RecruitingPhase 1

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

United States30 participantsStarted 2022-05-06

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year post transplant.
. Females have a negative serum pregnancy test.
. Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.
. No known contraindication to administration of rabbit ATG or low dose irradiation.

Exclusion criteria

. Known allergy to rabbit protein.
. History of malignancy with the exception of non melanoma skin malignancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months

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

Timeframe: day 45

Trial details

NCT IDNCT04571203

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-01

Contact for this trial

Carlos Lazarte, B.A.

6505548610 lazarte6@stanford.edu

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