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

A Phase I/II, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects for Cutaneous Photoaging

The purpose of this study is to determine whether a one-time injection of allogeneic mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the face.

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 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