The Cell and Gene Therapy Clinical Manufacturing Program in the IU School of Medicine was established a couple of years ago to work on cell and gene immunotherapy process development and manufacturing, and when the coronavirus pandemic began, Dr. Sreedhar Thirumala, director of the program’s process development and manufacturing, knew that the work being done in the lab would be important.
The lab works with stem cells and other cells to build a process that will allow them to develop products that can be used to treat patients. “We take the idea from the investigator, and help to develop the drug product,” Dr. Thirumala said. This work can encompass preclinical studies, human trials, FDA approval, working in a clean room, a focus on patient safety and documentation.
Stem cells can help a body to produce an anti-inflammatory response, thus helping patients to heal faster. Prior to the pandemic, these cells were used for a variety of issues, including knee problems. Stem cells are typically administered through an IV, and they travel first to the lungs. Most stay there, but some travel on to the site of inflammation helping the body to heal. According to Dr. Thirumala, this was a drawback of stem cell therapy using IV administration, but in coronavirus patients, this is benefit, because of the virus’ effect on the lungs. Similar research into stem cells effect on coronavirus patients is being done in several locations around the world.
Dr. Thirumala and the program hosted an LHSI intern in 2019, and they have plans to host two more in 2020. Interns will work on research to identify better protocols and methods for product development, and they will be involved in the COVID research in the lab.
“This is a great opportunity for students to learn and understand how research works. It’s not the same every day. You have a change and adapt, and always be thinking how you can make the process better. These are things that the students learn in the lab,” Dr. Thirumala said. “The students are young, dynamic, fresh-minded, and eager to learn things. It is important that they can get exposed to the latest developments in the field. We have had great success with these students.”