Gastric reflux: the therapeutical role of Marial® .

The worldwide relevance of gastroesophageal reflux disease (GERD) has had a considerable increase in recent years. The guidelines for the diagnosis and treatment of GERD are well consolidated and continuously updated. Recently, the extra-esophageal manifestations of reflux have been considered from a multidisciplinary point of view, so the symptoms of the laryngo-pharyngeal reflux (LPR) have been precisely defined. At present, a new Medical Compound (Marial®) has the indication for the treatment of both GERD and LPR. Clinical experience has initially confirmed its effectiveness in both disorders.

Photobiomodulation in the treatment of chronic non-responding wounds.

We present a protocol of care and therapeutic approach to skin lesions, called AIMED (Anti Inflammatory Regenerative Medicine), which is based on the circularity of its phases and applied therapeutic methodologies. We used photobiomodulation (PBM) for the examination non-responding skin lesions. PBM is an adjuvant treatment for the stimulation of regenerative cellular processes, reduction of inflammation and pain and biochemical modulation of molecular response. We used PBM for the examination of skin lesions, which were not responding to other therapies. LumiHealTM protocol treatment has been applied for 3 months on 8 patients affected by infected vascular ulcers of the lower limbs resistant to previous treatments. Three patients reached positive results immediately, and the remaining 5, at the first follow-up. The use of LumiHealTM in combination with other treatments, method allowed an effective and rapid improvement of the lesions via modulation of the immune response.

Regenerative medicine in the treatment of gastro-esophageal reflux disease and laryngo-pharyngeal reflux. From research to cure.

We present our observational study on 40 patients treated with the medical device containing sodium hyaluronic acid and magnesium alginate, performing a lubricating and hydrating action. This device is in the form of a gel, with topical action to contrast gastroesophageal reflux and to exert a mechanical role of protection of the mucosal tissues (mouth-pharyngo-esophageal mucosa and gastric mucose.). Forty patients were recruited aged between 22- and 72-years-old with painful dyspeptic Gastro Esophageal Reflux Disease (GERD) symptomatology in acute or in clinical phase (25 patients) and with pharyngolaryngo- tracheal symptomatology (15 patients). Patients were divided into two clinical groups: Group A was treated with the medical device, while Group B with conventional treatments without the medical device. Subjects of both groups were also treated with proton pump inhibitors (PPIs). Follow-up was at 10, 20 and 30 days and patients were evaluated for reduction of their subjective symptoms, reduction of symptomatic and occasional therapies, reduction of inflammatory process or disappearance of epithelial lesions of the examined mucosa, healing process. The reduction of subjective symptoms was observed at 10 days in the patient with food bolus (disappearance after 5 days) and in patients with a reduction of 70%. A relevant reduction in the use of symptomatic drugs was noted. Our data are relevant considering symptom relief (heartburn, reflux and dyspepsia). New scenarios for the treatment of inflammatory diseases of the digestive and respiratory tract mucosa are at the horizon. Interdisciplinary translational research brings to the development of novel medical devices (as the one described in this study) with a high safety profile, and extremely active on the inflammation-repair-regeneration complex of different tissues and organs.

Photobiomodulation with polarized light in the treatment of cutaneous and mucosal ulcerative lesions.

In recent decades, regenerative medicine has achieved an important evolution at both a conceptual level and scientific production, which explains the current and future possibilities of therapy and daily clinical practice. The main aim of regenerative medicine is the complex system of repair/regeneration. The current literature on the subject demonstrates the advantage of visible light therapy for skin injuries and diseases with the photobiomodulation in which light at low energy levels modulates intra- and extra-cellular photoreceptors by molecular and cellular processes that can stimulate both anti-inflammatory mechanisms and cell proliferative response. The irradiation effects are activated soon after exposure. The anti-inflammatory action on some classes of cytokines and cells (e.g. mast cells and macrophages) is completed with the stimulation of the nitric oxide production, which has an anti-inflammatory and vasodilation action, and gives analgesic relief. Our attention focused on photobiomodulator medical device emitting polarized light. 30 patients (19 women and 11 men) were enrolled in the present study. They were treated for chronic lesions using Bioptron® Light Therapy System device. Patients were initially subjected to Bioptron® light for 20 min after cleansing of the lesion. The operating protocol provides 24 sessions: twice per week for 12 weeks. Twenty patients have been studied for symptoms, histological samples and ulcer characteristics. After 2 months, a reduction of 50% of the lesions was recorded in 18 patients (60%), while in the remaining patients a slower healing was observed. The total wound healing was achieved after 3 months in 13 patients (43%). The examined parameters of the symptom were exudation, pain and signs of infection. Results at 1 and 3 months were, Exudation: at 1 month reduction and positive modulation was observed in 16 patients (53%) and in 25 patients at 3 months; Pain: (evaluated with Vas scale), decreased in 21 patients at 1 month (70%) and in 100% of cases at 3 months; Infections: regressed or disappeared in 100% of cases after the first month. Today, it is no longer time for monotherapy applications, especially in regenerative medicine and the adoption of biophysical therapies can play a positive anti-inflammatory and regenerative role enhancing the function of non-invasive therapies.

