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Hematopoietic Cell Transplantation

Kidney + Marrow Cell Transplant for Immune Tolerance

Q: Are Combined Deceased Donor Kidney and Hematopoietic Cell Transplants a considerable hazard to human health?

Due to the limited data regarding efficacy and safety, Combined Deceased Donor Kidney and Hematopoietic Cell Transplants was rated a 1 on our team's scale.

Q: Does this research have an age restriction, and if so, what is it?

Appropriate applicants for this investigation must be within the limits of adolescence and elderliness, that is between 18 to 65 years old.

Q: Are there any opportunities available to enroll in this clinical experiment?

Data hosted on clinicaltrials.gov indicates that presently, this medical trial is not recruiting any participants; the listing was posted and last updated on May 6th 2022. However, there are five other studies currently enrolling patients at this time.

Q: Is there an opportunity to be involved in this research?

To qualify for this clinical trial, individuals must have immune tolerance and be within the age bracket of 18 to 65 years old. The study is currently accepting roughly 30 participants.

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3,6,9,12,15,18,24,48,60 months for reporting.

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 more

Trial 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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,341,206 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

Combined Deceased Donor Kidney and Hematopoietic Cell Transplants (Hematopoietic Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT04571203 — Phase 1

Immune Tolerance Research Study Groups: Phase I Study of Combined DD Kidney and HCT Transplant

Immune Tolerance Clinical Trial 2023: Combined Deceased Donor Kidney and Hematopoietic Cell Transplants Highlights & Side Effects. Trial Name: NCT04571203 — Phase 1

Combined Deceased Donor Kidney and Hematopoietic Cell Transplants (Hematopoietic Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04571203 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are Combined Deceased Donor Kidney and Hematopoietic Cell Transplants a considerable hazard to human health?

"Due to the limited data regarding efficacy and safety, Combined Deceased Donor Kidney and Hematopoietic Cell Transplants was rated a 1 on our team's scale."

Answered by AI

Does this research have an age restriction, and if so, what is it?

"Appropriate applicants for this investigation must be within the limits of adolescence and elderliness, that is between 18 to 65 years old."

Answered by AI

Are there any opportunities available to enroll in this clinical experiment?

"Data hosted on clinicaltrials.gov indicates that presently, this medical trial is not recruiting any participants; the listing was posted and last updated on May 6th 2022. However, there are five other studies currently enrolling patients at this time."

Answered by AI

Is there an opportunity to be involved in this research?

"To qualify for this clinical trial, individuals must have immune tolerance and be within the age bracket of 18 to 65 years old. The study is currently accepting roughly 30 participants."

Answered by AI

Recent research and studies

Science Translational MedicineJournal

Mixed Chimerism and Acceptance of Kidney Transplants After Immunosuppressive Drug Withdrawal

Busque, Stephan, John D. Scandling, Robert Lowsky, Judith Shizuru, Kent Jensen, Jeffrey Waters, Hsin-Hsu Wu, et al.. 2020. “Mixed Chimerism and Acceptance of Kidney Transplants After Immunosuppressive Drug Withdrawal”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.aax8863.

clinicaltrials.govStudy

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

Stephan Busque 2022. "Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04571203.