Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging (NCT01771679) | Clinical Trial Compass
UnknownPhase 1/2
Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging
United States29 participantsStarted 2015-07-01
Plain-language 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.
Who can participate
Age range40 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wit…