Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair

Endothelial Dysfunction Clinical Trial

Official title:

Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04896567
• Other study ID #: awaiting IRB approval
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 21, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Kidney Diseases

Intervention

Diagnostic Test:
• Cell isolation
Tissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell growth	Tissue will be isolated and cell viability will be documented by rate of colony growth over one week per patient enrolled.	1 week
Secondary	Kidney disease progression	Isolated cell growth will be compared to serum creatinine of patients	3 years