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?

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{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

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 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]

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]

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]

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]

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]

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]

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]

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. England pubmed.ncbi.nlm.nih.gov

A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

[Bone marrow aspiration: practical aspects]. [2006]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Value and limitations of the combined cyto-histological study of hematopoietic bone marrow. 200 cases]. [2006]

4. Germany pubmed.ncbi.nlm.nih.gov

Complications associated with improper palpation-guided iliac bone marrow biopsy tracts identified on follow-up imaging. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Accuracy and relative value of bone marrow aspiration in the detection of lymphoid infiltration in non-Hodgkin lymphoma. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Bone marrow biopsy morbidity and mortality. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Bone marrow aspiration for diagnostic purposes]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Bone marrow sampling. [2004]

9. England pubmed.ncbi.nlm.nih.gov

Penetrating injury of the ascending aorta complicating a sternal biopsy. [2018]