A Phase 2 interventional study of Fibroblast and fibroblast and gel in Nasolabial Folds, Glabellar Crease and Deep Wrinkles of the Forehead, sponsored by Royan Institute. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-21.
Sponsored by Royan Institute · Phase 2, Interventional, and Treatment
Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. However despite all the care taken passage of time will bring about conditions that will automatically lead to skin aging, which may require certain therapeutic, care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of skin fibroblast along with differentiation of stem cells in the skin tissue is the best method for healing.
Autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested from the patient's normal skin. Biopsies from behind a patient's ear are the source of fibroblasts, which are isolated, expanded through cell culture, and used for the correction of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of the forehead, and acne scars. Prior to final packaging, cell viability is assessed to be at least 85%.
Each single use container of autologous cultured fibroblasts has approximately 20 million cells aseptically processed and suspended in 1 mL of sterile, buffered Dulbecco's Modified Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Cell product
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's enrollment of 60 is above the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.
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Exclusion Criteria:
Injection of autologous cultured fibroblast
Biological: Fibroblast · Biological: fibroblast and gel
20 million cell in three injection
Also known as: cell alone
20 million cell in three injection plus filler
2-point shift in at least one treated area using a standardized 7-point photoguide
Time frame: 6 months
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Royan Institute