Interesting development.The Leiden University Medical Center...

Interesting development.

The Leiden University Medical Center (LUMC) previously sponsored a 10 participant Phase 1 clinical trial, entitled "Allogeneic Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients (Neptune)":


https://clinicaltrials.gov/ct2/show/NCT02387151

Now we may see that trial design re-applied to a trial using "iPSC-derived Mesenchymal Stromal Cells" instead of bone marrow derived MSCs.

An interview with Prof Ton Rabelink mentioned the following back in 2018:

Last year, you finished work on a project called STELLAR to look at how regenerative medicine can help people suffering from chronic kidney disease. What did you do?

‘Progressive chronic kidney disease is not only a clinical problem, but an economical one. Apart from intensive care and treatment, chronic kidney disease is our most expensive illness. Every dialysis patient costs about €80,000 per year and that’s still a very poor treatment.

‘We wanted to increase the availability of organs for transplantation and to explore whether we could reduce chronic kidney disease. There is a small population of what are called mesenchymal stromal cells (MSCs) in the bone marrow. In 2006, scientists at the Karolinska Institute (in Sweden) discovered that if you take a biopsy from the bone marrow, expand the cells and then reinfuse them, they have an immune suppressant and regulatory effect, and create a pro-regenerative environment. Experiments in animals showed they could retard the progression of kidney disease but the real trick is, can you bring this to a human population? Our group was among the first to do clinical trials using these cells in our hospitals.

‘Then … we did some experiments with discarded kidneys, which had been offered for transplantation but couldn't be used for technical reasons. We found that similar cells were present in the kidney itself, which would have additional benefits over those from the bone marrow — a next generation type of cell. We’re starting a phase one study (to test doses and side effects in humans) with these kidney stromal cells. This will focus on revitalising and preserving organs for transplantation that otherwise would have ended up the garbage bin, thus increasing the number of donated organs available.

‘Finally, as part of Stellar, we had teamed up with the group of scientists in Australia, one of whom, Melissa Little, discovered that you can actually reprogramme cells and differentiate them into kidney tissue — something people hadn’t realised was possible. The kidney is a very complicated organ with more than 15 different specialised cell types. But if you create the right growth factors, thereby mimicking the early steps in embryogenesis (embryo formation), it’s like loading a software program on your computer, pressing the enter button and then have it start to run. Conceptually, this means that you can take a cell from a patient, reprogramme it into a pluripotent stem cell and then grow your own kidney tissue. It’s still a long way from clinical application, of course, but it’s the most imaginative piece of progress we’ve made.’

https://ec.europa.eu/research-and-innovation/en/horizon-magazine/europe-danger-being-out-innovated-regenerative-medicine-prof-ton-rabelink

It seems like instead of using PSC-Derived Kidney Organoids, they decided to use our MSC software program on their computer, pressing the enter button and then have it start to run.


Btw, the trial is to be funded by LUMC, Cynata will supply the cells and has full commercial rights.