Biorepository and Registry for Plasma Exchange Patients

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Charles M Knudson
Study ID
NCT05004493
Status
Recruiting
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Conditions

  • Antibody-mediated Rejection
  • CIDP
  • NMO Spectrum Disorder
  • TTP

Eligibility Criteria

Sex
ALL
Age
12 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

Patients who have immune mediated diseases commonly undergo plasma exchange (PLEX) procedures to remove pathological substances, typically believed to be antibodies. At our facility about 400 of these procedures are performed annually on 40-60 different patients. These procedures are considered within the standard of care for these patients and are covered by insurance. This study will not influence the treatment plan for subjects who participate in this study. The goal of the study is to collect and cryopreserve blood biospecimens (plasma, serum, PBMCs) for current and future studies. Any patient undergoing plasma exchange procedures will be eligible for the study. Patients or the legally authorized representative (LAR) will be consented for the study as soon as feasible after the are referred to DeGowin for plasma exchange. The immediate objective of the study is to examine antibody levels (IgG/IgM) and BAFF levels in the blood of these patients over the course of the plasma exchange treatments. Specimens and clinical data will be collected such that other immune factors that may regulate B cell survival, proliferation and antibody secretion can be studied. Another goal of the study is to isolate and cryopreserve PBMCs at different points during the patient's treatment. This would allow the study of immune cells that may mediate these diseases. The study will also follow pathological antibodies over time in these patients so biospecimens can be obtained even after the completion of their course of plasma exchange treatments. The collection of biospecimens and clinical information from these subjects will help us understand the impact of plasma exchange on both normal and pathological immune factors in a variety of patients undergoing these procedures.

Key Dates

Start date
Jul 28, 2021
Status verified
May 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2040

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Plasma arm
    Patients receiving plasma as one of the main replacement fluids
  • Arm: No Plasma
    Patients receiving saline and/or 5% albumin as the replacement fluid.

Primary Outcome Measure

IgG and IgM antibody levels [ Time Frame: Levels over the course of treatment will be compared. Typically 1-2 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
DeGowin blood CenterIowa CityIowa52242
charles knudson, MD;PhD

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DeGowin blood Center· Iowa City, IA

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