Chronic Effect of Ultraviolet Radiation on Photoaged Skin, Dermatologic Disorders
Conditions
Keywords
Mesenchymal Stem Cells, Bone Marrow Cells, Allogeneic Transplantation, Skin Wrinkling, Solar Aging of Skin, Intravenous Administration
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAllogeneic Mesenchymal Bone Marrow Cells
Subjects in Part 1, Cohorts 1-3 will receive a 1550 nm Fraxel laser (6-8 mJ, Level 2) treatment on the face followed by a single intravenous infusion of 0.5, 1.0, or 1.5 million mesenchymal cells per kg of body weight, not to exceed 150 million cells. Subjects in Part 2 will receive a 1550 Fraxel laser (6-8 mJ, Level 2) treatment on the face followed by a single intravenous infusion of mesenchymal cells at the Maximum Tolerated Dose, as determined by the safety results of Part 1. The dose in Part 2 is 1.5 million cells per kg, not to exceed a total of 150 million cells.
Sponsors
Stemedica Cell Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MSC Safety and Tolerability | 1 year | The primary endpoint will be the safety and tolerability of IV administration of allogeneic mesenchymal bone marrow cells (aMBMC) during the twelve month study period as determined by the incidence and severity of adverse events, clinically significant changes on clinical laboratory tests, vital signs, physical and cutaneous examinations, 12 lead ECGs and CT scans of the chest (without contrast) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MSC Efficacy | 12 months | * VISIA-CR 2D photography * PRIMOS 3D images of face and neck * VECTRA 3D photography * Punch biopsy from the lateral canthal area to examine changes in decorin, fibrillin, elastin, MMPI, and procollagen-1 * Subject self-assessment * Independent evaluator assessment * Principal investigator assessment * Changes in RNA sequencing (from blood specimens) * Changes in MMP-1, Ang-2, VEGF and FGF (from blood specimens) |
Countries
United States
Outcome results
None listed