Identification of Non-gal, Non-HLA Antigens in Patients Implanted With Xenogenic Material
May 1, 2025 updated by: Leigh G. Griffiths, Mayo Clinic
This study involves collecting serum samples from patients presenting for aortic valve replacement at Mayo Clinic, Rochester, MN.
Serum samples will be collected pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and between 12-18 months post-operatively.
The patients antibodies in these serum samples will be used to capture proteins from the same type of tissue their replacement heart valves are made from (i.e., bovine/porcine pericardium - a non-human tissue which is currently used to make glutaraldehyde-fixed heart valves).
The captured proteins will be identified, and compared over time (i.e., 0, 1, 3 and 12 months) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Protein G HP SpinTrap columns will be used to capture IgG antibodies from patient serum pre-implant, between 2 weeks-3 months, between 3-11 months and between 12-18 months post-implant.
These antibodies will be cross-linked to the column and then protein extracted from implant tissue (ie Native bovine/porcine pericardium) will be deglycosylated and run through the column.
Antigenic proteins will be trapped and non-antigenic proteins will be washed through the column.
These antigenic proteins will be eluted off the column and identified using LC-MS/MS.
The proteins identified in the pre-implant elutant will be compared to the proteins in post-implant elutant to identify xenoantigens.
Success criteria will be method validation by identification of previously known and new currently unknown xenoantigens.
Study Type
Observational
Enrollment (Actual)
197
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85054
- Mayo Clinic Arizona
-
-
Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic Florida
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Adult males and females who will receive either a mechanical or biological heart valve implant
Description
Inclusion Criteria:
- patients who will receive either a biological or mechanical heart valve
Exclusion Criteria:
- Currently receiving therapy for cancer requiring treatment with concurrent radiotherapy and/or chemotherapy
- Cancer in remission for less than 5 years if previously treated with radiotherapy and/or chemotherapy
- Previous tissue valve implants
- Current pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Biological Heart Valve
Participants receiving a biological heart valve
|
blood will be drawn at pre-operation, between 2 weeks and 3 months, between 3-11 months (optional; we will collect a sample if the patient returns to Mayo Clinic for any other non-study related visit), and between 12-18 months post-operatively.
|
|
Mechanical Heart Valve
Participants receiving a mechanical heart valve
|
blood will be drawn at pre-operation, between 2 weeks and 3 months, between 3-11 months (optional; we will collect a sample if the patient returns to Mayo Clinic for any other non-study related visit), and between 12-18 months post-operatively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify Non-gal, non-HLA protein antigens in patients that have received xenogenic tissue implant.
Time Frame: Approximately 12-18 months post-operatively
|
The captured proteins will be identified, and compared over time (i.e., pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and 12-18 months post-operatively) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards.
|
Approximately 12-18 months post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leigh G Griffiths, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Actual)
September 5, 2024
Study Completion (Actual)
September 5, 2024
Study Registration Dates
First Submitted
June 22, 2021
First Submitted That Met QC Criteria
June 22, 2021
First Posted (Actual)
June 25, 2021
Study Record Updates
Last Update Posted (Actual)
May 6, 2025
Last Update Submitted That Met QC Criteria
May 1, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-007803
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.