Ann: Change of Director's Interest Notice - Silviu Itescu, page-128

No, not for regulatory approval, but the compassionate use program does prove the Physicians using it believe it does work and the FDA do not consider it blatantly unsafe, nor there any decent alternative for its patients to use, per compassionate use FDA guidelines:

Patient has a serious or immediately life-threatening disease or condition.
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
Patient enrollment in a clinical trial is not possible.
Potential patient benefit justifies the potential risks of treatment.
Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.