500 Participants Needed

Bone Marrow Aspiration for Kidney Transplant Rejection

NY
Overseen ByNong Yowe Braaten
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain blood thinners like heparin or coumadin.

What data supports the effectiveness of the treatment Bone Marrow Aspiration for Kidney Transplant Rejection?

Bone marrow aspiration is a valuable diagnostic tool for evaluating bone marrow health and detecting conditions like lymphomas and other blood disorders. While the studies focus on its diagnostic use, the ability to accurately assess bone marrow health may indirectly support its potential role in monitoring or managing kidney transplant rejection.12345

Is bone marrow aspiration generally safe for humans?

Bone marrow aspiration is generally considered safe, but it can have rare complications like bleeding, especially in patients with blood disorders or those on certain medications. Serious adverse events are uncommon, but they can occur, such as a reported case of injury to the aorta during a sternal biopsy.16789

How does bone marrow aspiration differ from other treatments for kidney transplant rejection?

Bone marrow aspiration is unique because it involves taking a sample of bone marrow (the soft tissue inside bones) to help diagnose or understand conditions, rather than directly treating kidney transplant rejection. This procedure is typically used for diagnosing blood-related conditions and is not a standard treatment for kidney transplant rejection, which usually involves medications to suppress the immune system.12578

What is the purpose of this trial?

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.

Research Team

Mark D. Stegall, M.D. - Doctors and ...

Mark Stegall, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for kidney transplant recipients with antibodies against their donors (sensitized) and the living donors themselves. Participants must consent to study procedures not part of normal care. Excluded are those with low neutrophil or platelet counts, recent investigational drug use, current systemic anticoagulation therapy, certain cancer histories within 5 years, or serious medical/psychiatric conditions.

Inclusion Criteria

People who have donated a kidney for a transplant.
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
I have antibodies against a kidney transplant as shown by a specific test.

Exclusion Criteria

I haven't had cancer, except for certain skin cancers or low-risk prostate cancer treated over 5 years ago.
Patient has an absolute neutrophil count of ANC<1.0 x 10(9)/L within 14 days before enrollment
I am currently on blood thinners like heparin or coumadin.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Bone Marrow Aspiration

Paired bone marrow aspirations are performed to assess the variability of Allo-ELISPOT and Allo-Specificities assays

1 day
1 visit (in-person)

Lymph Node Retrieval

Lymph node retrieval is performed for abstraction of immune cells for additional analysis

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after procedures

4 weeks

Treatment Details

Interventions

  • Bone Marrow Aspirations
Trial Overview The study tests the validity of two assays on bone marrow from sensitized kidney transplant recipients to understand the higher rejection risk in these patients. It involves marrow aspirations from both recipients and living donors to assess immune responses.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Kidney recipients or kidney donorsExperimental Treatment2 Interventions
Patients who have had a Kidney transplant or are undergoing a kidney transplant. Kidney donors.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mark Stegall

Lead Sponsor

Trials
4
Recruited
1,700+

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Findings from Research

The powered bone marrow aspiration and biopsy device significantly reduced patient-reported pain during needle insertion (2.6 vs 4.1 on a pain scale) and decreased procedural time (100 seconds vs 224 seconds) compared to the traditional manual method, indicating improved patient comfort and efficiency.
Specimens obtained with the powered device were larger and of better quality (25.4 mmยฒ vs 11.9 mmยฒ), enhancing diagnostic yield and potentially reducing the need for repeat procedures, while no complications were reported in either method.
A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy.Swords, RT., Anguita, J., Higgins, RA., et al.[2022]
Bone marrow aspiration is a crucial diagnostic tool for assessing blood cell production in the bone marrow, providing essential information for diagnosing blood-related diseases.
Accurate smear-sampling and staining techniques are vital for correctly identifying bone marrow cells, which aids in understanding various hematological conditions.
[Bone marrow aspiration: practical aspects].Murakami, N.[2006]
In a study of 200 patients, both bone marrow aspiration and biopsy were found to be effective, with 76% of cases showing equivalent results, but the combination of both methods provided greater diagnostic confidence.
Bone marrow biopsy was the only diagnostic method in 12% of cases, while aspiration was superior in detecting small malignant infiltrates, highlighting the importance of using both techniques for accurate diagnosis of various hematological disorders.
[Value and limitations of the combined cyto-histological study of hematopoietic bone marrow. 200 cases].Delacrรฉtaz, F., Schmidt, PM.[2006]

References

A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy. [2022]
[Bone marrow aspiration: practical aspects]. [2006]
[Value and limitations of the combined cyto-histological study of hematopoietic bone marrow. 200 cases]. [2006]
Complications associated with improper palpation-guided iliac bone marrow biopsy tracts identified on follow-up imaging. [2022]
Accuracy and relative value of bone marrow aspiration in the detection of lymphoid infiltration in non-Hodgkin lymphoma. [2022]
Bone marrow biopsy morbidity and mortality. [2022]
[Bone marrow aspiration for diagnostic purposes]. [2006]
Bone marrow sampling. [2004]
Penetrating injury of the ascending aorta complicating a sternal biopsy. [2018]
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