Bone Marrow Aspiration for Kidney Transplant Rejection

Overseen By Nong Yowe Braaten

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mark Stegall

Must not be taking: Heparin, Coumadin, others

Disqualifiers: Low platelets, Low neutrophils, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the immune system in bone marrow and lymph nodes reacts in individuals donating or receiving a kidney transplant. By analyzing these immune cells through bone marrow aspirations (a procedure to collect and examine bone marrow), researchers hope to improve transplant management and reduce rejection risk. Suitable candidates include those who have had or are about to have a kidney transplant, as well as kidney donors. Participants must be able to give informed consent and should not be on certain blood-thinning medications or have low blood cell counts. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance transplant success rates.

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 prior data suggests that bone marrow aspirations are safe for kidney transplant patients?

Research has shown that bone marrow aspiration is generally safe for patients. This procedure often diagnoses blood disorders. Rare complications, such as bleeding, can occur, especially in individuals with blood conditions. Performing the procedure at the back of the hip bone helps reduce pain and other risks.

Overall, patients generally tolerate bone marrow aspiration well. However, those with certain health issues should discuss potential risks with their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Bone marrow aspiration is unique because it offers a novel approach to addressing kidney transplant rejection by potentially modulating the immune system. Unlike traditional treatments that often involve immunosuppressive drugs to prevent rejection, which can have significant side effects, bone marrow aspiration targets the body's own regenerative and immune-modulating capabilities. Researchers are excited about this because it might reduce the need for long-term medication, lower the risk of infection, and improve overall transplant success rates by promoting tolerance of the new kidney.

What evidence suggests that bone marrow aspirations are effective for assessing immune profiles in kidney transplant patients?

Research has shown that bone marrow aspiration primarily diagnoses diseases related to blood and bone marrow. This procedure involves taking a sample of the soft tissue inside bones to study the cells. In this trial, researchers use bone marrow aspiration to examine immune cells in patients who have had a kidney transplant or are undergoing one, including kidney donors. The aim is to understand how the body's immune system might reject or accept a new kidney. Early results suggest that examining these immune cells helps doctors better understand transplant rejection. This knowledge could improve the management of transplant rejection in the future. ^{1 6 7 8 9}

Who Is on the Research Team?

Mark Stegall, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Kidney recipients or kidney donors Experimental Treatment 2 Interventions

Patients who have had a Kidney transplant or are undergoing a kidney transplant. Kidney donors.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bone marrow aspiration: practical aspects]. Murakami, N.[2006]

Bone marrow aspiration is a safe diagnostic tool for hematological diseases, but it is not recommended for patients with bleeding disorders due to potential complications.

Proper training and supervision by experienced physicians are essential to minimize risks and ensure high-quality care, especially in pediatric patients undergoing the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bone marrow aspiration for diagnostic purposes]. Letestu, R., Valensi, F.[2006]

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 mm² vs 11.9 mm²), enhancing diagnostic yield and potentially reducing the need for repeat procedures, while no complications were reported in either method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 has a sensitivity of 69% and specificity of 86% for detecting non-Hodgkin lymphoma, with higher sensitivity (82%) for indolent types compared to aggressive types (40%).

The study found that bone marrow aspiration can detect cases of lymphoma that bone marrow biopsy might miss, highlighting its complementary role in diagnosis, especially since 10% of cases showed positive aspiration results despite negative biopsy results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and relative value of bone marrow aspiration in the detection of lymphoid infiltration in non-Hodgkin lymphoma. Musolino, A., Guazzi, A., Nizzoli, R., et al.[2022]

Bone marrow sampling is a crucial procedure for diagnosing various hematologic conditions, including anemia and leukocytosis, and is typically performed at the iliac crest using needle aspiration or biopsy.

