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Title

GMP-Compliant Human Fetal Skin Fibroblasts forWound Healing

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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.

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    APA: Copy

    GOODARZI, PARISA, FALAHZADEH, KHADIJEH, AGHAYAN, HAMIDREZA, MOHAMADI JAHANI, FERESHTEH, PAYAB, MOLOUD, RAHIM, FAKHER, LARIJANI, BAGHER, Tayanloo Beik, Akram, Adibi, Hossein, & ARJMAND, BABAK. (2018). GMP-Compliant Human Fetal Skin Fibroblasts forWound Healing. ARCHIVES OF NEUROSCIENCE, 5(3), 0-0. SID. https://sid.ir/paper/354693/en

    Vancouver: Copy

    GOODARZI PARISA, FALAHZADEH KHADIJEH, AGHAYAN HAMIDREZA, MOHAMADI JAHANI FERESHTEH, PAYAB MOLOUD, RAHIM FAKHER, LARIJANI BAGHER, Tayanloo Beik Akram, Adibi Hossein, ARJMAND BABAK. GMP-Compliant Human Fetal Skin Fibroblasts forWound Healing. ARCHIVES OF NEUROSCIENCE[Internet]. 2018;5(3):0-0. Available from: https://sid.ir/paper/354693/en

    IEEE: Copy

    PARISA GOODARZI, KHADIJEH FALAHZADEH, HAMIDREZA AGHAYAN, FERESHTEH MOHAMADI JAHANI, MOLOUD PAYAB, FAKHER RAHIM, BAGHER LARIJANI, Akram Tayanloo Beik, Hossein Adibi, and BABAK ARJMAND, “GMP-Compliant Human Fetal Skin Fibroblasts forWound Healing,” ARCHIVES OF NEUROSCIENCE, vol. 5, no. 3, pp. 0–0, 2018, [Online]. Available: https://sid.ir/paper/354693/en

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