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Primary Graft Failure clinical trials

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NCT ID: NCT04105803 Enrolling by invitation - Clinical trials for Cardiac Allograft Vasculopathy

Cardiac Mitochondrial Function After Heart Transplantation

ENERGY-HTX
Start date: April 25, 2019
Phase:
Study type: Observational

Studies have shown that cardiac function is affected immediately after heart transplantation (HTx), but seems to recover to some extent over the first year. This immediate effect is associated with lack of oxygen in the tissue and reperfusion injury causing cellular energy depletion, mitochondrial failure and cellular damage. This condition may progress into full blown primary graft failure (PGF), characterized as deterioration of the transplanted heart, which is seen in 3-30 % of HTx patients. In addition to PGF, chronic rejection owing to cardiac allograft vasculopathy (CAV) may develop. PGF and CAV remain the major heart related mortality causes, and additional assessment and treatments are therefore needed. Acute cellular rejection (ACR) is diagnosed based on endomyocardial biopsies (EMB), which are routinely performed to ensure prober immunosuppression in HTx patients. ACR occur in approximately 25% of HTx patients, and is associated with PGF and CAV. However, mitochondrial function and integrity may prove to be a more sensitive marker of allograft rejection than endomyocardial biopsies. Therefore, assessment of mitochondrial function may allow for earlier detection of allograft rejection and dysfunction. This may be of particular importance as emerging treatments are targeting both energy substrate supply for adenosine-triphosphate generation produced by the mitochondria and mitochondrial function in the failing heart. Despite the association between graft rejection and mitochondrial function, it remains unsettled whether mitochondrial function associate with PGF, ACR and CAV. Such findings may be of prognostic importance and even elucidate new treatment targets. Hence, we evaluate the mitochondrial status in HTx patients through four studies designed to assess different aspects of the interplay between cardiac function and mitochondrial integrity and function. Hypotheses: Study 1: Primary graft pump function is correlated to mitochondrial function in the first myocardial biopsy taken from the donor heart during the operation. Study 2: Cardiac mitochondrial function improves over the first 3 months after a heart transplantation. Study 3: Heart transplant patients with moderate to severe coronary graft vasculopathy has impaired mitochondrial function. Study 4: Myocardial external energy efficiency by positron-emission tomography can be used as a marker of mitochondrial function and chronic rejection in HTx patients.

NCT ID: NCT03541889 Recruiting - Clinical trials for Primary Graft Failure

REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

REVEAL
Start date: February 5, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find new tests that could help determine if the newly infused bone marrow cells are growing well after bone marrow transplantation or if new bone marrow cells are needed. In this study we will use FLT imaging which is an investigational imaging test, and collect blood samples to investigate if the cells are growing well.

NCT ID: NCT02161783 Recruiting - Clinical trials for Primary Graft Failure

Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

Start date: October 6, 2014
Phase:
Study type: Observational

This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure. The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.