I’m Pedro Silva Couto, and this blog combines content from my personal blog, Cell and Gene Therapy Today, together with data from my membership on the team at CellTrials.org.
Recent clinical trials of note within the cell and gene therapy space
News
I’m Pedro Silva Couto, and this blog combines content from my personal blog, Cell and Gene Therapy Today, together with data from my membership on the team at CellTrials.org.
Based on CellTrials.org data, we forecast that there will be more than 200 additional allogeneic CAR-immunotherapy trials over the four years 2022 through 2025.
During in vivo gene therapy, the gene modification takes place inside the patient’s body, rather than modifying cells outside the body and then giving the cells to the patient. Our in vivo gene therapy database is a searchable and sortable list of 15 parameters for 879 trials from 2011 to 2021. The trials were collected with uniform search criteria, throughout a uniform time period, consistent with academic standards. A total of 66,867 clinical trials were searched worldwide to find the 879 trials of in vivo gene therapy.
CellTrials.org has released our 2021 package of worldwide clinical trials in advanced cell therapy. The pandemic bump in numbers of cell therapy trials is over.
We tabulate several parameters for all Expanded Access programs giving advanced cell therapies that were FDA-approved from 2017 through mid-2021. The regulations governing cost recovery of Expanded Access programs are also described.
Virus-Specific T-cells (VST) from recovered donors can be banked and grown in the lab to help patients fight COVID-19.
Images: Cells at Work! is a Japanese manga series written and illustrated by Akane Shimizu. It features the anthropomorphized cells of a human body, focusing on the interactions of blood and immune system cells.
Between 2019 and 2020, the number of new clinical trials in advanced cell therapy increased by 29%. All categories of trials increased, but the most dramatic rise was a near doubling of trials that employ MSC. COVID-19 trials accounted for about 80% of the increased number of MSC clinical trials.
As of August 2020, there are 230 companies worldwide developing CAR-immunotherapy, and 80 (35%) of those companies have allogeneic products in their pipeline. These allogeneic CAR products are spread across 15 nations, with 48% in the United States and 83% outside of China.
A simple search for keywords leaves the impression that there are hundreds of exosome clinical trials. But once we apply the requirements that the product meets the ISEV definition and has a clearly defined purification step, there are less than one hundred exosome clinical trials worldwide to date.