Bone Marrow Banking for Cell Therapy Material at Scale (Kevin Caldwell, Ossium Health)
Translating Aging
Do You Have to Do Clinical Trials for Cellular Products?
The FDA looks at the extent to which the product you're making has been manipulated. If it is less than minimally manipulated and it's used homologously, then the applicable regulatory framework can be different. For most of our programs, like the programs for treating GVHD, they're going through this pathway.
In today’s episode, Chris sits down with Kevin Caldwell, CEO, Co-Founder, and President of Ossium Health, a company that aims to improve human health and longevity through bioengineering - specifically using stem cell science to create materials for cell therapies. Together, they discuss Ossium’s approach: processing and banking of bone marrow from organ donors, which can then be cryopreserved and used for various clinical applications such as bone marrow transplants for blood cancer patients and emerging stem cell therapies. Kevin also shares details of his background as a lawyer in the stem cell industry and the potential of stem cell therapies in increasing the availability of bone marrow for treatment options.
He then goes on to describe his company's clinical programs and their goal of increasing the percentage of patients who ultimately get bone marrow transplants. In addition, he reviews the company's plans for using stem cell therapies in preventive medicine, their focus on improving long-term health and lowering costs, and the company's clinical trial for treating GVHD. Finally, he says a few words about Ossium’s place in the longevity biotech sector.
Listen in today to not only learn about the potential of stem cell therapies and the importance of increasing the availability of bone marrow for treatment options for blood cancer patients, but to also gain valuable insights into the future of healthcare itself.
The Finer Details of this Episode:
- Ossium Health and the work it does
- Processing and banking bone marrow from organ donors
- Kevin Caldwell’s professional background
- The potential of stem cell therapies and the impact of increasing the availability of bone marrow
- The clinical applications of cryopreserved bone marrow
- The technicalities and the importance of cryopreservation of bone marrow.
- Ossium Health's clinical programs and their focus on treating patients with acute myeloid and acute lymphoid leukemia.
- The company's plans for using stem cell therapies in preventive medicine
- Their focus on improving long-term health and lowering costs.
- The goals of Ossium Health
- Ossium’s clinical trial for treating GVHD
- Working with the FDA
Quotes:
"Every year in the United States, there are about 20,000 people diagnosed with leukemia who go looking for a bone marrow transplant… 40% of those people… ultimately do not receive a transplant. Many of those people die while looking for a donor."
"Other people become so weak during the process of searching for a donor that they're taken off the list."
"There are also many emerging applications of the stem cells that are native to the bone marrow, treatments for diseases of inflammation, treatments that enable people to receive organ transplants without immunosuppression."
"Ossium has developed a process for processing and banking bone marrow from organ donors, cryopreserving those cells, and then doing further selection and engineering on the cells to prepare them for different clinical applications."
“There's a number of steps that we have to take to go from that solid bone to bone marrow for cryopreservation.”
"Our goal is to dramatically increase the percentage of patients who ultimately get bone marrow transplants."
"Bone marrow transplants are not FDA regulated. They're treated like organ transplants by law."
"One of the things about prevention that is most powerful is that if you achieve it, you can both improve long-term health relative to retrospective treatment, and ultimately lower cost. For us, prevention is a North Star.”
“If we think about our goal of trying to broadly improve human health, one system that is involved in our response to essentially all disease is the immune system.”
"At Ossium, what we're really building is the ability to systematically reconstitute, restart, reset, and renew the human immune system."
"For the rest of the recipient's life, they will produce blood and immune cells from the donor's bone marrow."
"One of the things that's exciting about that is that the donor cells will be able to recognize and respond to new disease threats."
“The set of innovations that is going to allow us to extend our healthspan meaningfully from what we have now toward something that gives us another chapter of healthy life is going to look very different from the set that allowed us to go from the lifespans we had a century ago to today.”
Links:
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