicine treatments like exosome therapy and stem cell therapy are advancing.

But regenerative medicine has sometimes been embroiled in controversy beginning in 1981 when scientists discovered ways to derive embryonic stem cells from early mouse embryos.

That discovery was followed by a method to derive stem cells from human embryos and grow the cells in the laboratory in 1998.

Massive players like Amgen Inc. AMGN, Sanofi SA SNY, and Gilead Sciences Inc. GILD have advanced stem cell research and therapies.

Is Exosome Therapy Different?

Unlike stem cell therapy, Organicell’s OCEL exosome therapy doesn't involve using donor cells or umbilical cords. Instead, the exosomes are extracted from full term, planned C Section, Amniotic fluid. The extracted exosome solution is derived from amniotic fluid and contains over 300 soluble proteins as growth factors, cytokines and chemokines, extracellular matrix proteins as fibronectin and collagen, structural molecules as hyaluronic acid, Nanoparticles as extracellular vesicles, exosomes and surfactants proteins, valuable lipids, micro-RNA, messenger-RNA, and cytokines.

Exosome therapy, according to experts, is a highly targeted, flexible treatment believed to help inflammatory conditions like COPD, Long Covid, musculoskeletal injuries, osteoarthritis, and chronic pain.

What’s the difference between Exosomes and Stem Cells?

Try to think of Stem Cells as microchips in a computer. Exosomes are like the software. 

South Florida-based Organicell Regenerative Medicine Inc. OCEL is a company that is a pioneer in the exosome space. Their products are designed to operate  like software for the computers of our body known as cells. However, the software Organicell uses is naturally occurring and unaltered. Organicell extracts its exosomes from what is believed to be one of the most naturally healing fluids on the planet, amniotic fluid. The software/exosomes in this fluid reminds the body what it used to do when it was young. 

To put things plainly, the “software” (exosomes) is a set of instructions, data or programs used to operate the “computers” (cells) and execute specific tasks, while a computer-chip (stem cells) are used more as building blocks in  regenerative medicine.

Potential Benefits

The potential benefits of Organicell’s products could be enormous. For example, the company's investigational product Zofin™ is an acellular, non-HCT/P biologic, currently being studied in clinical trials. The company accomplished the difficult task of an approved investigational new drug (IND) from the U.S. Food and Drug Administration (FDA) which lead to approved clinical trials..

Zofin™ is derived from perinatal sources and is manufactured to retain the naturally occurring nanoparticles and microRNAs without manipulation or adding or combining any other substance.

Zofin™ is currently being studied in FDA Phase I/II clinical trials for COVID-19, Long Covid, Chronic Obstructive Pulmonary Disease (COPD), and ready to begin a trial for Osteoarthritis of the knee.

Below are the results that were published on the COVID patients treated with Zofin under eIND approval.  The important items in the chart are the key biomarkers that measure inflammation: IL-6 and CRP as well as the chest X Rays that show the structural difference in the lungs over time.   

A Better Approach?

Organicell reports that its mission is to be the first company to prove the efficacy of extracellular vesicles (EV's) — a.k.a exosomes — on inflammatory ailments. Organicell has two active FDA approved clinical trials for Long Covid and COPD.

The company says through its ground-breaking research in the field of nanotechnology, specifically perinatal-derived EVs, it has created the drug candidate, Zofin, that could be the next frontier of regenerative biologic therapeutics.

Organicell’s proprietary product’s biological representation is allogenic amniotic fluid (secreted body fluid, non-HCT/Ps), which is an acellular product derived from human amniotic fluid (HAF). The product contains no addition or combination of any other substance or diluent during production.

Moreover, the product quality assurance is seemingly unmatched in the regenerative medicine space. the donor from whom this product was derived has been tested and found negative for the following: HBsAg (Hepatitis B Surface Antigen), HBcAb (hepatitis B core antibody), HCV (hepatitis C antibody), HIV I/II-Ab (Antibody to Human Immunodeficiency Virus Types 1 and 2), Syphilis detection test, HIV NAT (HIV Nucleic Acid Test), and HCV NAT (HCV Nucleic Acid Test). 

Additional donor screening tests may have been performed on the donor. If additional tests for Human Immunodeficiency Virus, Hepatitis B, Hepatitis C or Syphilis were performed, the results were reviewed and found to be NEGATIVE. 

Additional tests for other communicable diseases, such as West Nile Virus, T. Cruzi, Cytomegalovirus and Epstein Barr Virus may have been performed. The results of all additional communicable disease tests have been evaluated by the Medical Director and have been found acceptable according to regulations, standards and Standard Operating Procedures (SOPs).

Donor screening tests are performed by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and American Association of Blood Banks (AABB) using FDA licensed tests when available performed by VRL Laboratories.

The donor is selected based on medical and social history which meets the Standards of the American Association of Tissue Banks (AATB) United States Public Health Service (USPHS), and the Federal Food and Drug Administration (FDA). 

Donor suitability was determined by the Manufacturing Facilities’ Medical Directors (Organicell Regenerative Medicine, 1951 NW 7th Ave, Suite 300, Miami, FL 33136). Organicell Factor X is manufactured for clinical use under cGMP-compliant manufacturing facility, to control potency and purity of the product.

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