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Hematopoietic Cell Transplantation
Kidney + Marrow Cell Transplant for Immune Tolerance
Phase 1
Waitlist Available
Led By Robert Lowsky, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Projected cold ischemia time <24 hours.
Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3,6,9,12,15,18,24,48,60 months
Awards & highlights
Study Summary
This trial is testing if it's safe and effective to give marrow cells from a deceased donor to people getting a kidney transplant.
Who is the study for?
Adults aged 18-65 with End Stage Renal Disease who haven't had a kidney transplant yet, match the donor in at least one HLA locus, and can sign informed consent. They must agree to use contraception for a year post-transplant and have no allergies to rabbit protein or history of certain diseases. Donors should be brain-dead individuals aged 16-55 without certain infections or malignancies.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of combining kidney transplants from deceased donors with vertebral body marrow cell infusions. It's a phase 1 trial where all participants receive the same treatment to see how well it works and what doses are safe.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune suppression such as increased risk of infection, possible adverse reaction to rabbit ATG (a medication used in transplantation), or complications from low dose irradiation used during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tissue sample will be kept cold for less than 24 hours before use.
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I have severe kidney failure and am a candidate for my first kidney transplant.
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The donor of the organ was between 16 and 55 years old and declared brain dead.
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I am on the transplant waiting list for an organ from a deceased donor.
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I am not allergic or unable to tolerate rabbit ATG or low dose irradiation.
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I have permission from the OPO for vertebral body donation.
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I have at least one matching HLA marker with my donor.
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I am not pregnant.
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I am between 18 and 64 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3,6,9,12,15,18,24,48,60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3,6,9,12,15,18,24,48,60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the dose of TBI that will support donor CD3 Tcell chimerism between 30-75% at 45 days post infusion
Number of patients out of the total patients enrolled who received both the kidney and the bone marrow from the same donor.
Secondary outcome measures
Donor-Specific Antibody (DSA)
Number of patients who develop GVHD, all grades and types, within 60 months of kidney transplant
Number of patients with either bacterial, viral or fungal infection within 12 months post transplant .
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Phase I Study of Combined DD Kidney and HCT TransplantExperimental Treatment1 Intervention
Single arm Phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,408 Previous Clinical Trials
17,343,422 Total Patients Enrolled
1 Trials studying Immune Tolerance
15 Patients Enrolled for Immune Tolerance
Robert Lowsky, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
42 Total Patients Enrolled
Samuel Strober, MDStudy ChairStanford University
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Immune Tolerance
15 Patients Enrolled for Immune Tolerance
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tissue sample will be kept cold for less than 24 hours before use.I have severe kidney failure and am a candidate for my first kidney transplant.The donor of the organ was between 16 and 55 years old and declared brain dead.I am on the transplant waiting list for an organ from a deceased donor.I have smoked more than 5 pack-years, smoked within the last 10 years, or have a close relative with lung cancer.I weigh more than 90kg or my BMI is over 35.I have had cancer before, but not skin cancer.I have had an organ transplant.My kidney donor's profile index is above 70%.I have a history of autoimmune disease.I am not allergic or unable to tolerate rabbit ATG or low dose irradiation.I am not currently on medication for any bacterial, viral, or fungal infection.My kidney disease is at high risk of returning after a transplant.I have positive donor-specific antibodies.I have an infection that affects my whole body.I have been diagnosed with Zika virus in the last 6 months.I have permission from the OPO for vertebral body donation.My donor has EBV antibodies but I do not.I agree to use reliable birth control for at least 1 year after my transplant.I have at least one matching HLA marker with my donor.I am not pregnant.I am between 18 and 64 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Study of Combined DD Kidney and HCT Transplant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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