Health TrialsbyHealthPanel

Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment

ConditionImmune Tolerance
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University

About this trial

This is a single arm phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is ≥ 18 years old, and <65 years of age.

Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care.

Listed with the Organ Procurement and Transplantation Network (OPTN) for deceased donor transplantation.

A serotypic (Human Leucocyte Antigen) HLA match with the donor of a least 1 locus in A, B or DR.

Disqualifiers

Known allergy to rabbit protein.

History of malignancy with the exception of non melanoma skin malignancy.

Pregnant woman or nursing mother.

Body weight >90kg or BMI >35.

Trial design

Design model

Single group

Treatments tested in this trial

  • Combined Deceased Donor Kidney and Hematopoietic Cell Transplants

    Biological/Vaccine

    This combined kidney and hematopoietic cell transplants with a conditioning regimen with irradiation and ATG creates an environment of immune-tolerance. This promotes hematopoietic cell engraftment.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Phase I Study of Combined DD Kidney and HCT TransplantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients out of the total patients enrolled who received both the kidney and the bone marrow from the same donor.

Time frame
6 months
2

Determine the dose of TBI that will support donor CD3 Tcell chimerism between 30-75% at 45 days post infusion

TBI dose in cGy associated with donor Tcell chimerism of \>30 % immunosuppressive drug monotherapy.

Time frame
day 45

Secondary outcomes

1

Number of patients who develop GVHD, all grades and types, within 60 months of kidney transplant

Time frame
60 months
2

Number of patients with either bacterial, viral or fungal infection within 12 months post transplant .

Time frame
12 months
3

Serum Creatinine

Time frame
up to 60 months
4

Panel-Reactive Antibody (PRA)

Report % of PRA on all participants

Time frame
Baseline, month 9, and month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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