Author/Authors :
Larijani Bagher نويسنده , Gilany Kambiz نويسنده Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium , Rahim Fakher نويسنده Toxicology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran , Adibi Hossein نويسنده Endocrine and Metabolism Research Center, Tehran University of Medical Sciences, Tehran, Iran. , Falahzadeh Khadijeh نويسنده Department of Genetics at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran , Goodarzi Parisa نويسنده Brain and Spinal Injury Research Center, Tehran University of Medical Sciences , Arjmand Babak نويسنده Brain and Spinal Injury Research Center, Tehran University of Medical Sciences , Aghayan Hamidreza نويسنده cGMP Grade Stem Cell Facility, Chronic Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute,
Tehran University of Medical Sciences, Tehran, Iran. , Mohamadi-Jahani Fereshteh نويسنده Department of Biology, Payame Noor University, Tehran, Iran. , Payab Moloud نويسنده Obesity and Eating Habits Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, IR Iran , Tayanloo Beik Akram نويسنده Cell Therapy and Regenerative Medicine Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, IR Iran
Abstract :
[Background]Among different kinds of cells involved in the wound healing process, fibroblasts play a pivotal role in the proliferation phase of this procedure wherein they induce the production of local growth factors and cytokines. Fetal fibroblasts with low immunogenic property and different wound healing process could be considered as a suitable alternative to neonatal foreskin cell based products in regenerative medicine and cell therapy. Cell therapy is an almost newly introduced method in the medical field and is also a challenging issue, which should assure the safety of the final product and the absence of viral or bacterial contamination with minimal immunogenic response. Therefore, based on current GMP (cGMP) principles, it is a matter of great importance to monitor raw materials’ quality and the conformity of all production procedures including cell culture, collection, and cryopreservation with validated standard operating procedures (SOPs). In the current study, we demonstrated the GMP-compatible and clinical-grade fetal fibroblast cells banking to be used for clinical applications.[Methods]All steps of isolation and culturing and cryopreservation of fetal fibroblast cells were performed under the sterile condition according to cGMP guidelines in the clean room. During the cell culture procedures, bacteriological investigation was performed in order to identify the probable contamination of the samples.[Results]Isolated fetal dermal fibroblasts were harvested and stored at early passages. The viability of fibroblasts was ≥ 98%, indicating successful establishment of fibroblast banking. Flow cytometry analysis has revealed the high purity of isolated and cultured fibroblastic population Karyotyping of fibroblasts at the 10th subculture shows a normal diploid male pattern.[Conclusions]The manufactured cells, according to the highest level of safety are considered as the most appropriate treatment option for cellular therapy. Based-on the current evidence, clinical-grade fetal fibroblasts throw new light on efficient and prompt healing of acute and chronic wounds of any etiology.
