Your session is about to expire
← Back to Search
Stem Cell Therapy
Stem Cell Infusion for Kidney Transplant Tolerance
Phase 1
Recruiting
Led By Jeffrey Veale, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether patients with a kidney transplant from a HLA-identical living donor can stop taking immunosuppressive drugs without damaging the transplanted kidney, by receiving hematopoietic stem cells from the same donor.
Who is the study for?
Adults over 18 with a well-functioning kidney transplant from an HLA-identical living donor can join. They must have good physical function, heart and liver health, no major post-transplant complications or rejection history, and stable kidney function. Women of childbearing age must use contraception.
What is being tested?
The trial tests if patients can stop taking anti-rejection drugs after receiving stem cells from their kidney donor. It includes a conditioning regimen with total lymphoid irradiation and rabbit anti-thymocyte globulin before the stem cell infusion.
What are the potential side effects?
Potential side effects include reactions to rabbit proteins, changes in blood counts due to radiation or rATG treatment, increased risk of infections, and possible organ inflammation related to the immune system's response.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Therapeutic immunosuppression
Secondary study objectives
Graft survival
Incidence of allograft rejection
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Immune tolerance in HLA-identical kidney transplant recipientExperimental Treatment1 Intervention
We seek to establish immunological tolerance in patients with a pre-existing, well- functioning kidney transplant from an HLA-identical donor. Patients will undergo conditioning with TLI and ATG, followed by infusion of hematopoietic stem cells from the same donor . We will evaluate whether recipients can be withdrawn from immunosuppressive drugs without compromising allograft function. At serial time points, graft function will be monitored, and chimerism will be measured. Weaning of tacrolimus will begin at 6 months, with a goal of drug discontinuation within 12 months if the following conditions are met: (1) chimerism (defined as ≥1% donor type cells among the T cells, B cells, NK cells, and granulocytes) is detectable for at least 180 days, (2) stable graft function (defined as eGFR \>30 mL/min and no greater than sustained 30% change over 3 months from baseline) without clinical rejection episodes is maintained, and (3) no evidence of graft vs. host disease (GVHD).
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,179 Total Patients Enrolled
1 Trials studying Immunological Tolerance
16 Patients Enrolled for Immunological Tolerance
Jeffrey Veale, MDPrincipal InvestigatorProfessor of Urology
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My donor is my identical twin.I do not have any unmanaged ongoing illnesses.I have received transplants for more than one organ.My current kidney transplant has not been rejected.I do not have active infections like hepatitis or HIV.I have positive donor-specific antibodies.I haven't had cancer in the last 5 years, except for certain types.My kidney disease is likely to come back.I haven't had major issues like new cancer, infections, or rejection after my transplant.I have recently used drugs that affect my immune system.I have no known allergies or adverse reactions to rATG or radiation.I am able to care for myself but may not be able to do active work.My body has rejected a kidney transplant that was a good match.I agree to join the study and can give my consent.I received a kidney transplant between 3 months and 5 years ago.My kidney function has worsened by more than 30% in the last 3 months.My liver tests are within the required range.I am 18 or older and have a kidney transplant from a matching living donor.My heart pumps well, with an ejection fraction of 40% or higher.My kidney function has been stable for at least 3 months.I am eligible for a stem cell transplant according to my hospital's rules.I have severe liver scarring due to hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: Immune tolerance in HLA-identical kidney transplant recipient
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.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger