Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair

Phase 1

Withdrawn

• Conditions: Kidney Diseases; Endothelial Dysfunction
• Interventions: Diagnostic Test: Cell isolation

• Registration Number: NCT04896567
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-21
• Study Start: 2022-01-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-31
• Last Update Posted: 2022-08-03
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Cell isolation	Patients will have kidney biopsy designated for cell isolation and culture.

Primary Outcome Measures

Name	Time	Method
Cell growth	1 week	Tissue will be isolated and cell viability will be documented by rate of colony growth over one week per patient enrolled.

Secondary Outcome Measures

Name	Time	Method
Kidney disease progression	3 years	Isolated cell growth will be compared to serum creatinine of patients

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States