GMP-Compliant Human Fetal Skin Fibroblasts for Wound Healing

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.

Retrospectives on Three Decades of Safe Clinical Experience with Allogeneic Dermal Progenitor Fibroblasts: High Versatility in Topical Cytotherapeutic Care

“…Therefore, recent research directions under the Swiss progenitor cell transplantation program have comprised the development of ancillary components or processing methods, aiming mainly to fight infectious risks in burn patient populations, as well as to provide improved, stable, and safe cytotherapy-inspired derivative products. Key considerations shaping and orienting the next steps in therapy development have been cell source processing, clinical administration modalities, and the use of cell-derived cell-free biological materials, to cite only a few recent scientific and technical areas of focus [ 49 , 50 , 51 , 52 , 53 , 54 , 55 ]. It is noteworthy that many groups have lately been investigating cell sources similar to those discussed herein for therapeutic use, at various stages of theoretical work, applied research, or preclinical development [ 55 , 56 , 57 , 58 , 59 ].…”