ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNorthwestern University
About this trial
This is a phase 1 trial, 36 month duration for subjects with end-stage renal disease (ESRD). The objectives of the trail are1) Determine the safety of ECP-DL cell infusion in living donor renal transplant recipients. 2) Determine rates of graft rejection and compare to historical controls.
One week prior to planned LDK transplant the donor and recipient pair will be seen for ECP-DL preparation and infusion. Donors will undergo one single unstimulated peripheral blood mononuclear cell collection using the THERAKOS® CELLEX® Photopheresis System; the cell product will then undergo ECP treatment to make ECP-DL, which will then be infused into the recipient. One week later, recipients (n=12) will undergo LDK transplant using standard of care maintenance immunosuppression without antibody induction therapy. Subsequent patients will receive cell infusions in escalating cell doses. A minimum of two months will be used as an interval between ECP-DL treatment in each tier. A staggered approach for moving to the next tier will be employed waiting no less than two months to ensure absence of adverse events using the following tier dosing schema:
Tier 1: 0.5 x 10\^9 ECP-DL treated cells (n=4) Tier 2: 1 x 10\^9 ECP-DL treated cells (n=4) Tier 3: 2 x 10\^9 ECP-DL treated cells (n=4)
Following transplant, LDK recipients will undergo ECP using the Therakos system on two consecutive days per month for 6 months (12 treatments). Peripheral IV access will be used whenever possible.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Recipient age ≥30 and less than 70 years old.
Donor age ≥18 and ≤ 70 years old.
Recipient of a first kidney transplant from a living unrelated or living related donor that is not HLA-identical to the donor.
Donor willing to undergo cell collection for ECP-DL cell preparation and infusion.
Disqualifiers
Known sensitivity or contraindication to everolimus, tacrolimus, or psoralen.
Aphakia.
Has undergone splenectomy
Patients with light-sensitive diseases including (but not limited to) systemic lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porhyria, xeroderma pigmentosum, and albinism
Trial design
Design model
Sequential
Treatments tested in this trial
ECP-DL treated mononuclear cell infusion
DeviceParticipants in this study will undergo the infusion of donor white blood cells treated with ECP one week before their living donor kidney transplant, combined with standard of care antirejection medications. You will also then have ECP treatments using your own blood on two consecutive days once per month for 6 months. This combination is intended to cause your immune system to create a state called tolerance to the donor kidney. The ECP procedure has not been approved to prevent rejection after kidney transplant and the use of ECP to prevent rejection of transplanted organs is experimental, and is not a part of standard treatment which is based on the long term use of anti-rejection drugs such as tacrolimus (Prograf), everolimus, and prednisone.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: ECP-DL Cell Therapy ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events Following Escalating Doses of ECP-DL Cells
To determine the safety profile of escalating doses of ECP-DL cells administered to patients undergoing living donor kidney transplantation.
Time frame
From Day -7 (first ECP-DL infusion) through 24 months post transplantSecondary outcomes
1
Incidence of Transplant-Related Adverse Events
To assess the frequency and type of adverse events associated with renal transplantation and immunosuppressive therapy.
Time frame
Baseline through 24 months post-transplant.2
Incidence and Severity of Infections
To evaluate the incidence, timing, and severity of bacterial, viral, and fungal infections post-transplant.
Time frame
Baseline through 24 months post-transplant3
Changes in Peripheral Blood Lymphocyte Subpopulations
To assess changes in lymphocyte subpopulations, including regulatory T cells and effector T cells, following ECP-DL infusion.
Time frame
Baseline, Day 0, Day 7, Day 30, and Month 64
Change in Donor-Specific T Cell Response as Measured by Mixed Lymphocyte Reaction (MLR) and ELISPOT Assays
Donor-specific hyporesponsiveness will be assessed by measuring the proliferation of recipient peripheral blood mononuclear cells (PBMCs) in response to donor antigens using Mixed Lymphocyte Reaction (MLR), and by quantifying interferon-gamma (IFN-γ) producing cells using ELISPOT assays. Results will be reported as stimulation index (SI) for MLR and spot-forming units (SFU) per 10\^6 PBMCs for ELISPOT.
Time frame
Baseline, Day 30, and Month 6Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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