15 Clinical Trials for Various Conditions
Graft microvascular inflammation poses a significant challenge to successful kidney transplantation due to its heterogeneous clinical presentation. There is a critical need to unravel the clinical significance of newly defined allograft microvascular inflammation phenotypes in the Banff 2022 classification and assess the implications of these new phenotypes on kidney transplant precision diagnostics and patient risk stratification.
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.
The purpose of this study is to evaluate the functional and clinical outcomes of patients receiving femoral condyle osteochondral allografts, to evaluate potential predisposing factors to failure of such grafts, and to compare the overall outcomes of the grafts to the current standard of care for smaller lesions, microfracture. Our hypothesis is that patients treated with these allografts will demonstrate significant functional improvement as measured by validated outcome scoring measures and their function will be at least equal to that of microfracture outcomes.
Every year in the US, there is a shortage of many thousands of kidneys needed for transplant. Furthermore, kidneys that are available and are transplanted often exhibit delayed or slow graft function (DGF and SGF, respectively), which lowers quality of life for patients and their families and requires significant additional medical care. These needs result in significant but preventable human suffering and health care spending. To address these needs, the investigators' project will test the use of intensive insulin therapy (IIT) in donors after neurological determination of death (DNDDs) as an intervention that will decrease acute kidney injury and improve renal function at the time of organ recovery. This should translate into a decreased incidence of DGF and SFG in recipients receiving organs from the IIT group. The investigators also expect to find a trend toward an increase in the number of organs available for transplant due to better organ protection in the DNDD. Taken together, these data can provide the requisite justification for a larger study that can be powered to evaluate the effect of IIT on increasing the number of kidneys available for transplantation. There is evidence that brain death often leads to hyperglycemia that may negatively impacts the organs of DNDDs. These observations led us to conduct a retrospective study, in which the investigators found that hyperglycemia in DNDDs is indeed associated with decreased terminal renal function. Because it has been reported that intensive insulin therapy (ITT) is renoprotective in the ICU more than conventional insulin therapy (CIT), the investigators propose to evaluate the use of IIT on DNDDs to: (1) improve organ function, (2) reduce DGF in recipients, and (3) possibly increase the number of kidney available for transplant. Methods: This is a prospective observational study to document the impact of IIT on acute kidney injury in DNDDS and on allograft function in recipients. DNDDs will be divided into two groups: CIT and IIT. In the first study, the investigators will evaluate the effect of ITT on biochemical parameters in blood samples that predict kidney health and function in DNDDs. All methods used in this proposal are well documented in the literature and established in the applicant's laboratory. In the investigators' second study, they will compare the effects of ITT in DNDDs on graft function in allograft recipients in terms of number of patients showing either DGF or SGF. Additionally, there is currently no established set of advanced biochemical criteria in DNDDs for predicting kidney function in recipients. The investigators will correlate the evaluated biochemical markers of kidney function and health in order to possibly develop more refined methods of predicting transplant success. Such a set of criteria would be useful for designing studies to systematically test additional interventions in DNDDs to further improve organ function before recovery and further increase the number of available organs. Taken together, the results of this study may lead to new therapies that significantly improve patient outcomes while significantly reducing disease associated costs. These results can also set the stage for a follow on study for increasing the number of kidneys available for transplant.
The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.
The goal of this observational study is to determine phenotypic, transcriptional, and epigenetic underpinnings of renal allograft rejection in renal transplant rejection. The main questions it aims to answer are: * To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in acute ejection. * To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. * To generate a scRNA sequencing (scRNAseq) map of the intra-graft immune cells and the renal parenchymal cells and compare the transcriptional and epigenetic changes within these cells in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. * To determine phenotypic changes associated with chronic rejection. Participants will be asked to provide the following research specimens: * Renal biopsy specimens at the following timepoints: day of transplantation (pre-implantation and post-perfusion); routine protocol biopsies at 3 months and 12 months; and clinically indicated for-cause biopsies at any timepoint from time-0 to 1-yr post-transplantation. The 1st research core will be used for routine histopathological examination and left over tissue from this core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The second research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. * Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). For each collection timepoint, up to 75 mL (about 5 tablespoons) will be collected. * Prospective clinical data and outcomes will be collected from participant medical records. * Follow-Up Period: For-cause biopsies from 1-yr to 5-yr post-transplantation (by the transplant nephrologist): no additional cores will be obtained for research from these biopsies. The left-over tissue from the clinically indicated biopsy cores will be analyzed by deep phenotyping and digital spatial profiling. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses).
