When a company decides to sponsor an FDA clinical trial, there are several stages before a specific indication is approved. Once the FDA approves the implementation of the human aspect of drug studies or drug trials, there are specific methods those studies use to make them valid.
You can search FDA approvals lists via various online sources.
To demonstrate that these treatments are working and get FDA approval, companies need to conduct studies of other treatments. This could be the current gold standard for treating the condition, or it could be called a placebo.
In the case of a stem cell injection clinical study, the regenerative drug injection test was compared with a placebo. The placebo can be a saline solution or a drug-free liquid. This shouldn't have any real impact on the patient but is known to have about 30% of the time.
Finally, if a patient meets the inclusion criteria for the FDA clinical trial, they will be randomized to one of the groups. Sometimes this comes from envelopes or computer-generated sequences that ultimately show what care the patient received.
The usual method is when 100 patients are selected for a clinical trial, 50 are in the treatment arm and the remaining 50 are in the randomized placebo arm to ensure there is no selection bias.
In clinical stem cell studies, the patient is then monitored periodically, with objective and subjective information examined. This means learning how much pain reliever the patient needs after the injection and checking the results on a pain scale while the test is taking place. All side effects from the injection were noted and if a very serious situation existed, the FDA was notified immediately.