← Back to Search

Blood Stem Cell Transplant

Donor Stem Cell Infusion for Kidney Transplant Rejection (CIRM Trial)

Q: Is there an opportunity for me to partake in this trial?

Eligible candidates should possess immunological tolerance and fall within the 18-65 age bracket. This research project is aiming to recruit approximately 24 individuals.

Q: Can adults who have reached the age of majority participate in this trial?

This trial requires participants to be between 18 and 65 years old, as indicated by the inclusion criteria.

Q: Are there any open spots for participants in this medical experiment?

According to the details provided on clinicaltrials.gov, this current medical experiment is actively searching for test subjects. This trial was initially announced in February of 2017 and received its last update in July 2020.

Q: How many research participants are enrolled in this investigation?

Affirmative, the data found on clinicaltrials.gov indicates that enrollment for this medical trial is ongoing. This study was initially posted February 14th 2017 and underwent its most recent update July 15th 2020. Two sites are actively working to recruit a total of 24 patients.

Phase < 1

Waitlist Available

Research Sponsored by Samuel Strober

Eligibility Criteria Checklist

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

Must have

All consenting adults (18 years of age) living donor renal transplant recipients at Stanford University Medical Center who have a one haplotype match donor

Patients who have no known contraindication to administration of rabbit ATG or radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post-transplant

Awards & highlights

CIRM Trial Summary

This trial will study if donor blood stem cells can help prevent kidney rejection after transplant.

Who is the study for?

This trial is for adults over 18 who need a kidney transplant and have a related donor with at least one matching HLA haplotype, or an unrelated donor matching at least two HLA antigens. Participants must not be allergic to rabbit proteins, have certain infections (HIV, Hepatitis B/C), or high-risk primary kidney disease recurrence.Check my eligibility

What is being tested?

The study tests if introducing donor blood stem cells after kidney transplantation can adjust the immune system so that patients might reduce or stop taking immunosuppressive drugs without rejecting the new kidney.See study design

What are the potential side effects?

Potential side effects may include reactions to rabbit ATG (a drug used in transplants) such as fever and chills, risk of infection due to immune suppression changes, and possible complications from low white blood cell or platelet counts.

CIRM Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am an adult kidney transplant recipient at Stanford with a partially matched donor.

Select...

I am not allergic to rabbit ATG or radiation treatments.

CIRM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-transplant for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Reduction of dependence on immunosuppressive drugs to prevent graft rejection.

Secondary outcome measures

Incidence of graft loss.

Incidence of rejection episodes requiring corticosteroid therapy

CIRM Trial Design

1Treatment groups

Experimental Treatment

Group I: Immune tolerance after kidney transplantExperimental Treatment2 Interventions

Immune tolerance after kidney transplant will be induced by transfusion of enriched donor blood stem cells and T cells to initiate blood cell mixed chimerism in patients conditioned with total lymphoid irradiation and rabbit anti-thymocyte globulin after kidney transplant. Patients will receive corticosteroids for 14 weeks with gradual dose reduction. They will also receive 12 months of mycophenolate mofetil and 18 months of tacrolimus with dose tapering beginning 9 months post-transplant and continuing as long as mixed chimerism is maintained and there is no evidence of graft versus host disease and no kidney rejection evident. Patients losing chimerism will continue on low dose immunosuppressive drug doses unless additional kidney rejection therapy is needed.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Samuel StroberLead Sponsor

California Institute for Regenerative Medicine (CIRM)OTHER

63 Previous Clinical Trials

3,124 Total Patients Enrolled

Samuel Md Strober, MDStudy ChairStanford University

1 Previous Clinical Trials

25 Total Patients Enrolled

1 Trials studying Immune Tolerance

25 Patients Enrolled for Immune Tolerance

Media Library

Donor blood stem cells and T cells (Blood Stem Cell Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT03292445 — Phase < 1

Immune Tolerance Research Study Groups: Immune tolerance after kidney transplant

Immune Tolerance Clinical Trial 2023: Donor blood stem cells and T cells Highlights & Side Effects. Trial Name: NCT03292445 — Phase < 1

Donor blood stem cells and T cells (Blood Stem Cell Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03292445 — Phase < 1

Frequently Asked Questions

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

Is there an opportunity for me to partake in this trial?

"Eligible candidates should possess immunological tolerance and fall within the 18-65 age bracket. This research project is aiming to recruit approximately 24 individuals."

Answered by AI

Can adults who have reached the age of majority participate in this trial?

"This trial requires participants to be between 18 and 65 years old, as indicated by the inclusion criteria."

Answered by AI

Are there any open spots for participants in this medical experiment?

"According to the details provided on clinicaltrials.gov, this current medical experiment is actively searching for test subjects. This trial was initially announced in February of 2017 and received its last update in July 2020."

Answered by AI

How many research participants are enrolled in this investigation?

"Affirmative, the data found on clinicaltrials.gov indicates that enrollment for this medical trial is ongoing. This study was initially posted February 14th 2017 and underwent its most recent update July 15th 2020. Two sites are actively working to recruit a total of 24 patients."

Answered by AI