Active clinical trials for "Autoimmune Diseases"

To determine the effectiveness of a 7-day course of an oral, prophylactic antibiotic on the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.

Investigators aim to develop an effective and safe treatment of autoimmune diseases through adoptive T regulatory cells transfer. Our objectives are to evaluate the safety and efficacy of autologous adoptive Treg (CD4CD25FoxP3 CD127 low regulatory) cell transfer to patients with refractory autoimmune diseases: Refractory lupus Nephritis, and adults' type1 diabetes mellitus. Patients and Methods: This is Non randomized open label phase 1 pilot study including ten patients with refractory lupus nephritis and ten patients with Type 1 diabetic patients. All patients will be subjected to Full history taking, clinical examination and pretreatment investigations according to the type of autoimmune disease then regulatory T cells (Tregs) identification and count, Treg isolation and expansion and finally administration of T reg cells and follow-up of adverse events and outcomes.

A study to quantify changes in motor performance of epidural stimulation in progressive multiple sclerosis (MS) patients over the course of 12 rehabilitation sessions.

This is a patient research registry aimed at evaluating the effectiveness of a comprehensive, root-cause medical approach ("AndHealth program") for autoimmune disorders. This approach involves a combination of pharmacological and non-pharmacological therapies offered under the care of a licensed physician with the support of health coaches. While protocol guidance is provided, the therapeutic approach is personalized to the individual needs of patients. The autoimmune disorders of focus in this registry include rheumatoid arthritis, psoriatic arthritis, psoriasis and ankylosing spondylitis. A variety of validated labs, patient-reported outcomes, and medication usage will be assessed among participating patients over a period of up to five years to evaluate the long-term effectiveness of this approach.

The goal of this observational study is to learn about fertility preservation for pre-pubertal, peri-pubertal, and adult participants that are unable to pursue clinical standard of care fertility preservation such as egg (oocyte) and embryo cryopreservation. In addition, this study will provide research tissue for the following Specific Aims: To optimize techniques for cryopreservation of ovarian tissues from patients at significant risk for infertility. To investigate factors affecting successful maturation ovarian tissue. Participants will undergo a surgical procedure to remove an ovary (oophorectomy) to preserve their gonadal tissue for fertility preservation.

A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single Oral Dose of LPX-TI641.

The objective of this work is to identify, in patients with autoimmune diseases, systemic vasculitis and autoinflammatory disease, cytokine and lymphocyte biomarkers of activity of these diseases to identify follow-up biomarkers, in order to personalize the follow-up and the treatments for each patient. Immunological data will be obtained from biological samples collected as part of the usual patient care pathway (Blood and tissues sampling) The study will take place in the Department of Internal Medicine and Clinical Immunology (DMIIC), that is certified as the National Reference Centre for Rare Systemic Autoimmune Diseases and the National Reference Centre for Inflammatory Autoinflammatory Diseases and Inflammatory Amyloidosis (CEREMAIA). Its objective is to contribute to the advancement of fundamental knowledge in immunology, in particular to develop prognostic biomarkers of the activity of autoimmune diseases, systemic vasculitis and autoinflammatory diseases by using blood tests.

Ocular surface disease, especially dry eye and scleritis, commonly affects patients with autoimmune diseases. Ocular surface immune cells are increased in autoimmune disease; however the full subset of immune cells activated is unknown. Recent experimental studies show that dendritic cells and T cells in the cornea are critically associated with corneal nerve innervation. Corneal confocal microscopy (CCM) allows rapid non-invasive in vivo imaging of dendritic cells and corneal nerves. The investigators propose to investigate how ocular surface health, conjunctival immune cells and corneal nerve/dendritic cell morphology interact in 3 rheumatological conditions: Sjogren's syndrome (SS), Rheumatoid arthritis (RA), Systemic lupus erythematosus (SLE). The preliminary flow cytometric studies show that various immune cells (eg: T cells, B cells, and dendritic cells) can be quantified using minimally invasive impression membranes (Eyeprim). Clinically, the research team is experienced in measuring features of ocular surface inflammation (conjunctival redness, tear breakup times) with Oculus keratograph5M. The investigators also aim to harvest conjunctival immune cells using impression cytology and quantify specific cell types with flow cytometry. Corneal nerve morphology and dendritic cell density and distribution will be assessed using CCM; in collaboration with the group who have pioneered this technique. The investigator anticipate that alterations in corneal nerve and dendritic cell parameters will correlate with immune activation/inflammation, deterioration of tear function and increased systemic severity of the rheumatological disease. In addition, the investigators hypothesize that the lower the corneal nerve density, the higher the number of corneal dendritic cells and conjunctival inflammatory cells. Studying these relationships may allow a better mechanistic understanding of local corneal and systemic immune activation and the development of a non-invasive ophthalmic surrogate marker of dendritic cell activation and nerve fibre loss to aid earlier diagnosis, risk stratification and the development of new therapies in autoimmune patients with severe dry eye.

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

The study team plans to establish a bioregistry of patients receiving biologic therapy as part of their standard treatment at the Mount Sinai Therapeutic Infusion Center and affiliated practices. The study team will to apply state-of-the-art approaches to assessing and predicting immunological and clinical responses associated with these standards and prescribed treatments. The approach is twofold. The first component is to establish a robust and flexible biorepository and database that includes demographic, immunologic, exposure and clinical records, and can facilitate research across disciplines, and across other registries affiliated with Mount Sinai. The second component is to address specific key research questions focused on using novel diagnostics to increase the effectiveness of biologic treatment. Most patients will be recruited from the Mount Sinai Therapeutic Infusion Center (TIC), although others receiving infusions elsewhere or at home will be recruited from outpatient Sinai affiliated clinical practices.