Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging

Exclusion Criteria

• •History of malignant neoplasm within the past 5 years, or Stage 3 or 4 of any cancer at any time
• •History of melanoma, leukemia, or lymphoma (any stage)
• •Persistent pre-cancerous lesions (e.g., actinic keratosis)
• •Active cutaneous infection of the head and/or neck
• •Active cutaneous neoplasm in the treatment area
• •Topical use of any anti-aging creams on the head and/or neck; if used, subject must agree to discontinue for the one year of follow-up on study
• •Cosmetic or surgical treatment on face/neck in 6 months before study (includes laser, chemical peels, fillers, botulinum toxin)
• •Prior treatment with stem cells
• •Positive for hepatitis B, C or HIV
• •Abnormal and clinically significant findings on screening ECG
• •Abnormal and clinically significant findings on screening CT scan of the chest (without contrast)
• •Clinically significant medical condition for which participation in the study would pose a safety risk to the subject
• •Major surgery within 4 weeks of Study Day 1
• •Participation in another study with an investigational drug or device within 3 months prior to stem cell administration
• •Participation in another study concurrent with the one-year duration of the trial
• •History within the past year of drug or alcohol abuse
• •Females known to be pregnant, lactating or having a positive pregnancy test (will be tested during screening) or planning to become pregnant during the study
• •Sexually active males and females of child-bearing potential must use an effective method of birth control for duration of the study (approximately 13 months from the screening visit)
• •Allergies to bovine and porcine products