Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)

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Вход / Регистрация

Линкът е запазен в клипборда

СъстояниеПрекратено

Спонсори

University Medical Centre Ljubljana

Сътрудници

Slovenian Research Agency

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT03585855

BioSeek: nct03585855

Ключови думи

Резюме

Transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. With the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory, as most of the renal transplants develop chronic graft rejection. Unfortunately, there is little the investigators know when it comes to improving long-term survival of renal transplants. Mesenchymal stem cells (MSC) have been shown to have immunosuppressive and repairing properties. The purpose of this study is to find out whether MSC in combination with standard therapy of antibody mediated rejection (ABMR) are more effective in preventing organ deterioration and maintaining kidney function.

Описание

Participants will be assigned to receive the full immunosuppressive therapy indicated to treat chronic ABMR (including plasmapheresis (PF) 7x, intravenous immune globulins 100 mg/kg 7x, corticosteroid) and MSC infusions (2x106cells/kg bw after PF) (Group 1) and be compared to historic controls according to "propensity score matching" (treated with immunosuppressive therapy alone (Group 2)). Patients will undergo MSC infusions at the start of the study after each PF. One year post- infusions, patients will be evaluated and undergo kidney biopsies. Blood collection will occur at regular intervals, serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function and morphology (US Doppler) will be evaluated.

Дати

Последна проверка:	06/30/2019
Първо изпратено:	06/24/2018
Очаквано записване подадено:	07/08/2018
Първо публикувано:	07/12/2018
Изпратена последна актуализация:	07/23/2019
Последна актуализация публикувана:	07/24/2019
Действителна начална дата на проучването:	12/31/2018
Приблизителна дата на първично завършване:	07/22/2019
Очаквана дата на завършване на проучването:	07/22/2019

Състояние или заболяване

Interventional

Интервенция / лечение

Other: MSC transplantation

Фаза

Групи за ръце

Arm	Интервенция / лечение
No Intervention: Historic control historic cohort of patients with ABMR treated with standard of care therapy
Experimental: MSC transplantation patients with ABMR treated with MSC transplantation	Other: MSC transplantation MSC transplantation: patients with ABMR treated with MSC transplantation

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	18 Years Да се 18 Years
Полове, допустими за проучване	All
Приема здрави доброволци	Да
Критерии	Inclusion Criteria: - Recipients of a renal allograft, male and female patients age >18 - The eGF>20 ml/min/1.73 m2, - Renal biopsy Criteria: chronic active ABMR. - Written informed consent, compliant with local regulations. Exclusion Criteria: - Recipients of multiple organs. - Pregnant women. - Malignant disease in last 5 years - Active autoimmune disease - Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis - Evidence of congestive cardiac failure and/or acute coronary syndrome in past 6 months. - Evidence of liver disease - Inadequate compliance to treatment.

Резултат

Първични изходни мерки

1. Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR) [12 months]

Adverse events according to CTCAE Version 5

Вторични изходни мерки

1. Estimated glomerular filtration rate (eGFR) [12 months]

eGFR at up to 12 months post MSC transplantation

2. Graft survival rate [12 months]

Graft survival rate at 12 months post MSC transplantation