At Rejenevie™, we spent five years developing a sophisticated animal model to test our immune restoration therapy. Because the mouse genome is close in similarity to the human genome, and because it’s far easier to manipulate and change, there are many components of mouse biology that can easily be adapted to mimic human biological systems. (1)
A humanized mouse is one that has been engineered to eliminate the mouse immune system and is transplanted with human hematopoietic stem cells. Over 15 weeks, the mouse develops a human immune system, which we have used as a preclinical model to test our technology. The main findings observed from our humanized mouse studies were:
No significant safety concerns
After 15 weeks, restored mice exhibited:
Increased blood T cell production and stimulatory activity
Increased blood CD4/CD8 T cell ratio
Decreased blood myeloid/lymphoid ratio
Increased bone marrow hematopoietic stem cell function
The Transwell System
The immune restoration technology at Rejenevie™ is based on the Transwell system. In this two-chamber system, young cells are placed in the top chamber and aged cells are placed in the bottom chamber. The cells interact, but cannot mix, because they are separated by a Transwell filter containing nano-pores of 400 nm in size. These allow young “factors” to penetrate the pores. The factors include exosomes, proteins, microRNAs, lipids and other cellular material that are taken up by the aged cells.
After seven days, we discovered improvements in aged stem cell function and in aged immune function. This is what we desired since no other similar studies to date had shown this dramatic effect on the aging immune system. We believe our science, methods, and technology distinguish our results from the rest of the field.
For more on the Transwell system, view our video:
Over five years of testing, we found our therapy was both safe and effective. These results allowed us to transition our therapy from the lab into the clinic. Our Phase 1 trial started by obtaining regulatory approval to treat patients in the Bahamas. We submitted our application in early 2017 to the Bahamian National Stem Cell Ethics Committee. Within one year, Rejenevie™ received approval to treat our first patient. To reach that point, we created a GMP (Good Manufacturing Practices) laboratory at our clinic, Okyanos Center for Regenerative Medicine, located in Freeport. Our first patient was treated on December 15, 2017, and we completed our Phase 1 trial of five patients in February 2019.
We’re very excited with the results so far. The majority of patients demonstrate an increase in natural killer cell function, a measure of the immune system’s ability to fight and kill cancer cells. Our data also has shown an increase in the ratio of infection- and cancer-fighting lymphoid cells compared to the pro-inflammatory myeloid immune cells. Finally, and most impressively, we’ve seen a dramatic decrease in the number of aging-related genes that are expressed in the circulating immune cells of our patients. Now that our Phase 2 trial has been approved, we are actively recruiting and treating 15 to 20 additional patients at Okyanos. We expect to complete this cohort of our study over the next 12 months.