by Tom Renz, Tom Renz Substack:
As of March 21, 2024, the NIH National Human Genome Research Institute lists the definition of gene therapy as a ‘technique that uses a gene(s) to treat, prevent or cure a disease or medical disorder’. The FDA has a similar definition and currently lists gene therapy as a ‘technique that modifies a person’s genes to treat or cure disease’. According to the FDA’s website there are a variety of types of gene therapy products, two of which are listed below:
- Plasmid DNA: Circular DNA molecules can be genetically engineered to carry therapeutic genes into human cells.
- Viral vectors: Viruses have a natural ability to deliver genetic material into cells, and therefore some gene therapy products are derived from viruses. Once viruses have been modified to remove their ability to cause infectious disease, these modified viruses can be used as vectors (vehicles) to carry therapeutic genes into human cells.
TRUTH LIVES on at https://sgtreport.tv/
Interestingly, mRNA and other RNA tech is left out of this list. The reason this is so curious is that “transcribed RNA” is listed as gene therapy in a 2020 FDA document titled Human “Gene Therapy for Rare Diseases”. Transcription is the process by which DNA creates RNA. The “transcribed RNA” is quite literally mRNA (here’s a very simple link explaining: https://www.genome.gov/genetics-glossary/Transcription) Specifically the document (found here: https://www.fda.gov/media/113807/download) states:
If that’s not enough, the U.S. Department of Health and Human Services, the FDA and the Center for Biologics Evaluation and Research published a 2015 guidance for industry document: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products which defines gene therapies as “products that mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome and that are administered as nucleic acids, viruses or genetically engineered microorganisms. The products may be used to modify cells in vivo or transferred to cells ex vivo prior to administration to the recipient.”
“For purposes of this guidance, a vectored vaccine is one that uses a virus or microbe (typically a bacterium), or a DNA plasmid to introduce DNA/RNA encoding for antigens to cells of the body. “Vector” refers to the virus microbe or DNA plasmid used as the carrier.”
This is critical. When we talk about viral vectors they are simply the vehicle by which the DNA/RNA payload is delivered to the cell. Viral and bacterial vectors have the exact same role that lipid nanoparticles have. They carry the payload. It is the payload that makes a product a gene therapy product – not the delivery vehicle.
Read More @ tomrenz.substack.com
