This is a study for hypersensitized patients who have been waiting for more than 3 years for an offer for a kidney transplant. The objective is to perform a transplant of autologous hematopoietic precursors with the aim of producing what we call an immunological reset to make the maximum number of anti-HLA antibodies disappear and thus increase the chances of the patient receiving an offer for a kidney transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
An apheresis is performed on the patients and a selection of CD34 hematopoietic progenitors is performed. Subsequently, conditioning is performed with cyclophosphamide, thymoglobulin, corticosteroids and rituximab to subsequently infuse the hematopoietic precursors.
Hospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGTo evaluate the impact of autologous hematopoietic stem cell transplantation (aHSCT)
Variable composed with the proportion of patients in whom ≥10 HLA, class I or class II antibodies are eliminated (undetectable or \<1000 MFI) or the percentage of baseline cPRA is decreased at 6 months after aHSCT, in the absence of severe undesirable effects related to the treatment.
Time frame: from enrolment to 12 months post-TPHa
Proportion of patients achieving all of the following items at 6 months post-aHSCT or at the time of kidney transplant, if a compatible offer is received
Proportion of patients achieving all of the following items at 6 months post-aHSCT or at the time of kidney transplant, if a compatible offer is received * Elimination/reduction of HLA antibody-secreting plasma cells in the bone marrow * Absence/reduction of HLA-specific memory B cells in circulation
Time frame: from enrolment to 12 months post-aHSCT
Total number of HLA antibodies eliminated
Total number of HLA antibodies eliminated
Time frame: from enrolment to 6 months post-aHSCT
Average number of HLA antibodies eliminated
Average number of HLA antibodies eliminated
Time frame: from enrolment to 6 months post-aHSCT
Mean reduction in MFI of immunodominant HLA antibody, class I and class II
Mean reduction in MFI of immunodominant HLA antibody, class I and class II
Time frame: from enrolment to 6 months post-aHSCT
Proportion of patients transplanted with a compatible donor
Proportion of patients transplanted with a compatible donor
Time frame: from enrolment to 12 months post-aHSCT
Adverse reactions related to aHSCT
Mesure the number of adverse reactions related to aHSCT
Time frame: from enrolment to 12 months post-aHSCT
Incidence of opportunistic infections
Mesure the Incidence of opportunistic infections in treated patients
Time frame: From aHSCT to 12 months after aHSCT or 12 months after kidney transplant (if it's occurs)
Incidence of clinical and/or subclinical rejection mediated by antibodies in the first year after kidney transplantation
Incidence of clinical and/or subclinical rejection mediated by antibodies in the first year after kidney transplantation
Time frame: from kidney trasplantation to 12 months after
Proportion of patients free of DSA and/or donor-specific memory B cells at 1 year after kidney transplant
Proportion of patients free of DSA and/or donor-specific memory B cells at 1 year after kidney transplant
Time frame: from kidney transplant to 1 year post kidney transplant
Changes in the clonal and phenotypic repertoire of B and T cells.
Changes in the clonal and phenotypic repertoire of B and T cells mesure with cytometry
Time frame: From aHSCT to 12 months after aHSCT or 12 months after kidney transplant (if it's occurs)
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