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The good curative effect of gene therapy products has been artificially led by industry insiders to lead the third industrial revolution of biomedicine
.
On June 4, 2021, the official website of the Center for Drug Evaluation of the National Medical Products Administration issued the "Technical Guidelines for Long-term Follow-up Clinical Research of Gene Therapy Products (Draft for Comment)", and the deadline is July 4, 2021
1.
Why are there special guidelines for long-term follow-up of gene therapy products?
Why are there special guidelines for long-term follow-up of gene therapy products?
Gene therapy: refers to a therapeutic method that modifies or manipulates the expression of genes or changes the biological characteristics of living cells to achieve the purpose of treatment.
The main mechanism of action is the replacement of disease-causing genes with normal genes, inactivation of genes that cannot work normally, or introduction of new ones.
Or modified genes
.
These changes in the biological properties of living cells exist for a long time in the body and may increase unpredictable risks
The main purpose of the long-term follow-up of gene therapy products is to collect the delayed adverse reactions of subjects and understand the existence of gene therapy products in the body, so as to identify and reduce the long-term risk of patients receiving gene therapy products
.
In addition, taking into account the characteristics of the long-term effects of gene therapy products, observing the changes in the efficacy over time is also an important purpose of long-term follow-up
2.
Long-term follow-up observation time for gene therapy products
Long-term follow-up observation time for gene therapy products
The duration of the long-term follow-up should be sufficient to observe the risks of the subject due to product characteristics, exposure (biodistribution and route of administration), etc.
, and should not be shorter than the expected occurrence of delayed adverse reactions
.
The follow-up time of a specific product depends on the characteristics of the product and the existence time in the body, the time of transgene expression, the expected time and incidence of late adverse reactions, the indications and expected survival period of the subject, the route of administration, and other long-term follow-up Observe the purpose
3.
Long-term follow-up risk assessment strategies for gene therapy products
Long-term follow-up risk assessment strategies for gene therapy products
At present, the development of gene therapy products is gaining momentum.
According to reports, there are more than 2,000 gene therapy clinical trials in progress worldwide
.
However, it can also have long-term or permanent effects on the human body.
references
[1] http://
