Biorepository and Registry for Plasma Exchange Patients

NCT05004493 | Recruiting

• 1 other identifier: 202104462
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

plasma exchange; plasmapheresis

Outcome Measures

Primary Outcomes (1)

• IgG and IgM antibody levels

  The effect of replacement fluids on IgG and IgM antibody levels will be examined.

  Levels over the course of treatment will be compared. Typically 1-2 weeks.

Study Arms (2)

Plasma arm

Patients receiving plasma as one of the main replacement fluids

No Plasma

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

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients \> 12 years old who are undergoing plasma exchange therapy.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Charles M Knudson: lead

Study Sites (1)

DeGowin blood Center

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 23233554 BACKGROUND

• 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.

  PMID: 24172059 BACKGROUND

• 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.

  PMID: 33333233 BACKGROUND

• 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.

  PMID: 11509691 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples collected during and after the course of plasma exchange treatment.

MeSH Terms

Conditions

Neuromyelitis Optica; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases; Polyradiculoneuropathy; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Charles Knudson, MD, PHD

CONTACT

+1 319 467-5129; c-knudson@uiowa.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: July 28, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

US (1)