Transplantation, KidneyNCT01150487
Paired Marrow Aspirations to Assess Assays in Sensitized Renal Allograft Recipients
A study testing bone marrow aspirations and lymph node collection in people with Transplantation, Kidney and Living Donors, run by Mayo Clinic at 1 site in United States.
Trial summary
The aim of this study is to determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Transplantation, Kidney, Living Donors, Kidney Transplant Recipients
- What is being tested?
- bone marrow aspirations and lymph node collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2010to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre or post renal transplant recipients.
- Renal transplant donors.
- Those who give voluntary written informed consent before performance of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Any patient currently receiving systemic anticoagulation therapy with heparin or coumadin.
- Patient has a platelet count of <30 x 10(9)/L within 14 days before enrollment.
- Patient has an absolute neutrophil count of ANC<1.0 x 10(9)/L within 14 days before enrollment.
- Patient has received other investigational drugs within14 days before enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Diagnosed or treated for malignancy within 5 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Contraindication to kidney transplantation or donation-active infection, comorbid medical conditions, etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paired Bone Marrow Aspirations to Assess the Variability of Allo-ELISPOT and Allo-Specificities Assays in Sensitized Renal Allograft Recipients
The aim of this study is to determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes.
Read the detailed description
The aim of this risk protocol is to determine the variability of the AlloElispot and Allospecificities assay.
Our group has developed a number of assays to assess the immune cell population in our transplant population. This has included: 1) the number of donor-specific alloantibody (DSA) secreting bone marrow derived plasma cells (AlloELISPOT assay), 2) the function of DSA-secreting Plasma cells (Allospecificities assay), 3)Culture of plasma cells in human stromal cells to produce specific HLA antibodies and tetanus antibodies, 4) Understand the critical pathways for the survival and function of plasma cells, 5)Characterize the different phenotypes and genotypes of the plasma cell, 6)Phenotype analyses of the immune cell population using flow cytometry and/or mass spectrometry (ie. cytometry by time of flight/CyTOF), 7)Functional assessments of T and B-cells, and 8)T-cell receptor diversity.
These assays were developed over the years and already have provided an important means of testing new therapeutic protocols aimed at controlling DSA production. It is important to note that repeated attempts to isolate PCs from peripheral blood have been unsuccessful (PCs are extremely rare in peripheral blood) and the bone marrow is the only accessible source of PCs.
It is now clear to that we have reached a point that we must validate these assays (coefficient of variation, etc), in order to appropriately evaluate data derived from these assays. Inter-assay variability can be assessed by performing two paired assays in the same patient. This could be done in two ways-paired bone marrow aspirations separated by time or two bone marrow aspirations performed at the same time. We have decided to pursue the latter approach. We will do both marrows either at the time of transplantation or while they are undergoing a surgical procedure. Lymph node retrieval will also be performed at the time for abstraction of immune cells for additional analysis. We believe that this is safe and will be well-tolerated and will provide the data that we need to validate the assays.
- Being tested
- bone marrow aspirations, lymph node collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone marrow aspirationsProcedure or surgery
A bone marrow aspiration from each hip bone of the patients.
lymph node collectionProcedure or surgery
An Iliac lymph node collection.
| Study group | Role | What they receive |
|---|---|---|
| Kidney recipients or kidney donors | Experimental | Patients who have had a Kidney transplant or are undergoing a kidney transplant. Kidney donors. Receives: Procedure: bone marrow aspirations; Procedure: lymph node collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes.
Measured: 1 week Post bone marrow and lymph node collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study start5 Oct 2010
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation, KidneyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Stegall, Mayo Clinic
- Investigators
- Mark Stegall, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150487
- Sponsor's protocol ID
- 10-002572
- Other IDs
- R21AI125719
- Status last verified
- Dec 2025
- First submitted
- 23 Jun 2010
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Bone Marrow Aspirations to Assess the Variability of Allo-ELISPOT and Allo-Specificities Assays in Sensitized Renal Allograft Recipients
- ClinicalTrials.gov ID
- NCT01150487
- Acronym / sponsor ID
- 10-002572
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 5 Oct 2010 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes.
Detailed description
The aim of this risk protocol is to determine the variability of the AlloElispot and Allospecificities assay.
Our group has developed a number of assays to assess the immune cell population in our transplant population. This has included: 1) the number of donor-specific alloantibody (DSA) secreting bone marrow derived plasma cells (AlloELISPOT assay), 2) the function of DSA-secreting Plasma cells (Allospecificities assay), 3)Culture of plasma cells in human stromal cells to produce specific HLA antibodies and tetanus antibodies, 4) Understand the critical pathways for the survival and function of plasma cells, 5)Characterize the different phenotypes and genotypes of the plasma cell, 6)Phenotype analyses of the immune cell population using flow cytometry and/or mass spectrometry (ie. cytometry by time of flight/CyTOF), 7)Functional assessments of T and B-cells, and 8)T-cell receptor diversity.
These assays were developed over the years and already have provided an important means of testing new therapeutic protocols aimed at controlling DSA production. It is important to note that repeated attempts to isolate PCs from peripheral blood have been unsuccessful (PCs are extremely rare in peripheral blood) and the bone marrow is the only accessible source of PCs.
It is now clear to that we have reached a point that we must validate these assays (coefficient of variation, etc), in order to appropriately evaluate data derived from these assays. Inter-assay variability can be assessed by performing two paired assays in the same patient. This could be done in two ways-paired bone marrow aspirations separated by time or two bone marrow aspirations performed at the same time. We have decided to pursue the latter approach. We will do both marrows either at the time of transplantation or while they are undergoing a surgical procedure. Lymph node retrieval will also be performed at the time for abstraction of immune cells for additional analysis. We believe that this is safe and will be well-tolerated and will provide the data that we need to validate the assays.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney recipients or kidney donors | Experimental | Procedure: bone marrow aspirations, Procedure: lymph node collectionPatients who have had a Kidney transplant or are undergoing a kidney transplant. Kidney donors. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pre or post renal transplant recipients.
- Renal transplant donors.
- Those who give voluntary written informed consent before performance of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Key exclusion criteria (7 listed)
- Any patient currently receiving systemic anticoagulation therapy with heparin or coumadin.
- Patient has a platelet count of <30 x 10(9)/L within 14 days before enrollment.
- Patient has an absolute neutrophil count of ANC<1.0 x 10(9)/L within 14 days before enrollment.
- Patient has received other investigational drugs within14 days before enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone marrow aspirationsA bone marrow aspiration from each hip bone of the patients. | Procedure or surgery | Kidney recipients or kidney donors |
| lymph node collectionAn Iliac lymph node collection. | Procedure or surgery | Kidney recipients or kidney donors |
Primary outcome
To determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes.
Time frame: 1 week Post bone marrow and lymph node collection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Stegall, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone marrow aspirations and lymph node collection in people with Transplantation, Kidney and Living Donors, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes. (time frame: 1 week Post bone marrow and lymph node collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.