View clinical trials related to Scleroderma, Diffuse.
Filter by:The purpose of the study is to see how well reduced intensity conditioning followed by a stem cell transplant from a donor (allogeneic) works in treating patients with severe systemic sclerosis. In an allogeneic stem cell transplant procedure, stem cells are taken from a healthy donor and transplanted into the patient. Stem cells can be donated by a family member or an unrelated donor who is a complete tissue type match.
This will be a 36-week, randomized, double-blind, parallel group study comparing the effects of tadalafil monotherapy, ambrisentan monotherapy and combination therapy with tadalafil and ambrisentan in patients with PAH-SSc. Standard outcome measures such as six-minute walk distance (6MWD), NYHA classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo-placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
The safety and efficacy of vaccination against influenza in patients with scleroderma is not clear. The objective of this study is to assess its safety and efficacy in 50 patients with scleroderma in comparison with 30 controls
Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event and statins through their vasculoprotective effect might be of value in the treatment armamentarium of PAH related to SSc. The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.
This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have been resistant to multiple standard treatments. The underlying hypothesis is that the SSc condition is caused by an abnormal immune homeostasis that can be restored by MSCT.
The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.
The effect of deep oscillation and biofeedback on Raynaud`s phenomenon secondary to systemic sclerosis (SSc) remains to be determined. A prospective randomized controlled pilot study was performed in SSc patients receiving either deep oscillation, biofeedback thrice a week for four weeks or were randomized to the control group.
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-551 over escalating single doses in adult subjects with Scleroderma
To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.
Exercise-induced increase of the pulmonary arterial pressure may be an early sign of pulmonary arterial hypertension. It has been shown that patients with normal pulmonary arterial pressure at rest but elevated pulmonary arterial pressure during exercise have a decreased exercise-capacity and may have a worse prognosis compared to patients with normal pulmonary arterial pressure values at rest and during exercise. According to the currently used definition pulmonary hypertension can be diagnosed if the mean pulmonary arterial pressure is higher than 25mmHg at rest or 30mmHg during exercise. In this study patients with a risk for pulmonary arterial hypertension (connective tissue disease) and increased pulmonary arterial pressure values during exercise are receiving a therapy with a dual endothelin receptor antagonist - bosentan, a therapy established for pulmonary arterial hypertension. The therapy effect is than compared to the recorded changes before the introduction of this therapy.