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

STEM 102-M

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.

2015-07-01

2024-04-30

2024-12-31

Active (not recruiting)

Early phase I

29

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 29, 'type': 'ESTIMATED'}}

2022-10-31