RE:RE:RE: Theralase vs Moderna Vestor,
I don't know how it goes in Canada, but in the USA under FDA rules, the patient's own cells can be operated on to separate them or concentrate them, and they can then be reinjected as the patient's own, but that has to happen the same day. If the extracted cells are cultured in vitro to increase their numbers, then the cultured cells are treated as a drug requiring a full and complete Phase 3 clinical trial to prove safety, tolerability, and efficacy.
The stem cell industry has been fighting this classification for at least ten years to no avail. Stem cells extracted from an individual can be separated, concentrated, counted and evaluated, and then reinjected into the patient the same day. If the stem cells are cultured to increase their numbers, then the stem cells are classified as a drug and subject to the Phase 3 clinical testing requirements.
To date, no stem cell provider has spent the serious money to run a Phase 3 clinical trial. For this reason, there are no legal off the shelf stem cell treatments available in the USA. One has to travel offshore where the FDA does not have authority in order to obtain treatment with cultured stem cells, or simply to have one's own stem cells cultured over time to increase their numbers and thereby increase the projected benefit of a stem cell procedure.
Note there is one very limited exception to this in the case of certain pediatric patients.