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Graft vs Host Disease clinical trials

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NCT ID: NCT06423131 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT

Start date: May 26, 2024
Phase: N/A
Study type: Interventional

This is a single-center prospective, non-randomized controlled clinical study in China using CliniMACS TCRα/β+ cell depleted stem cell haploidentical donors versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplantation in children.

NCT ID: NCT06348602 Recruiting - Clinical trials for Ocular Graft-versus-host Disease

Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT

Start date: August 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Chronic GVHD (cGVHD) is a predominant cause of mortality and disability not related to relapse; it occurs in 30 to 70% of patients. The majority of patients with cGVHD present with ocular involvement with a reported incidence of 40-60%. Symptoms can range from mild dry eye syndrome to severe epithelial defects that can generate corneal perforation and loss of vision. The most accepted pharmacological modality is the topical application of cyclosporine A; on the other hand, tacrolimus has shown greater immunosuppressive power when used in ocular GVHD. However, this effectiveness is limited since by the time the manifestations appear, there is already permanent damage to the lacrimal gland due to the lymphocytic infiltration; so it is necessary to use a prevention strategy before these manifestations appear. Previously, the employment of ocular cyclosporine drops as ocular GVHD prophylaxis was assessed to evaluate safety and effectiveness, showing that it is well tolerated and can limit the appearance of severe dry eye manifestations in a small group of patients. The purpose of this work is to compare the two modalities currently accepted for the treatment of the disease, but in a prophylactic way; topical ciclosporin A against topical tacrolimus, to determine the safety and efficiency of each of them as a preventive measure to limit the risk of developing the appearance of ocular cGVHD and the permanent consequences that this generates.

NCT ID: NCT06321198 Recruiting - Clinical trials for Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)

A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD

Start date: February 10, 2024
Phase: N/A
Study type: Interventional

A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD

NCT ID: NCT06321003 Recruiting - Oral Cancer Clinical Trials

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

SYMILIS OCT
Start date: March 13, 2024
Phase:
Study type: Observational

This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features. The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC. Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods. In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.

NCT ID: NCT06300320 Recruiting - Clinical trials for Chronic Graft Versus Host Disease

A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

Start date: May 7, 2024
Phase: Phase 2
Study type: Interventional

This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease

NCT ID: NCT06247150 Recruiting - Clinical trials for Chronic Graft Versus Host Disease

Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)

TIL-GVHD
Start date: May 21, 2024
Phase: N/A
Study type: Interventional

Graft versus Host Disease (GVHD) is frequent after allogeneic stem cell transplantation (alloSCT). GVHD occurs following 2 patterns : acute GVHD (aGVHD) or chronic GVHD (cGVHD). The latter occurs in nearly 50% of patients and its pathogenesis remains poorly understood. Previous translational studies have delineated biological immune dysregulation involved in cGVHD and facilitated the development of new drug and therapeutic strategies. New aspects of T and B cells collaboration in the context of cGVHD using blood description of a key player called TFH, classicaly involved in germinal center reaction, were previously uncovered (Forcade et al, Blood 2016). Previous studies in the context of auto-immune inflammation (lupus nephritis) or organ transplant rejection, suggested that target tissue could contain accessory lymphoid structures (TLS). The description of such structures in cGVHD target tissue would give the opportunity to directly analyze immune key player involved the pathogenesis of cGVHD.

NCT ID: NCT06200441 Recruiting - Clinical trials for Endothelial Dysfunction

Correlation of Serum Gasdermin-D and NLRP-3 Inflammasome Levels With GVHD Biomarkers and Endothelial Damage Markers in Graft-Versus-Host Disease

Start date: November 15, 2023
Phase:
Study type: Observational [Patient Registry]

The investigators aimed to reveal the relationship between serum markers of pyroptosis, GVHD biomarkers and endothelial damage markers in patients who were planned for allogeneic stem cell transplantation for AML and developed GVHD during follow-up. Secondary outcomes of the study were to demonstrate the role of pyroptosis in the pathophysiology of GVHD and transplantation-associated endothelial injury using serum plasma samples; the efficacy of GVHD biomarkers used to demonstrate organ-specific involvement; and the efficacy of GVHD biomarkers and endothelial injury markers in predicting the development of GVHD, transplantation-associated endothelial injury and non-relapse mortality.

NCT ID: NCT06186804 Recruiting - cGvHD Clinical Trials

A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)

Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, single arm, open label phase II clinical study in China. This study will evaluate the efficacy and safety of ABSK021 (Pimicotinib) in the treatment of patients with cGvHD who failed first-line therapy.

NCT ID: NCT06160986 Recruiting - Quality of Life Clinical Trials

Horizons Chronic Graft-Versus-Host-Disease Study

Start date: December 27, 2023
Phase: N/A
Study type: Interventional

This research is being done to evaluate the feasibility of the Horizons Program, a group-based behavioral intervention, to enhance quality of life in patients with chronic graft-versus-host disease.

NCT ID: NCT06149832 Recruiting - Clinical trials for Mesenchymal Stem Cells

Treatment of Oral Chronic Graft-versus-host Disease With Human Umbilical Cord Mesenchymal Stem Cell Dressing

Start date: November 30, 2023
Phase: Phase 4
Study type: Interventional

Chronic graft-versus-host disease (cGVHD) is a clinicopathological syndrome caused by donor lymphocytes attacking the recipient's organs during the process of reestablishing donor immunity after allogeneic hematopoietic stem cell transplantation (allo-HSCT), with an incidence of about 30%-70%. The clinical manifestations of cGVHD are varied, the course of the disease is prolonged, and the quality of life of patients is affected, and the long-term survival is affected. Among them, oral cGVHD is the most common type, which mainly presents with lichen planus, oral ulcers, mucosal atrophy, erythema and pain. At present, the treatment of oral cGVHD is based on systemic treatment and local hormone-containing gargling solution and local photochemotherapy. The former is easy to be complicated by oral local fungal infection, while the latter has no such equipment in China. Therefore, it is urgent to establish a simple, effective and low-toxicity local treatment for oral cGVHD. Mesenchymal stem cells (MSCs) are one of the most widely used cell products in clinic. The combination of MSCS and hematopoietic stem cells can improve the success rate of transplantation and accelerate hematopoietic reconstruction. The applicant team previously completed a national multi-center clinical study on MSCs prevention of cGVHD, which proved that sequential infusion of MSCs can effectively reduce the incidence of cGVHD, and the mechanism is that MSCs regulate Th1: Th2 balance and promote the differentiation of T cells to Th1 direction. Our previous mechanism study provides an important theoretical basis for MSCs treatment of oral cGVHD. According to the clinical needs and the rich experience of our research group in the field of MSCs clinical research, we plan to use dressing containing MSCs for the local treatment of oral cGVHD, so as to improve the lesion degree of oral cGVHD and improve the quality of life of allo-HSCT patients, and provide clinical experience for reference for the local treatment of MSCs graft-versus-host disease.