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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04896567
Other study ID # awaiting IRB approval
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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