The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF) surgeries. Patient participation is based on the physician determination that the patient requires one of these surgeries. Participants will be evaluated pre-operatively and post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to standard of care except for the completion of several study questionnaires: 1. Back Pain Questionnaire; 2. Oswestry Disability Index Questionnaire; 3. Short Form-36 (SF-36) Survey; 4. Visual Analog Pain Scale (VAS); and 5. The Modems Patient Satisfaction Survey. Outcome Measurements: 1. The patient's pain is scored by a VAS normalized to 100; 2. Patient function is based on Oswestry scores; 3. General health is assessed by SF-36 completion; and 4. Overall patient satisfaction will be determined by the completion of the Modems.
The MERCuRE (MEniscus, REstoration, Conservation, and Repair) group is embarking on a 20-year follow-up study to evaluate the clinical outcomes, graft longevity, and chondral protection following primary or revision Meniscal Allograft Transplantation surgery This clinical investigation is a prospective, primary observational, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on patients
Medication non-adherence is a major problem in kidney transplant recipients; young people 12-24 years of age are at particularly high risk for non-adherence and graft failure compared to young children and adults. Given that poor medication contributes greatly to graft failure, clinically feasible and effective interventions are urgently needed to improve adherence, survival, and quality of life in this population. The broad aim of this prospective, 3-stage, sequential study is to improve medication adherence in adolescent kidney transplant recipients by: 1) adapting the successful Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention for use in 'real world' clinical care, 2) designing and testing a new portable electronic pillbox and companion tracking website interface, and 3) preliminary testing of the adapted intervention.
Despite the considerable advances in short-term outcomes, kidney transplant recipients continue to suffer from late allograft failure, and little improvement has been made over the past 15 years. The worldwide scarcity of donated kidneys and the decline in the number of living donor transplants have prompted a variety of efforts to expand the organ supply, such as accepting organs from donors who were older or had comorbidities or other injuries. Two major initiatives from the United Network for Organ Sharing (UNOS), the organization responsible for organ allocation in the US, failed to improve the kidney acceptance rate. First, UNOS introduced the Kidney Donor Risk Index (KDRI) for all kidney offers in 2012. The KDRI is a score that predicts survival of deceased donor kidneys based on 10 donor characteristics and was intended to simplify the process of judging organ quality for clinicians. Second, in 2014, UNOS changed the kidney allocation system so that lower-quality kidneys are offered over wider geographic areas. Despite the ongoing severe organ shortage and these allocation initiatives, the number of discarded kidneys rose from 2,127 (14.9%) in 2006 to 3,631 (20%) in 2016. In this context, the experience of transplant programs outside the US could offer novel approaches to making organ utilization more efficient through the examination of the disposition of organs that are usually discarded in the US. This project aims: 1. To evaluate the potential benefit of transplanting kidneys that would have been discarded otherwise in the US 2. Computer simulation models on real life data to estimate the number of kidney transplants that would have taken place using data from a nationwide cohort study in two countries (France, the US); 3. To evaluate the potential gains in allograft survival years that would result in the US from a less restrictive kidney acceptance practice such as the one from France.
To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, clinical trials and clinical decision-making. Despite a clear pressing need, no population-scale prognostication system exists that will combine traditional factors and biomarker candidates to represent the complete spectrum of risk predicting parameters. To adequately predict transplant patients' individual risks of allograft loss, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, allograft precision phenotypes, ethnicity, immunosuppressive regimen monitoring, allograft infections, acute kidney injuries, and recipient immune profiles. This project aims: 1. To develop a generalizable, transportable, mechanistically and data driven composite surrogate end point in kidney transplantation; 2. To validate several risk scores to predict kidney allograft survival and response to treatment of individual patients; Eventually, it will provide an easily accessible tool to calculate individual patients' risk profiles after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.
The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.
Background: - Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. By studying the outcomes of kidney transplant in donors and recipients of African descent, researchers hope to better understand the effects of this genetic variation on the success of kidney transplants. Objectives: - To examine possible connections between genetic variations and kidney transplant outcomes for donors and recipients. Eligibility: * Participants in kidney transplant where both donor and recipient were of black African descent. * Eligible transplants include both living donor and deceased donor. Design: * The study will involve one visit of up to 8 hours. * All participants will provide a detailed personal and family medical history. * All participants will provide blood and urine samples, including a 24-hour urine collection, to test kidney function and collect material for genetic testing. * Donor participants will also have a magnetic resonance imaging (MRI) scan of their remaining kidney.
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae), L2 and below. The primary endpoint will be the assessment of fusion by evaluation of x-rays taken following surgery at each visit. The x-ray evaluation will be conducted by a radiologist who is blinded to the type of treatment each patient has received. Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative (post-op). Questionnaires and x-rays will be completed at each visit and a computed tomography (CT) scan will be taken at the 12 month visit(and used to aid in assessment of bridging bone, where appropriate).
This study is designed to collect longitudinal biological samples from patients after hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers to validate biomarkers of both acute and chronic GVHD as well as for use in future unspecified research. The centers include Dana-Farber Cancer Institute and Boston's Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and Indiana University Simon Cancer Center.