Ongoing Study at University of Louisville: IV Stem Cells for Heart Failure
In short:
Testing the use of umbilical cord-derived stem cells in patients for heart failure
They mention it’s the first to use intravenous (IV) delivery of cell therapy for the condition
There are many conditions with almost no answer from the medical system.
This includes things like neuropathies, Schizophrenia, TBI, Lupus, Cystic Fibrosis, pain, Multiple Sclerosis, spine damage (yay), and the list goes on. Life is a health gamble, and you hope it’s not you, but if it is… good luck. Going through it as I type this myself, and know many others in the same spot.
However, there’s the new kid on the block, stem cell therapy, which remains relatively unproven, yet has un-ignorable anecdotes and claims. Fortunately, US universities are working on it, and enrolling clinical trials to finally prove/disprove it, this is one of many examples.
What are they doing?
At U of L, researchers will take 100 million umbilical cord-derived stem cells, and administer them by way of IV to see if it heals post heart attack damage. The study will be double-blinded, and placebo-controlled, with plans to recruit 60 patients. It appears they’ll receive 4 treatments consisting of 3 placebos, and 1 cell treatment. They’ll follow with objective data like heart scarring/size via MRIs from John Hopkins, along with subjective data like exercise tolerance and life quality.
Patients must be surgical candidates, and hopefully, we’ll get some good data comparing the long-term outcomes of stem cells versus traditional surgery.
Two very interesting question marks on this study:
1 - There are many claims that freezing (cryopreserving) stem cells kills them, rendering them useless, citing a study self-funded by Regenexx, along with other studies.
However, there are studies about cryopreservants (chemicals added to protect the cells from freezer burn) and best practices, showing post-thaw viability. If you talk to companies who don’t offer Wharton’s Jelly, they’ll cite the former, if you talk to a Wharton’s Jelly clinic, they’ll cite the latter. It’s quite confusing.
The study says “The cells will be manufactured at the Interdisciplinary Stem Cell Institute at the University of Miami, Miller School of Medicine and then shipped to the Site for administration.” Note that this appears to be the Miami, Florida university (University of Miami), not Oxford, Ohio (Miami University).
Studies show that after thawing, stem cells can begin to die (apoptosis) within a few hours. Given the distance from Florida to Kentucky, about a 10-hour drive, I think it’s safe to assume they’ll cryopreserve the cells and ship to Kentucky, and obviously the researchers believe that they’ll be viable following this, especially seeing as they received an $8M grant.
The article also says “The cells can be manufactured and stored frozen, readily available for patients when they need them. This is a significant advantage over other cell therapies, for which cells must be manufactured from the patient’s own tissues, which increases cost and lead time for the treatment.”
2 - IV administration has also been cited as ineffective, due to pulmonary pass.
If you don't know what pulmonary pass is, in short, the lungs (pulmonary system) act as one of the many filters in the body, and it's been studied that stem cells are too large in size to get through this:
In this study, they gave IV stem cells to rats, and found the cells didn't get past the lungs. Meaning (assuming that's true) IV stem cell administration doesn't actually reach all the tissues that clinics claim it does. However, in my opinion, that needs further clarification.
Quoted from that study:
"All groups except group B cells were intravenously administered in one bolus (2 × 10^6 cells). In group B we injected MSCs (4 × 10^6 cells total) via two equal boluses (2 × 10^6 cells each)."
Why's that interesting? Well, in medicine, dosage matters. A lot actually. In the study, rats were given 2 - 4 million cells. If you think about rats, they weigh about a pound give or take. Now, let's say for numbers sake the average human weighs about 180 pounds. So, the dosage appears to be about 3-7x what you'd give a human. Doesn't mean it's debunked, but that's an interesting detail to note, and I'd assume U of L and University of Miami know all about this study. I wonder what their take is on that.
Additionally, I've read on stem cell clinic blogs that the way they measured to see if the cells reached other tissues is disputed, but haven't dug in enough to know myself.
Regardless, I'm looking forward to hearing more about this.
Study details - https://clinicaltrials.gov/study/NCT06145035
