3. The patient has an unstable medical condition according to the investigator, including, but are not limited to, an aggressive disease requiring systemic chemotherapy, uncontrolled diabetes mellitus Hgb A1c : >/= 8.or hypertension ( BP >/=140/90) or in the doctors opinion, active infections requiring systemic antibiotics, antivirals, or antifungals, unstable congestive heart failure, uncontrolled arrhythmias, unstable angina pectoris, unstable coagulation disorders, or psychiatric illness/social situations that would limit compliance with study requirements.