Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
Primary Purpose
Kidney Diseases, Endothelial Dysfunction
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cell isolation
Sponsored by
About this trial
This is an interventional basic science trial for Kidney Diseases
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.
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Patients will have kidney biopsy designated for cell isolation and culture.
Outcomes
Primary Outcome Measures
Cell growth
Tissue will be isolated and cell viability will be documented by rate of colony growth over one week per patient enrolled.
Secondary Outcome Measures
Kidney disease progression
Isolated cell growth will be compared to serum creatinine of patients
Full Information
NCT ID
NCT04896567
First Posted
August 31, 2018
Last Updated
July 31, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04896567
Brief Title
Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
Official Title
Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Superseded by a separate study
Study Start Date
January 21, 2022 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Endothelial Dysfunction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Consecutive patients will be consented to obtain kidney biopsy material.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients will have kidney biopsy designated for cell isolation and culture.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cell isolation
Intervention Description
Tissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells.
Primary Outcome Measure Information:
Title
Cell growth
Description
Tissue will be isolated and cell viability will be documented by rate of colony growth over one week per patient enrolled.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Kidney disease progression
Description
Isolated cell growth will be compared to serum creatinine of patients
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
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