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Hematopoietic Stem Cell Transplantation

Stem Cell + Treg Therapy for Kidney Transplant

Phase 1

Recruiting

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant

All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial will test whether a combination of radiation and drugs followed by infusion of donor cells will allow recipients to eventually stop taking anti-rejection drugs after receiving a kidney from a living donor.

Who is the study for?

Adults aged 18-65 who need a kidney transplant and have a related or unrelated living donor with at least one matching HLA marker can join. They must be able to take rabbit ATG, radiation, and agree to use reliable contraception for a year post-transplant. Those with high recurrence risk of kidney disease, previous rabbit ATG treatment or allergy, certain cancers, HIV/Hepatitis B/C infection, low blood counts, prior transplants, severe heart disease or high antibody levels against the donor cannot participate.Check my eligibility

What is being tested?

The study is testing if using total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) along with an infusion of the donor's stem cells and recipient Tregs can help patients stop taking anti-rejection drugs after getting a new kidney from a living donor.See study design

What are the potential side effects?

Possible side effects include reactions to rabbit proteins in ATG like fever and chills; risks associated with radiation such as fatigue and nausea; immune system suppression leading to increased infection risk; potential infertility due to radiation; and complications from stem cell infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use reliable birth control for at least 1 year after my transplant.

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I am between 18 and 65 years old and am receiving a kidney transplant from a matched donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Count of participants able to withdraw from immunosuppressive drugs without evidence of rejection at 18 months

Count of participants with sustained mixed chimerism of >25% at 18 months

Secondary outcome measures

Count of participants with adverse events associated with the infusion of the Tregs cell product

Count of participants with bacterial, viral, or fungal infections

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combined kidney/stem cell transplants and recipient's TregsExperimental Treatment1 Intervention

Preparatory regimen including TLI, TBI, ATG after kidney transplantation followed by infusion of donor CD34+, T cell and recipient Tregs

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,328 Total Patients Enrolled

California Institute for Regenerative Medicine (CIRM)OTHER

64 Previous Clinical Trials

3,135 Total Patients Enrolled

Northwestern UniversityOTHER

1,589 Previous Clinical Trials

917,104 Total Patients Enrolled

Media Library

Infusion of Donor Hematopoetic Stem Cells (Hematopoietic Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03943238 — Phase 1

Kidney Transplant Research Study Groups: Combined kidney/stem cell transplants and recipient's Tregs

Kidney Transplant Clinical Trial 2023: Infusion of Donor Hematopoetic Stem Cells Highlights & Side Effects. Trial Name: NCT03943238 — Phase 1

Infusion of Donor Hematopoetic Stem Cells (Hematopoietic Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03943238 — Phase 1

Frequently Asked Questions

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

Does the FDA recognize Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs as a legitimate treatment option?

"Our internal research has concluded that the safety of Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs can be considered low, having been rated a 1 on our scale. This is due to it being an early stage investigation with limited evidence supporting its efficacy or safety."

Answered by AI

Is this research open to participants that are of legal age?

"This trial seeks patients who are of legal age and under the retirement threshold."

Answered by AI

Is my profile suitable for taking part in this experiment?

"For this clinical trial, 22 patients with kidneys aged 18-65 are necessary. Essential qualifications to participate include being a consenting adult between the specified age parameters and having undergone living donor renal transplant at either Stanford University Medical Center or Northwestern Medicine with a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match)."

Answered by AI

Are volunteers able to join this research venture at present?

"Per the records on clinicaltrials.gov, this research study is currently in search of participants. The trial was originally posted on February 1st 2020 and most recently changed on May 6th 2022."

Answered by AI

How many participants have enrolled in this investigation?

"Affirmative. The clinical trial's record on clinicaltrials.gov reveals that, since its launch on February 1st 2020 and most recent edit in May 6th 2022, this research has been recruiting participants from two centres for a total of 22 individuals."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Induced Immune Tolerance for Kidney Transplantation

Scandling, John D., Stephan Busque, Judith A. Shizuru, Edgar G. Engleman, and Samuel Strober. 2011. “Induced Immune Tolerance for Kidney Transplantation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmc1107841.

American Journal of TransplantationJournal

Chimerism, Graft Survival, and Withdrawal of Immunosuppressive Drugs in HLA Matched and Mismatched Patients After Living Donor Kidney and Hematopoietic Cell Transplantation

Scandling, J. D., S. Busque, J. A. Shizuru, R. Lowsky, R. Hoppe, S. Dejbakhsh-Jones, K. Jensen, et al.. 2015. “Chimerism, Graft Survival, and Withdrawal of Immunosuppressive Drugs in HLA Matched and Mismatched Patients After Living Donor Kidney and Hematopoietic Cell Transplantation”. American Journal of Transplantation. Wiley. doi:10.1111/ajt.13091.

Human ImmunologyJournal

Tolerance Induction in HLA Disparate Living Donor Kidney Transplantation by Facilitating Cell-enriched Donor Stem Cell Infusion: The Importance of Durable Chimerism

Leventhal, Joseph R., and Suzanne T. Ildstad. 2018. “Tolerance Induction in HLA Disparate Living Donor Kidney Transplantation by Facilitating Cell-enriched Donor Stem Cell Infusion: The Importance of Durable Chimerism”. Human Immunology. Elsevier BV. doi:10.1016/j.humimm.2018.01.007.

ChimerismJournal