Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair

NCT ID: NCT04896567

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2024-12-30

Brief Summary

Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.

Detailed Description

Endothelial dysfunction is central to the pathophysiology of vascular ischemia, bacterial sepsis, toxin-induced thrombotic microangiopathy, and antibody-mediated kidney transplant rejection and often manifest with renal failure. With each of these diagnoses circulating components of the complement cascade bind to endothelial cells and induce disease progression through anaphylactic cellular messaging, monocyte homing, and direct cell membrane disruption. In response to injury during embryologic development avascular metanephric blastema initiate endothelial differentiation. Although circulating hematopoietic progenitor cells have shown therapeutic promise they incorporate into renal vasculature at very low density.

Conditions

Kidney Diseases; Endothelial Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intervention

Patients will have kidney biopsy designated for cell isolation and culture.

Group Type: EXPERIMENTAL

Cell isolation

Intervention Type: DIAGNOSTIC_TEST

Tissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells.

Interventions

Cell isolation

Tissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Only patients who have a clinical indication for kidney biopsy will be considered.
• All subjects will be at least 18 years of age and may be of any gender.
• Patients undergoing a native or kidney transplant biopsy will be considered.

Exclusion Criteria

• Patients not undergoing a kidney biopsy will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrew Michael Siedlecki

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

awaiting IRB approval

Identifier Type: -

Identifier Source: org_study_id