Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging
|Chronic Effect of Ultraviolet Radiation on Photoaged Skin Dermatologic Disorders||Biological: Allogeneic Mesenchymal Bone Marrow Cells||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- MSC Safety and Tolerability [ Time Frame: 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)
- MSC Efficacy [ Time Frame: 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)
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Experimental: Allogeneic Mesenchymal Bone Marrow Cells
1550 nm Fraxel laser treatment (6-8 mJ, Level 2) to full face followed by IV infusion of Allogeneic Mesenchymal Bone Marrow Cells (0.5, 1.0, or 1.5 million cells/kg, up to 150 million cells)
Biological: Allogeneic 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771679
|United States, California|
|La Mesa, California, United States, 91942|
|Naval Medical Center San Diego|
|San Diego, California, United States, 92134|