To ensure safety and effectiveness, the procedure should be conducted by a skilled technician with proper patient education, local anesthesia, and strict aseptic techniques, while being mindful of contraindications like infection or coagulation issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow sampling. Paulman, PM.[2004]

In a study of 443 iliac bone marrow biopsy procedures, improper palpation-guided biopsy tracts were found to be significantly associated with complications, including bleeding and fractures, highlighting the importance of proper technique.

All complications occurred in procedures with improper tracts, and those performed by providers with less than 12 months of experience were more likely to result in improper tracts, suggesting that training and experience are crucial for minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications associated with improper palpation-guided iliac bone marrow biopsy tracts identified on follow-up imaging. Khdhir, M., Jabbour, Y., Azzi, C., et al.[2022]

In a survey of 54,890 bone marrow biopsies conducted from 1995 to 2001, 26 adverse events were reported, including one death directly linked to the procedure, highlighting the potential risks involved.

The most common and serious complication was hemorrhage, occurring in 14 patients, with risk factors including myeloproliferative disorders and the use of aspirin or warfarin, indicating that certain patient conditions may increase the likelihood of severe outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow biopsy morbidity and mortality. Bain, BJ.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Value and limitations of the combined cyto-histological study of hematopoietic bone marrow. 200 cases]. Delacrétaz, F., Schmidt, PM.[2006]

Bone marrow aspiration and trephine biopsy are generally safe procedures, but there can be rare serious complications associated with them.

This report highlights a rare case of ascending aortic injury that occurred following a sternal trephine biopsy, emphasizing the need for awareness of potential risks even in commonly performed procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Penetrating injury of the ascending aorta complicating a sternal biopsy. Lahdhili, H., Lajmi, M., Bey, M., et al.[2018]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559232/

Bone Marrow Aspiration and Biopsy - StatPearls - NCBI - NIH Bone marrow aspiration and biopsies are often performed both in the inpatient and outpatient settings for the diagnosis of a multitude of hematologic disorders.

2. mayoclinic.org mayoclinic.org/tests-procedures/bone-marrow-biopsy/about/pac-20393117

Bone marrow biopsy and aspiration Bone marrow aspiration and bone marrow biopsy are procedures to collect and examine bone marrow — the spongy tissue inside some of your larger ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5715543/

Contribution to diagnosis and treatment of bone marrow ... The purpose of the work was to assess the contribution to diagnosis and/or treatment (CDT) of bone marrow aspiration (BMA) in the critically ill patient.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138314700099

Bone marrow mesenchymal stem cell aspirates from ... The most common method to obtain human mesenchymal stem cells (MSCs) is bone marrow aspiration from the iliac crest, but MSCs have also been isolated from ...

5. cancer.org cancer.org/cancer/diagnosis-staging/tests/biopsy-and-cytology-tests/bone-marrow-biopsy-and-aspiration.html

Bone Marrow Biopsy and Aspiration Bone marrow biopsy and aspiration are procedures to help diagnose blood and bone marrow diseases and cancers like leukemia or lymphoma.

6. withpower.com withpower.com/trial/phase-5-2010-7b235

Bone Marrow Aspiration for Kidney Transplant Rejection Bone marrow aspiration is generally considered safe, but it can have rare complications like bleeding, especially in patients with blood disorders or those ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40663031/

Clinical trial assessing the safety and efficacy of human ... Background aims: This study evaluated the safety and efficacy of allogenic human bone marrow-derived mesenchymal stem cell (hBM-MSC) therapy in kidney ...

8. emedicine.medscape.com emedicine.medscape.com/article/207575-overview

Bone Marrow Aspiration and Biopsy The posterior superior iliac crest (see the image below) is the most commonly employed site for reasons of safety, decreased risk of pain, and ...

9. mayo.edu mayo.edu/research/clinical-trials/cls-20126677

Paired Marrow Aspirations to Assess Assays in Sensitized ... The aim of this study is to determine the validity of two tests on bone marrow of sensitized kidney transplant recipients in order to better understand why ...