Right to Try in Action: Notes from the IFATS Symposium
Welcome back! In our last blog, “Stem Cells and Joint Surgery: Why Treating the Whole Joint Matters,” we discussed why successful joint treatment requires looking beyond surgery alone and addressing the health of the entire joint environment to support healing function, and long-term outcomes.
Today I want to take you somewhere a little different: a conference room in Pittsburgh, where I had the honor of speaking last Sunday.
On October 11, I presented at the International Federation for Adipose Therapeutics and Science (IFATS) Special Symposium on Regeneration and Longevity, held at The University Club in Pittsburgh. IFATS brings together physicians and scientists who work with fat-derived (adipose) stem cells. My talk was titled "Advancing Clinical Therapies with Adipose Stem Cells: 'Right-to-Try' in Action." Here is the heart of what I shared, in plain language, plus a few highlights from the other speakers.
So, What Is "Right toTry"?
Right to Try is a federal law passed in 2018. It gives patients with serious conditions, working together with their own physician, a path to therapies that are still moving through the full approval process. Your own stem cells from PSC qualify, because our product has completed an early-stage (phase 1) safety study and is made in our pharmaceutical-grade lab in San Diego.
In general, a patient may be a candidate if:
• They have alife-threatening or seriously debilitating condition
• They havetried, or considered, the approved treatment options
• They are notable to join a clinical trial of the product
The key point I made to the room: this decision is made by you and your doctor. I also asked physicians to think hard about what "seriously debilitating" really means. Advanced arthritis is a good example. It is not "just" joint pain. In my talk I noted that osteoarthritis is associated with a 50% increase in all-cause death compared to people without serious osteoarthritis. Chronic hand or back pain and stubborn nerve pain can be just as life-limiting.
Hope With Guardrails
Right to Try is not a free-for-all. To qualify, the cells must be made in a pharmaceutical-grade (GMP) lab, the product must have completed a safety study, and the company must be on the formal drug development path. Clinics that skip those steps do not qualify.
This matters, because desperate patients are sometimes drawn to offshore clinics with no such standards. In my talk I pointed to public warnings about those clinics
Where the Science Started: OurAnimal Patients
Many of you know my background is in veterinary medicine. Since 2002, my veterinary company, VetStem, has provided stem cell treatments for about 25,000 animals across 64 species, using the same cell type and the same manufacturing methods we now use for people. Horses, dogs, even the occasional exotic patient helped pave the road to human medicine.
In our human clinical trial of 29 patients with moderately severe knee arthritis, 73.6% had a clinically meaningful improvement at 3 months, and the benefits lasted more than 2.5 years.
From Your Fat to Your Doctor'sOffice
I also walked the audience through the journey your cells take:
• A small fat sample is collected in your physician's office and shipped to our San Diego lab
• Our team grows those cells from about 1 million to more than 100 million stem cells
• Every vial is tested for sterility, identity, cell count and viability
• Your cells are frozen and banked, then shipped back to your doctor when you are ready
• The treatment is given right in your physician's office
Each vial is filled with 18.5 million cells, so you and your doctor know exactly what you are getting.
What's Next: Brain Injury
The part of the talk that drew the most interest was our newest clinical trial, in traumatic brain injury. Enrollment has started in a 10-patient study, beginning with retired Navy SEALs, and we expect to complete it in Spring 2027.
Remember our "paramedic" from an earlier post? After a brain injury, the brain's immune cells can stay inflamed for years, causing ongoing damage. In laboratory studies, stem cells given by IV release signals that help calm those overactive cells and support repair. Like a paramedic with a bag of biomedicines, now headed for the brain. If this trial goes well, it could open the door to Right to Try for many more people living with the effects of brain injury and concussion.
Highlights From the Room
One of the best parts of a meeting like this is learning from colleagues. Two themes stood out for me.
Living well, for a long time.
Dr. Joe Maroon, a neurosurgeon and consultant to the Pittsburgh Steelers, spoke about the lifestyle choices that lead to along and meaningful life: exercise, diet, and social connection. Many of these are things we encourage at PSC every day. Osteoarthritis impairs movement and activity. And he practices what he preaches. Dr. Maroon is in his 80s and just finished his seventh Ironman. Wow.
A word of caution on exosomes.
Several talks covered exosomes, the tiny packets of signals that cells release. The message from the room was clear: exosomes are still very early, they are not approved for patient treatment, and unlike living stem cells, they cannot adapt to what your body needs. A living stem cell senses an injury and adjusts the medicines it produces; a vial of exosomes cannot. The strongest voice for caution was Dr. Peter Rubin, Chairman of Plastic Surgery at the University of Pittsburgh. This lines up with what we shared in our earlier blog on exosomes.
What This Means for You
Right to Try is about putting choice back where it belongs: with you and your doctor, backed by safety guardrails. You can contact our team today to discuss your options.
Stay tuned for our next post, where we'll explore the significance of our FDA-approved clinical trial for traumatic brain injury (TBI) and what this milestone could mean for the future of regenerative medicine.
Common Questions
Once banked through our StemReady™ program, your stem cells are cryopreserved and securely stored, ready for use when you and your physician decide. While not all therapies are commercially available yet, you may qualify for programs like the FDA's compassionate use or the Federal Right-to-Try Act if you have a life-threatening or debilitating condition.
Ask our team how you may qualify.
The cost of our services at Personalized Stem Cells varies depending on the specific treatment plan and stem cell banking options you choose.
Here are the general starting points for PSC services:
- StemPreserve: $2,500, plus banking at $750 per year (first year included).
- StemReady: Starting at $18,750 for 5 vials, which includes preparation of cells for immediate use.
These are your initial costs and do not include any additional fees that your doctor may charge to perform the lipoaspiration or treatment. For a detailed breakdown and to discuss payment options, please contact our customer service team. We're committed to providing transparent and comprehensive pricing information.
Getting started with stem cell banking at PSC is easy. Simply schedule a consultation through our website or contact our team directly. We’ll guide you through the entire process, from the initial collection of your cells to their long-term storage, ensuring you have all the information you need to make an informed decision. Schedule a consultation here.
PSC’s cell therapies are currently being investigated through formal FDA clinical trials with leading scientists and institutions. PSC has completed its first safety and efficacy study and submitted the findings to the FDA. Until formal FDA approval is obtained, PSC cannot make specific claims about this therapy. However, our initial safety and efficacy study is available upon request and has been published in a peer-reviewed journal.
PSC adheres to stringent FDA guidelines to guarantee the safety and quality of your stored stem cells. Our state-of-the-art lab utilizes advanced processing techniques to ensure that your cells are preserved at the highest standards. Every batch of stem cells is tested for sterility and purity.
