Biorepository and Registry for Plasma Exchange Patients

NCT ID: NCT05004493

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2040-12-31

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Plasma arm

Patients receiving plasma as one of the main replacement fluids

No interventions assigned to this group

No Plasma

Patients receiving saline and/or 5% albumin as the replacement fluid.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Pts undergoing plasma exchange therapy are eligible to be in this protocol

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles M Knudson

OTHER

Sponsor Role: lead

Responsible Party

Charles M Knudson

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

DeGowin blood Center

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Charles Knudson, MD, PHD

Role: CONTACT

c-knudson@uiowa.edu

+1 319 467-5129

Facility Contacts

charles knudson, MD;PhD

Role: primary

References

Winters JL. Plasma exchange: concepts, mechanisms, and an overview of the American Society for Apheresis guidelines. Hematology Am Soc Hematol Educ Program. 2012;2012:7-12. doi: 10.1182/asheducation-2012.1.7.

Reference Type: BACKGROUND

PMID: 23233554 (View on PubMed)

Reeves HM, Winters JL. The mechanisms of action of plasma exchange. Br J Haematol. 2014 Feb;164(3):342-51. doi: 10.1111/bjh.12629. Epub 2013 Oct 30.

Reference Type: BACKGROUND

PMID: 24172059 (View on PubMed)

Mockel T, Basta F, Weinmann-Menke J, Schwarting A. B cell activating factor (BAFF): Structure, functions, autoimmunity and clinical implications in Systemic Lupus Erythematosus (SLE). Autoimmun Rev. 2021 Feb;20(2):102736. doi: 10.1016/j.autrev.2020.102736. Epub 2020 Dec 14.

Reference Type: BACKGROUND

PMID: 33333233 (View on PubMed)

Schiemann B, Gommerman JL, Vora K, Cachero TG, Shulga-Morskaya S, Dobles M, Frew E, Scott ML. An essential role for BAFF in the normal development of B cells through a BCMA-independent pathway. Science. 2001 Sep 14;293(5537):2111-4. doi: 10.1126/science.1061964. Epub 2001 Aug 16.

Reference Type: BACKGROUND

PMID: 11509691 (View on PubMed)

Other Identifiers

202104462

Identifier Type: -

Identifier Source: org_study_id