Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
NCT05148598 — Scleroderma, Diffuse
Status: Not yet recruiting
http://inclinicaltrials.com/scleroderma-diffuse/NCT05148598/
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
NCT05085444 — Autoimmune Diseases
Status: Recruiting
http://inclinicaltrials.com/autoimmune-diseases/NCT05085444/
Investigation of Upper Extremity Home Exercises Effects on Grip Strength, Range of Motion, Activity Performance and Funcionality in Patients With Scleroderma
Hand involvement in scleroderma leads to functional disability due to the relationship between grip strength, wrist and finger movement. The vast majority of patients report that their activities are restricted and their quality of life decreases for this reason. Literature indicate that more work is needed to continue to develop and evaluate rehabilitation interventions in this population. This study is a randomized controlled study examining the effects of 8 weeks of upper extremity home exercises on grip strength, normal joint movement, activity performance and functionality in patients with scleroderma. In our study, it is aimed to contribute to the standardization of upper extremity exercise protocols for scleroderma patients, to increase the quality of life of patients and to increase their independence in daily living activities.
NCT05080738 — Scleroderma
Status: Completed
http://inclinicaltrials.com/scleroderma/NCT05080738/
Physical Rehabilitation in Women With Scleroderma: Effects on Pulmonary Function, Lung Ultrasound, Muscle Function, Hand Functional, Functional Capacity, and Quality of Life
Scleroderma (or Systemic Sclerosis - SSc) is one of the most neglected diseases worldwide, according to the World Health Organization. In the adult population with SS, the systemic effects of the disease, such as respiratory and peripheral muscle dysfunction, cause a decrease in quality of life. As a consequence, there is a concern about functional rehabilitation, since the aging of this population is already a reality. Thus, the objective of this project is to evaluate the effects of functional rehabilitation on functional capacity and quality of life in women over 18 years of SS. In this longitudinal intervention study, patients will be submitted to a three-month rehabilitation program. Before and after the intervention, patients will be submitted to the following assessments: Cochin Hand Functional Scale (CHFS), Short-Form 36 Health Survey (SF-36); Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI); lung function; lung ultrasound; handgrip; Glittre Activities of Daily Living test. Thus, it is expected that patients with SS will benefit significantly, with a consequent improvement in musculoskeletal function and , functional capacity and health-related quality of life.
NCT05041868 — Quality of Life
Status: Recruiting
http://inclinicaltrials.com/quality-of-life/NCT05041868/
Identification of Biomarkers Associated With Disease Worsening Within 10 Years in Scleroderma Patients
Systemic sclerosis (SSc) is the most severe of the systemic autoimmune diseases. It is characterized by skin and organ fibrosis (mainly interstitial lung disease, which affects 40-50% of patients), as well as severe vascular complications such as pulmonary hypertension (5-10%), renal crisis (2%), and digital gangrene (5%). There are currently no validated prognostic biomarkers for the progression of SSc, yet it is crucial to better predict the progression of SSc to optimize patient management, but also to identify the optimal population for clinical trials ("progressor" patients). Furthermore, there are no validated biomarkers of response to immunosuppressive therapies that would be useful both in patient management and in the evaluation of new treatments in clinical trials. The internal medicine department of the Lille University Hospital is a national and European reference center for the management of patients with SSc. Nearly 500 patients are followed annually in the internal medicine department. As part of their routine care, patients are hospitalized in average once a year in the internal medicine department of the Lille University Hospital for a complete assessment of their SSc. This assessment includes a detailed medical observation, complementary examinations and blood and urine biology tests. The purpose of this study would be to collect 2 additional blood samples during the standard evaluation of scleroderma patients. The main objective of this collection of biological samples for scientific research will be the identification of new biomarkers associated with prognosis and treatment response to improve the management of SSc patients.
NCT04986514 — Systemic Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/systemic-sclerosis/NCT04986514/
UVA-1 for Treatment of Skin Tightening and Improvement of Hand Function in Scleroderma: a Randomized, Intra-patient, Dominant/Non-dominant Hand Clinical Trial.
UVA-1 has been reported to be beneficial to skin changes in scleroderma in several case reports and a few small studies. (Jacobe 2020) Interpretation of these reports has been difficult based on the small numbers of subjects involved and the non-blinded non-randomized nature of the reports. In a single controlled study with half-side comparison of 9 patients, the investigators could not demonstrate improvement with UVA-1 in the treated hand. (Thomas 2007) This study was limited by a small number of patients and the long disease duration prior to treatment (mean of 13 years). A more recent report of a patient with scleroderma for 2.5 years and severe acrosclerosis that responded to 21 sessions of UVA-1 with improved mobility and functionality renews interest in this treatment modality. (Cuenca-Barrales 2019) In this trial patients will be randomized to have their dominant or non-dominant hand undergo 30 sessions of UVA1 therapy . We will assess patient's hand mobility, hand function, skin hardening (assessed by durometer measurements), skin thickness, as well as patient reported outcomes to determine efficacy. This study will use a single-blind, prospective, randomized (dominant/non-dominant hand) comparator design to assess the effect of high dose (80-120 J/cm2) UVA1 therapy on hand function in scleroderma in a paired t-test design. This study will be placebo-controlled (with a UV-blocking gloved hand), cross-over, randomized clinical trial. Following the initial treatment period (30 treatments), patients will have the option to undergo the same high dose UVA1 treatment protocol on the untreated control hand. A follow up period of 12 months following completion of UVA1 therapy will prospectively follow patients to monitor for relapse of their disease to assess the durability of the clinical response to UVA1 therapy on hand scleroderma.
NCT04875078 — Scleroderma
Status: Enrolling by invitation
http://inclinicaltrials.com/scleroderma/NCT04875078/
A Phase 2 Open-Label Pilot Study of the Safety and Tolerability of Ixazomib Administered Orally to Patients With Scleroderma-Related Interstitial Lung Disease
The purpose of this research study is to learn about the effects of the medication ixazomib in participants with scleroderma/systemic sclerosis including its safety and tolerability, its effects on skin, lungs and other organs, and its effects on overall health and quality of life.
NCT04837131 — Systemic Sclerosis
Status: Terminated
http://inclinicaltrials.com/systemic-sclerosis/NCT04837131/
Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma
- Few data are available on scalp involvement in systemic scleroderma. - Few data are available on the association between scalp abnormalities and features of systemic scleroderma - Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice - There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma The objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma
NCT04804930 — Scleroderma, Systemic
Status: Recruiting
http://inclinicaltrials.com/scleroderma-systemic/NCT04804930/
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
This is a Phase II randomized, double-blind, placebo-controlled trial of sildenafil in men and women with Scleroderma with mildly elevated pulmonary pressures (SSc-MEP) to determine whether sildenafil may be an effective treatment for SSc-MEP.
NCT04797286 — Scleroderma
Status: Recruiting
http://inclinicaltrials.com/scleroderma/NCT04797286/
Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma
Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin
NCT04746313 — Scleroderma
Status: Recruiting
http://inclinicaltrials.com/scleroderma/NCT04746313/