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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Effect of Ultraviolet Radiation on Photoaged Skin
- Sponsor
- Stemedica Cell Technologies, Inc.
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- MSC Safety and Tolerability
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- MSC Efficacy(12 months)