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

Mesenchymal stem cells (MSCs) have been isolated from a number of sources, including bone
marrow, adipose tissue, and peripheral blood. The MSCs manufactured for this study are a
subset of non-hematopoietic stem cells derived from the bone marrow of healthy, adult
donors. These cells have the ability to migrate to areas of injury in the body and can
differentiate into multiple cell types, including cutaneous cells. In addition to
contributing directly to repair of the skin by replacing damaged cells, MSCs also stimulate
the body's own cells to regenerate.

Though an increasing number of patients are seeking remedies for photoaged skin, current
treatments, ranging from topical medications to laser peels, are not ideal methods for
addressing the medical need. Because MSCs have been shown in clinical and non-clinical
applications to be useful in wound healing, it is also possible that the cells will have a
similar effect in skin rejuvenation.

In the present study, we will determine the efficacy and safety of intravenously delivered
MSCs in otherwise healthy patients with significant cutaneous photodamage.

Key Inclusion Criteria:

- Males and Females 40-70 years of age

- Good general health

- Fitzpatrick skin type I-III

- Fitzpatrick Wrinkle Scale class III. Fine to deep wrinkles, numerous lines with or
without redundant skin folds

- Ability to understand and provide signed informed consent

- Reasonable expectation that subject will attend all scheduled safety follow-up visits

- Reasonable expectation that subject will maintain skin care regimen for the duration
of the trial

- Adequate organ function

Key Exclusion Criteria:

- History of neoplasm, including basal cell carcinoma, within the past 5 years

- 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

- Cosmetic surgical treatment in past 6 months before Study Day 1 (includes laser,
chemical peels, fillers, botulinum toxin, and other cutaneous surgery)

- 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)

- Presence of any other clinically significant medical condition, or laboratory
abnormality that in the judgment of the Investigator or Sponsor 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 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 must use an effective method of birth control, such
as complete abstinence, surgical sterilization, hormonal contraceptive, diaphragm or
condom with spermicide, or an intrauterine device, for the entire period of the
clinical trial (approximately 13 months from the screening visit)

- Allergies to bovine and porcine products