مركز الزراعة

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. A Study of Patients Treated for Chronic Granulomatous Disease Since 1995

   Rochester, Minn.

   Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone marrow transplantation has been shown to be curative. However the risks of transplantation are high and not all patients with CGD may need to undergo this high risk procedure. The purpose of this study is to determine the long term medical condition and daily functioning of patients with CGD after a transplant and if possible, compare these results to patients who do not undergo a transplant.

2. Concomitant Renal and Urinary Bladder Allograft Transplantation

   Rochester, Minn.

   Patients that need reconstruction or re-building of their urinary bladder are often limited to having a segment of their intestine used for that purpose. Using intestine is less than ideal as it is an absorptive, mucous producing tissue and placing this in constant contact with urine creates significant long term problems. In patients that require a kidney transplant and bladder reconstruction, this study seeks to use a bladder graft from a deceased donor rather than intestine.

3. Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas

   Rochester, Minn.

   To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.

4. A Study to Assess Feasibility and Benefit of a Patient-reported Outcomes Quality of Life Tool for Hematology and Medical Oncology

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine the feasibility and benefit of a patient-reported outcomes quality of life tool for hematology and medical oncology.

5. BT – L-CsA – 301 – SLT: A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Syndrome / Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation

   Jacksonville, Fla.

   The purpose of this study is to analyze L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following single-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.

6. A Study to Develop a Breath Analysis Test

   Jacksonville, Fla.

   The purposes of this study are to establish breath sample collection and analysis techniques, to establish reference ranges for selected clinical populations, and to assess correlations between breath analysis and presence or absence of clinical or pathological evidence of disease.

7. A Study to Assess the Updated Prospera™ Diagnostic Test

   Scottsdale/Phoenix, Ariz.

   The purpose of this study to collect blood samples and data to assess the diagnostic capability of an updated version of the Prospera™ test.  The current standard of care for detection of rejection in renal allograft recipients is serum creatinine, often used in combination with other blood tests such as proteinuria. Natera has developed an assay called Prospera™ to detect the amount of donor-derived cell-free DNA (dd-cfDNA), which is a marker of kidney rejection.

8. A Study of Study of Immune Tolerance Mechanisms in Kidney Transplant Patients

   Scottsdale/Phoenix, Ariz.

   Hypothesis: we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, including DSA-mediated kidney transplant rejection. In addition, oral corticosteroid treatment significantly alters the frequency and function of Breg subsets, which could lead altered clinical outcomes.
   
   Aims, purpose, or objectives:
   1. Investigate the frequency Bregs and their ability to express IL-10 along with other immune cells in the context of tolerance/rejection in kidney transplant patients.
   we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, including DSA-mediated kidney transplant rejection.
   
   2.Investigate the frequency and functions of Bregs along with other immune cells in the setting of long term corticosteroid use.
   We hypothesize that oral corticosteroid treatment significantly alters the frequency and function of Breg subsets, which could lead altered clinical outcomes.

9. An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed participation to BOSTON-1 and BOSTON-2 studies

   Jacksonville, Fla.

   The purpose of this study is to assess the long-term effectiveness and safety of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

   Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.

10. A Study to Evaluate Alloantibody Titer in Highly Sensitized Kidney Transplant Candidates

    Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate the utility of using anti-HLA antibody titer to measure the effectiveness of antibody lowering therapy (i.e., desensitization) in highly-sensitized kidney transplant candidates.

     

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. A Study of Patients Treated for Chronic Granulomatous Disease Since 1995

   Rochester, Minn.

   Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone marrow transplantation has been shown to be curative. However the risks of transplantation are high and not all patients with CGD may need to undergo this high risk procedure. The purpose of this study is to determine the long term medical condition and daily functioning of patients with CGD after a transplant and if possible, compare these results to patients who do not undergo a transplant.

2. Concomitant Renal and Urinary Bladder Allograft Transplantation

   Rochester, Minn.

   Patients that need reconstruction or re-building of their urinary bladder are often limited to having a segment of their intestine used for that purpose. Using intestine is less than ideal as it is an absorptive, mucous producing tissue and placing this in constant contact with urine creates significant long term problems. In patients that require a kidney transplant and bladder reconstruction, this study seeks to use a bladder graft from a deceased donor rather than intestine.

3. Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas

   Rochester, Minn.

   To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.

4. A Study to Assess Feasibility and Benefit of a Patient-reported Outcomes Quality of Life Tool for Hematology and Medical Oncology

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine the feasibility and benefit of a patient-reported outcomes quality of life tool for hematology and medical oncology.

5. BT – L-CsA – 301 – SLT: A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Syndrome / Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation

   Jacksonville, Fla.

   The purpose of this study is to analyze L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following single-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.

6. A Study to Develop a Breath Analysis Test

   Jacksonville, Fla.

   The purposes of this study are to establish breath sample collection and analysis techniques, to establish reference ranges for selected clinical populations, and to assess correlations between breath analysis and presence or absence of clinical or pathological evidence of disease.

7. A Study of Study of Immune Tolerance Mechanisms in Kidney Transplant Patients

   Scottsdale/Phoenix, Ariz.

   Hypothesis: we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, including DSA-mediated kidney transplant rejection. In addition, oral corticosteroid treatment significantly alters the frequency and function of Breg subsets, which could lead altered clinical outcomes.
   
   Aims, purpose, or objectives:
   1. Investigate the frequency Bregs and their ability to express IL-10 along with other immune cells in the context of tolerance/rejection in kidney transplant patients.
   we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, including DSA-mediated kidney transplant rejection.
   
   2.Investigate the frequency and functions of Bregs along with other immune cells in the setting of long term corticosteroid use.
   We hypothesize that oral corticosteroid treatment significantly alters the frequency and function of Breg subsets, which could lead altered clinical outcomes.

8. A Study to Assess the Updated Prospera™ Diagnostic Test

   Scottsdale/Phoenix, Ariz.

   The purpose of this study to collect blood samples and data to assess the diagnostic capability of an updated version of the Prospera™ test.  The current standard of care for detection of rejection in renal allograft recipients is serum creatinine, often used in combination with other blood tests such as proteinuria. Natera has developed an assay called Prospera™ to detect the amount of donor-derived cell-free DNA (dd-cfDNA), which is a marker of kidney rejection.

9. An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed participation to BOSTON-1 and BOSTON-2 studies

   Jacksonville, Fla.

   The purpose of this study is to assess the long-term effectiveness and safety of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

   Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.

10. A Study to Evaluate Alloantibody Titer in Highly Sensitized Kidney Transplant Candidates

    Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate the utility of using anti-HLA antibody titer to measure the effectiveness of antibody lowering therapy (i.e., desensitization) in highly-sensitized kidney transplant candidates.