A randomized, double-blind, phase I clinical trial of fetal cell-based skin substitutes on healing of donor sites in burn patients

Momeni, Maryam; Fallah, Nasrin; Bajouri, Amir; Bagheri, Tooran; Orouji, Z; Pahlevanpour, Parisa; Shafieyan, Saeed; Sodeifi, Niloofar; Alizadeh, Ahad; Aghdami, Nasser; Fatemi, Mohammad Javad

doi:10.1016/j.burns.2018.10.016

Cited by 25 publications

(31 citation statements)

References 26 publications

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“…Wound size and wound healing time were reported to be significantly reduced in treated patients. Another study demonstrated the efficacy of fetal fibroblast-based skin substitutes in patients with burn wounds [80].…”

Section: Clinical Advancement Of Skin Equivalents In Wound Healing Therapiesmentioning

confidence: 99%

Advances in generation of three-dimensional skin equivalents: pre-clinical studies to clinical therapies

Choudhury

Das

2021

Cytotherapy

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The inability of two-dimensional cell culture systems to adequately map the structure and function of complex organs like skin necessitates the development of three-dimensional (3D) skin models. A diverse range of 3D skin equivalents have been developed over the last few decades for studying complex properties of skin as well as for drug discovery and clinical applications for skin regeneration in chronic wounds, such as diabetic foot ulcers, where the normal mechanism of wound healing is compromised. These 3D skin substitutes also serve as a suitable alternative to animal models in industrial applications and fundamental research. With the emergence of tissue engineering, new scaffolds and matrices have been integrated into 3D cell culture systems, along with gene therapy approaches, to increase the efficacy of transplanted cells in skin regeneration. This review summarizes recent approaches to the development of skin equivalents as well as different models for studying skin diseases and properties and current therapeutic applications of skin substitutes.

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Section: Clinical Advancement Of Skin Equivalents In Wound Healing Therapiesmentioning

confidence: 99%

Advances in generation of three-dimensional skin equivalents: pre-clinical studies to clinical therapies

Choudhury

Das

2021

Cytotherapy

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“…With the advancement of culture techniques and ability to isolate dermal fibroblasts, clinical studies have evaluated the use of CDSs for the treatment of chronic skin ulcers (7 of 10 studies), surgical wounds and burns (Table 3 ) 55 , 60 – 68 . Important findings from these studies highlight the release of cytokines or growth factors, which activates many pathways for skin regeneration 60 , 63 .…”

Section: Human Adult Skin Cells In Tesssmentioning

confidence: 99%

Cellular human tissue-engineered skin substitutes investigated for deep and difficult to heal injuries

et al. 2021

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Wound healing is an important function of skin; however, after significant skin injury (burns) or in certain dermatological pathologies (chronic wounds), this important process can be deregulated or lost, resulting in severe complications. To avoid these, studies have focused on developing tissue-engineered skin substitutes (TESSs), which attempt to replace and regenerate the damaged skin. Autologous cultured epithelial substitutes (CESs) constituted of keratinocytes, allogeneic cultured dermal substitutes (CDSs) composed of biomaterials and fibroblasts and autologous composite skin substitutes (CSSs) comprised of biomaterials, keratinocytes and fibroblasts, have been the most studied clinical TESSs, reporting positive results for different pathological conditions. However, researchers’ purpose is to develop TESSs that resemble in a better way the human skin and its wound healing process. For this reason, they have also evaluated at preclinical level the incorporation of other human cell types such as melanocytes, Merkel and Langerhans cells, skin stem cells (SSCs), induced pluripotent stem cells (iPSCs) or mesenchymal stem cells (MSCs). Among these, MSCs have been also reported in clinical studies with hopeful results. Future perspectives in the field of human-TESSs are focused on improving in vivo animal models, incorporating immune cells, designing specific niches inside the biomaterials to increase stem cell potential and developing three-dimensional bioprinting strategies, with the final purpose of increasing patient’s health care. In this review we summarize the use of different human cell populations for preclinical and clinical TESSs under research, remarking their strengths and limitations and discuss the future perspectives, which could be useful for wound healing purposes.

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“…Cell Therapies for Cutaneous Regenerative Medicine Sub-optimal pharmacotherapeutic management of severe and complex cutaneous affections and complications (e.g., chronic ulcers, burns, donor-site wounds) has prompted the development of numerous skin graft solutions (e.g., amniotic membrane, cadaver grafts, fish skin), innovative bioengineered cellular therapy solutions (e.g., cultured autografts), or autologous and allogenic cell-based products (e.g., Allox R , Apligraf R , Epicel R , Lyphoderm R , OrCel R , ReCell R , TransCyte TM ) that complement surgical care and support tissue structural integrity and functional recovery (Lukish et al, 2001;Limat and Hunziker, 2002;Kumar et al, 2004;Amani et al, 2006;Hartmann et al, 2007;Zaulyanov and Kirsner, 2007;Akita et al, 2008;Hirt-Burri et al, 2008b;Guerid et al, 2013;Zuliani et al, 2013;Malhotra and Jain, 2014;Tan et al, 2014;Debels et al, 2015;Akershoek et al, 2016;Abdel-Sayed et al, 2019b;Lima-Junior et al, 2019;Momeni et al, 2019;Climov et al, 2020). Further optimization of biological starting materials for such advanced solutions may primarily benefit FIGURE 5 | Differential overview highlighting the similarities and differences between stem cells and primary FPC types.…”

Section: Swiss Multi-tiered Biobanking Model For Primary Fpcsmentioning

confidence: 99%

Holistic Approach of Swiss Fetal Progenitor Cell Banking: Optimizing Safe and Sustainable Substrates for Regenerative Medicine and Biotechnology

Laurent

Hirt‐Burri

Scaletta

et al. 2020

Front. Bioeng. Biotechnol.

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Swiss Fetal Progenitor Cell Banking is proposed, achieving sustained standards and potential production of billions of affordable and efficient therapeutic doses. Thereby, the aim is to validate the core therapeutic value proposition, to increase awareness and use of standardized protocols for translational regenerative medicine, potentially impacting millions of patients suffering from cutaneous and musculoskeletal diseases. Alternative applications of FPC banking include biopharmaceutical therapeutic product manufacturing, thereby indirectly and synergistically enhancing the power of modern therapeutic armamentariums. It is hypothesized that a single qualifying fetal organ donation is sufficient to sustain decades of scientific, medical, and industrial developments, as technological optimization and standardization enable high efficiency.

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A randomized, double-blind, phase I clinical trial of fetal cell-based skin substitutes on healing of donor sites in burn patients

Cited by 25 publications

References 26 publications

Advances in generation of three-dimensional skin equivalents: pre-clinical studies to clinical therapies

Advances in generation of three-dimensional skin equivalents: pre-clinical studies to clinical therapies

Cellular human tissue-engineered skin substitutes investigated for deep and difficult to heal injuries

Holistic Approach of Swiss Fetal Progenitor Cell Banking: Optimizing Safe and Sustainable Substrates for Regenerative Medicine and Biotechnology

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