Clinical Research Directory

Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo

This study evaluates whether exosomes derived from human umbilical cord mesenchymal stem cells (hUMSCs-Exo) are safe and effective for treating vitiligo in adults. Vitiligo is a skin condition that causes white patches due to loss of pigment-producing cells. Current treatments have limitations, especially for patients with active disease who require oral steroids with significant side effects. This study is a single-center, randomized, controlled trial enrolling 96 adults aged 18 to 65 years with non-segmental vitiligo. Participants are divided into two groups based on disease activity: progressive vitiligo (new patches appearing or existing patches expanding in the past 3 months) and stable vitiligo (no changes in the past year). For progressive vitiligo, participants are randomly assigned to either: Experimental group: hUMSCs-Exo given by intravenous infusion every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: oral prednisone (a standard steroid treatment) plus tacrolimus ointment and narrowband UVB light therapy For stable vitiligo, participants are randomly assigned to either: Experimental group: hUMSCs-Exo given by local injection into the white patches every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: tacrolimus ointment plus narrowband UVB light therapy alone The treatment period lasts 12 weeks, with follow-up visits continuing to 24 weeks. The main outcome measures include improvement in skin repigmentation measured by the Vitiligo Area Scoring Index (VASI), changes in quality of life, and safety monitoring throughout the study. This study aims to establish a standardized approach for using hUMSCs-Exo in vitiligo treatment and to explore how exosomes may work by reducing oxidative stress and regulating immune responses.

Clinical Study on the Effect of Umbilical Cord Mesenchymal Stem Cell Exosomes on Endometrial Repair of Intrauterine Adhesions

Intrauterine adhesions (IUA) is a group of diseases caused by endometrial injury leading to occlusion of the uterine cavity and serious abnormality of the uterine cavity morphology, which causes primary or secondary infertility by affecting embryo implantation. At present, the poor effectiveness of clinical treatment methods has made the thin endometrium after intrauterine adhesions an urgent problem to be solved in the clinical field of assisted reproduction. Stem cells with multi-directional differentiation potential provide a new idea for the treatment of cervical adhesions. However, due to limitations such as stem cell extraction, technical conditions, and ethical issues, clinical application cannot be widely carried out. Exosomes are vesicle structures produced by paracrine secretion of cells, containing abundant proteins, RNA, etc., and mediating information exchange between cells. Recent studies have found that stem cells play a role in tissue repair mainly through paracrine, and stem cell-derived exosomes have similar functions to stem cells. Human cord mesenchymal stem cells were selected as an intervention for this clinical study because of their wide source, easy access, and low immunogenicity. Therefore, in this clinical study, the investigator will evaluate the clinical safety and efficacy of infusing human umbilical cord mesenchymal stem cell exosomes into the uterine cavity for the treatment of thin endometrium after intrauterine adhesions.

Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer

Circulating tumor DNA (ctDNA) offers the possibility of accessing the tumor genome from circulating blood through a simple blood test. It is currently used for diagnostic, prognostic and predictive purposes of response or resistance to oncological treatments. These advances in ctDNA have been made possible by major developments in molecular biology techniques in recent years, as the detection of ctDNA requires very sensitive techniques such as Next Generation Sequencing (NGS). CtDNA overcomes this problem of very limiting tumor heterogeneity during a solid biopsy. All of these applications make circulating DNA an increasingly essential tool in the management of cancer patients. The studies are currently in most cases on small numbers and are retrospective. In addition, exosomes are also a biomarker of the future that can also be detected in the bloodstream . Exosomes are nanovesicles 50 to 200 nm in diameter released into the extracellular environment via the endosomal pathway by fusion with the plasma membrane. They are very informative since they transport tumor genetic material in the form of DNA, mRNA and miRNA, but also adhesion proteins, immunostimulatory molecules and cytoskeleton, enzymes and Heats shock proteins ( HSP). The aim of the ADIGYN study is to set up a large prospective cohort to assess the diagnostic, prognostic and predictive impact of ctDNA and exosomes in digestive and gynecological / breast cancers. From the circulating DNA, we characterize the ActDNA on the molecular level thanks to the study of different point mutations usually used but also of new described mutations having a therapeutic impact and the search for other genetic alterations having an impact on the therapeutic strategy (such as microsatellite instability) or the study of exosomes and their composition. To assess resistance to oncological treatments, ctDNA will be analyzed at the start of treatment, during treatment, during progression and / or relapse and also during monitoring or treatment break

ExoLuminate Study for Early Detection of Pancreatic Cancer

ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC). Those with elevated risk for PDAC can include individuals with intraductal papillary mucinous neoplasms, family history of pancreatic cancer, germline mutations in genes known to be associated with cancer, and a personal or family history of pancreatitis. The goal of the study is to compare the performance of ExoVerita™ assay in early detection of PDAC to current standard-of-care methods of surveillance.

Prognostic Study of Via Dynamic Change of PCA3 mRNA in Drainage Fluid After Radical Prostatectomy

This study investigates the prognostic value of dynamic changes in PCA3 mRNA levels found in the abdominal cavity drainage fluid after radical prostatectomy. Prostate cancer is one of the most common cancers in men, and radical prostatectomy is a standard treatment. While PSA levels in the blood are commonly used as a marker for diagnosis, this study focuses on the significance of PCA3 mRNA levels in the prognosis of prostate cancer. The findings may provide insights into improved post-surgical monitoring and more tailored therapeutic strategies for prostate cancer patients.

Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity

Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs.