Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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Study Matches
BK With VST for Kidney Transplant Patients
This study measures the safety, feasibility, and efficacy of viral-specific T cells (VST)
against BK Virus (BKV) in adult kidney transplant recipients. Participants are expected to be
on study for 52 weeks.
Sandesh Parajuli
All
18 Years to 75 Years old
Phase 1
This study is also accepting healthy volunteers
NCT05042076
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Inclusion Criteria:
• Age18 ≤ 75 years
• Have BKV infection/viremia following kidney transplantation, where BKV viremia is
defined as positive BKV qPCR (≥ 250 copies)
• Have evidence of invasive BKV infection (BK Nephropathy)
• Experience one of the following:
• New, persistent and/or worsening BKV-related symptoms, signs and/or markers of
end organ compromise despite being on lower immunosuppressive medication
• Adverse effects of lower immunosuppressive medications (e.g., dnDSA, biopsy
proven rejection)
• Eligible Donor
• Provide Written informed consent
Exclusion Criteria:
• Non-kidney organ transplant recipient
• Patient with acute rejection of the kidney allograft at time of T-cell transfer
• Patient receiving steroids (>0.5 mg/kg body weight (BW) prednisone equivalent) at the
time of T-cell transfer
• Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive
monoclonal antibodies within 28 days prior to T-cell transfer
• Extra renal tissue invasive BK infection
• Concomitant enrollment in another clinical trial interfering with endpoints of this
study
• Any medical condition which could compromise participation in the study according to
the investigator's assessment
• Known HIV infection
• Female patient who is pregnant or breast-feeding, or adult of reproductive potential
not willing to use an effective method of birth control during study treatment Note:
Women of childbearing potential must have a negative urine pregnancy test at study
entry.
• Patients unwilling or unable to comply with the protocol or unable to give informed
consent
Donor Eligibility
• ≥ 18 years old
• Available and capable of undergoing a single standard 2 blood volume leukapheresis
• HLA Compatible (see Donor selection priority below):
• Original kidney transplant donor
• Fully HLA matched family member (6/6 HLA match considering HLA-A, HLA-B and
HLA-DRB1 genes)
• Partially matched family member (≥ 2/6 HLA match, considering HLA-A, HLA-B and
HLA-DRB1 genes)
• BK IgG seropositive
• Meets the criteria for donor eligibility defined in the UW Program for Advanced Cell
Therapy Standard Operating Policies and Procedures for Donor Evaluation and
Eligibility Determination for the Donation of Viral Specific T Cells, which is in
compliance with FACT standards for Immune Effector Cells, and 21 CFR 1271, subpart C.
• Provide written informed consent
Donor selection priority: The original kidney donor will be the first choice of donor
peripheral mononuclear cells. If the original donor is not available or does not meet all
donor eligibility criteria, alternative related donors will be selected, with preference
for fully matched related donors (6/6 HLA match, considering HLA-A, -B, and -DRB1 genes)
over related donors with partial HLA match (≥ 2/6 HLA match, considering HLA-A, -B, and
-DRB1 genes).
Note that if the selected donor is related, but not a biological parent or child of the
recipient (i.e., at least haploidentical), then high resolution testing of HLA-A and HLA-B
will be performed on donor and recipient (if high resolution HLA genotyping not already
available in the medical record). If the degree of matching at high resolution reveals a
less favorable match than an alternative donor, then prioritization of the alternative
donor will occur.
Kidney replaced by transplant, Other, Kidney Transplant Infection, BK Virus Infection, Infections, Immune System & Allergies, Kidney Disease & Urinary
This study is called the Microbes and Respiratory Illnesses (MARI) Study. Children growing up
on farms are exposed to many types of microbes that could be beneficial. It is thought that
increased exposure to certain types of microbes early in life helps to develop a healthy
immune system and reduce the risk for severe common cold illnesses, breathing problems, and
allergies.
James Gern
All
4 Years to 12 Years old
N/A
This study is also accepting healthy volunteers
NCT06059027
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Inclusion Criteria:
1. Participant and/or parent guardian must be able to understand and provide informed
consent
2. Children ages 4-12 years of age
3. Cohort 1: Family is self-identified as Plain community member
4. Cohort 2: Madison-area children with parental report of doctor-diagnosed asthma
5. Cohort 3: Madison-area children with no history of asthma by parental report
6. Cohort 4: Madison-area children who have an active respiratory illness
Exclusion Criteria:
1. Inability or unwillingness of a participant to give written informed consent or comply
with study protocol
2. Chronic sinusitis (frequent sinus infections)
3. Plans to move out of the area before completing the study
4. Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality or
interpretation of the data obtained from the study
5. Enrolled family member
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