Overview & Safety
There are 10 steps to Rejenevie’s Immune Restoration Program.
Step 1: Patient visits a local practitioner, or one provided by our affiliated cell collection facilities. The patient is tested for good general health and cleared to receive the stem cell mobilizing agent. At the same visit, the patient will have baseline blood testing performed within the US by one of the world’s leading diagnostic companies to check immune system functioning.
Step 2: The patient visits one of our nationwide collection centers to receive a daily injection of a stem cell mobilizing agent over the course of five days. (This requires five separate visits to the collection center.)
Step 3: On the sixth day, the patient returns to the cell collection facility to undergo the process of leukapheresis. All the cells that have been mobilized from the bone marrow into the peripheral blood over the past five days are collected. The entire process takes about four-to-six hours and yields a highly concentrated mixture of stem and immune cells.
Step 4: The cells are transported to our US-based cGMP facility for processing and 72-hour cryogenic storage. During that time, the cells undergo quality control testing prior to release.
Step 5: Once the cells have passed the quality control testing, they are transported to Indianapolis for long-term storage in our state-of-the-art biorepository.
Step 6: When the patient is ready to schedule treatment at Okyanos Center for Regenerative Medicine, both patient and donor cells are cryogenically transported from Indianapolis to Freeport, Bahamas. In a seven-day clinical manufacturing process, patient cells are restored with young donor factors using the Transwell system. Cells interact but do not mix.
For more on how the Transwell system works, watch our video.
Step 7: After seven days, donor cells are removed from the Transwell, and the patient cells are centrifuged.
Step 8: The restored patient cells are extensively washed to remove any residual donor factors.
Step 9: The patient arrives at Okyanos in Freeport and is infused with the autologous restored immune cells over the course of a one-hour IV infusion. Thirty minutes after the completion of the infusion, the patient is discharged and can return home.
Step 10: The patient undergoes periodic blood testing using a kit developed with one of the world’s leading diagnostic companies. There are three options for the blood collection: 1.) the patient’s own nurse or doctor may draw the blood, 2.) an approved mobile service can perform the collection at the patient’s home, or 3.) the patient can visit one of the US patient service centers of a leading diagnostic company.
Rejenevie™ immune restoration treatment is considered an autologous therapy because of the two-chamber Transwell system. The filter between the chambers is nano-sized, allowing the young and aged cells to interact but not mix. This design enables us to remove the aged cells without any contamination by the young cells.
Parabiosis is a concept that is now over 150 years old. In the clinical population, no observations suggest that restoration through parabiosis causes any harm. There is no evidence of tumorgenesis, oncogenesis, or enhanced tumor growth. In our initial studies with humanized mice, the organs from animals that received control and restored stem cells were harvested and reviewed by an independent pathologist. There were no findings of pathology in these animals. The totality of evidence demonstrates that parabiotic approaches do not result in harm to the recipient.
A number of anti-aging companies have emerged, some of which use young donor plasma as an anti-aging therapeutic. But young plasma transfusions are plasma alone, they’re stem cell free. Because the transfusions are from a young individual, they are not autologous. Thus, they have potential side effects such as lung damage or anaphylactic reactions. The Rejenevie™ approach is clearly different from and superior to this method.