Randomized, double‐blind, placebo‐controlled, dose‐ ranging study of granulocyte‐macrophage colony stimulating factor in patients with chronic venous leg ulcers

Costa, Rafaela Lira Mendes; Jesus, Fernando Miguel; Aniceto, Cristina; Mendes, Mateus

doi:10.1046/j.1524-475x.1999.00017.x

Cited by 121 publications

(77 citation statements)

References 13 publications

(11 reference statements)

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“…Similarly, granulocyte macrophage colony stimulating factor (GM-CSF) has been also showed promising for wound treatment in vitro, mainly due to the stimulation of VEGF production [58]. Other studies have given encouraging results in clinical trials on patients with venous stasis ulcers [59] and diabetic-foot ulcers [60]. However, cytokines should not be considered individually, because in vivo they function in complex networks and cascades, frequently exhibiting antagonism (the effects of one cytokine may be inhibited by another cytokine).…”

Section: Growth Factors and Cytokinesmentioning

confidence: 99%

Polymers in Wound Repair

Francesko

Fernandes

Rocasalbas

et al. 2014

Advanced Polymers in Medicine

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Efficient dermal wound care implies providing a healing environment at the site of injury. Current repair techniques, including polymeric dressings, are able to accelerate only the healing of epidermal and partial thickness acute wounds based on maintaining the area moist. However, these are not efficient in treatment of full-thickness and chronic wounds, which lack in inborn regenerative elements and are highly prone to infections. For this reason the research interest is nowadays shifted towards functional biomaterials to tackle severe skin deteriorations by providing a beneficiary for healing pro-active and pathogen-free environment. Recent advances in molecular biology and materials science together with better understanding of wound pathophysiology allowed for designing of new wound care approaches that rely on biochemical stimuli to promote wound closure. Biopolymers that couple intrinsic antimicrobial and wound repair properties with hydrophilicity appear as suitable dressing platforms. These can be further upgraded using various bio-entities (therapeutic molecules, cells) with the ability to address specific targets in the biochemical environment of wounds in order to stimulate the healing process. This chapter summarises the abundant experimental and clinical data on polymers in advanced wound dressings, scaffolds for dermal regeneration and platforms for drug delivery.

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Section: Growth Factors and Cytokinesmentioning

confidence: 99%

Polymers in Wound Repair

Francesko

Fernandes

Rocasalbas

et al. 2014

Advanced Polymers in Medicine

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“…Sucralfate is a cytoprotective agent. It is a safe and well tolerated drug as demonstrated by the complete lack of side effects, and for this reason it is widely employed in clinical practice to prevent or treat several gastrointestinal diseases such as gastroesophageal reflux, gastritis, peptic ulcer, stress ulcer and dyspepsia, and in the treatment of recurrent aphthous stomatitis (12)(13)(14). Furthermore, the stimulating effects of sucralfate on vascular factors, including angiogenesis, which play important roles in tissue repair, have been demonstrated (15)(16)(17).…”

Section: Introductionmentioning

confidence: 99%

Topical treatment of chronic venous ulcers with sucralfate: A placebo controlled randomized study

Tumino¹,

Masuelli²,

Bei³

et al. 2008

Int J Mol Med

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Abstract. Venous leg ulcers are an important medical issue due to their high incidence in the elderly and the lack of a standard curative approach. Apart from surgical therapy, different medical treatments to effect ulcer wound repair and regeneration are currently being investigated. Sucralfate is a cytoprotective agent employed to prevent or treat several gastrointestinal diseases such as gastroesophageal reflux, gastritis, peptic ulcer, stress ulcer and dyspepsia. In this study we evaluated the efficacy, safety and tolerability of topical sucralfate (SUC-LIS 95) on the healing of chronic venous leg ulcers in 50 patients by a double-blind, placebo-controlled, randomized study. Our results indicated that the daily application of SUC-LIS 95 to non-infected post-phlebitis/vascular ulcers, for a median period of 42.0 days, led to complete healing in 95.6% of patients, against only 10.9% of cases with a matched placebo. A significant improvement was obtained in the SUC-LIS 95-treated patient group with regard to local tissue inflammation as well as pain and burning, and consequently, in ulcer size and the evolution of granulation tissue. Our findings were corroborated for selected patients by the morphological analysis of biopsies obtained before and after treatment. Using ultrastructural analysis we demonstrated that the topical use of SUC-LIS 95 was able to affect neoangiogenesis, increase wound contraction, promote re-epithelialization of the wound area and diminish the inflammatory reaction. Overall, our results indicated that patients with chronic venous ulcers show improvement after the use of topical sucralfate.

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“…While they are alive, allogeneic keratinocytes and fibroblasts cooperate to elaborate the growth factor GM-CSF, which is reported to influence the switch from pro-inflammatory M1 macrophages to pro-resolving M2 macrophages [37,38]. If the allogeneic cells can be made to die through apoptosis, for example by exposing them to gamma irradiation damage, engulfment of the apoptotic cells by macrophages can also suppress inflammation and activate resolution [39].…”

Section: Immunologic Considerationsmentioning

confidence: 99%

Human cell therapy for venous leg ulcers

Slade¹,

Jacobson²,

Lu³

2015

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Non-healing, chronic venous leg ulcers are sometimes mistakenly described as acute wounds that progress from hemostasis to inflammation but then become stuck in the inflammatory phase of healing. Typical explanations for this include colonization by bacteria, tissue infection, or the formation of bacterial biofilms. When standard care with debridement and compression bandaging fails to promote healing, therapeutic approaches shift to more aggressive surgical debridement, antimicrobial therapy, and the use of biological dressings or autologous grafts. A pathophysiologic view of persistent venous hypertension reveals the primary role of dermal inflammation, leading eventually to skin ulceration in a manner distinctly different from an acute wound. Subsequent to ulceration, additional inflammatory responses to invading pathogens can become important, but the underlying inflammatory state must be controlled before healing can take place, even with the use of skin grafts or cultured autologous skin cells. The prior belief that allogeneic keratinocytes and fibroblasts could engraft has given way to a more sophisticated consideration of the immunologic interplay between inflamed tissue and applied cells. This review briefly summarizes the history of cell therapy for venous leg ulcers, with a focus on concepts that have been tested in clinical trials, and a consideration of future development approaches.

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Randomized, double‐blind, placebo‐controlled, dose‐ ranging study of granulocyte‐macrophage colony stimulating factor in patients with chronic venous leg ulcers

Cited by 121 publications

References 13 publications

Polymers in Wound Repair

Polymers in Wound Repair

Topical treatment of chronic venous ulcers with sucralfate: A placebo controlled randomized study

Human cell therapy for venous leg ulcers

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