Chronic inflammation therapy combined with low dose cytokines in the treatment of chronic ulcers of lower limbs.

Prevalence of chronic venous leg ulcers has increased from 55% to 75% in 10 years. We treat chronic vascular lesions according to a cyclic multiphase method that follows the instrumental and differential etiologic diagnosis of ulcers of the lower limbs. The AIMED (Anti Inflammatory Regenerative Medicine) operating model follows the diagnostic phase and is structured in 5 interconnected phases. Mare evaluation, pH control, biofilm removal and prevention and infections are approached according to the International Guidelines. Low-dose cytokine therapy to contrast the inflammatory process are administrated to the patients. Chronic skin lesions of these patients, treated according to the AIMED protocol, have been evaluated twice a week. The clinical evaluation parameters evaluated by us were: reduction of pain at 15 and 30 days, reduction of 50% of the injury at 30 days, characteristics of perilesional skin (edema, erythema) and global profile of the patient. The so-called Low Dose Cytokines therapy is changing the previous therapeutic algorithms thanks to a safe and effective systemic cytokines-receptors interactive physiological process.

Electromagnetic field in control tissue regeneration, pelvic pain, neuro-inflammation and modulation of non-neuronal cells.

In scientific literature, magnetic fields are used both in basic science and clinical research. They are often used to treat pain and neuro-inflammation disorders thanks to their influence on cellular responses. Our project was born from the regenerative support that we wanted to give to those diseases characterized by neuro-inflammation, nerve lesion, muscles and tissues disorders that can transform the symptom (e.g. neuropathic pelvic pain) in disease. In this study, we examined the action of pulsed electromagnetic fields (PEMFs) on skin lesion regeneration and the repetitive trans-pelvic magnetic stimulation (rTPMS) on patients affected by incontinence and post-surgical problems, sexual dysfunction, and pelvic pain. In rTPMS for post-surgery urinary incontinence, 40 patients affected by post-surgery urinary incontinence were enrolled. Twenty patients (post-prostatectomy) were treated with rTPMS and 20 with conventional therapies. In PEMF for the regeneration of skin tissue, 50 patients affected by various types of skin lesions (70% low legs vascular lesions) were treated with pulsed electromagnetic fields (PEMFs) twice per week and subsequently with home treatment (Home Care device) twice per day. In rTPMS study, results were evaluated after 3 months. In 10 patients (7 post prostatectomy, 3 cystourethrocele) which were submitted to 18 sessions, twice a week, an improvement of incontinence in 75% of cases with patient compliance was recorded and the quality of life up to 100% also improved. Utilizing PEMFs for the regeneration of skin tissue, following 3 months of AIMED protocol treatment, we reached a reduction of 50% of lesion area in the 60% of cases; 35% of cases healed completely. The use of rTPMS allows training muscles to adequately respond to inflammatory stimulus that causes muscle accommodation deficits with altered contractility or spastic painful contracture in pelvic district. It also stimulates a series of regenerative phenomena due to the action of magnetic waves at high intensity on cellular membrane and cytoplasm, especially on mast cells, which seem to have a fundamental role in the determination of the pelvic r egion pain. The magnetic fields for the treatment of cutaneous lesions, which are applied cyclically with other operating methods of AIMED protocol, confirmed the literature data, with a treated group of 50 patients. The use of magnetic fields opens new scenarios for regenerative medicine, since the cell could lend itself to a self-healing process if it receives specific information.