Actively Recruiting
Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor
Led by Alice Bertaina · Updated on 2023-07-17
12
Participants Needed
1
Research Sites
611 weeks
Total Duration
On this page
Sponsors
A
Alice Bertaina
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single center, non-randomized, non-controlled open-label phase 1b/2a trial of performing sequential αβdepleted-HSCT and KT in patients requiring KT to prevent kidney rejection post-KT, in the absence of any post-KT immunosuppression, to abrogate the need for lifelong immunosuppression, the risk of chronic rejection and, ultimately, the need for repeated transplantation.
CONDITIONS
Official Title
Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Anticipated need for kidney transplant due to underlying genetic or immunologic diseases such as SIOD, FSGS, cystinosis, SLE, membranoproliferative glomerulonephritis, renal vasculitis with ANCA positivity, or other genetic kidney diseases
- Patients who have rejected a previous kidney transplant regardless of underlying disease
- Chronic kidney disease stage 3 or greater
- Steroid use less than 0.5 mg/kg/day
- Donor and recipient must be identical for at least one allele at each HLA-A, HLA-B, HLA-Cw, HLA-DQB1, and HLA-DRB1 loci
- Lansky or Karnofsky score greater than 50 (Karnofsky for age 16 years or older, Lansky for under 16 years)
- Able to give informed consent or have a legal authorized representative available
- Male and female subjects of childbearing potential must agree to use effective birth control throughout transplant, immunosuppression, and any chronic graft-versus-host disease
You will not qualify if you...
- Pregnant or lactating females
- Greater than Grade II acute graft-versus-host disease or severe, unmanaged extensive chronic graft-versus-host disease from a previous transplant
- Liver dysfunction with ALT/AST over 10 times normal or direct bilirubin over 3 times normal
- Unmanageable kidney dysfunction despite dialysis
- Severe cardiovascular disease unresponsive to treatment, including left ventricular ejection fraction below 40% or severe diastolic dysfunction
- Current active infection, except well-controlled HIV, hepatitis B, or cured/treated hepatitis C
- Serious uncontrolled medical disorders other than the primary kidney disease
- Lack of informed consent
- Any severe concurrent disease increasing risk during study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94305
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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