Back to resultsCell-based Therapy for the Treatment of Kidney Disease (CTKD)
Primary Purpose
Kidney Diseases
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
endothelial progenitor cell
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Diseases
Eligibility Criteria
Inclusion Criteria:
- Enrolled patients will have endothelial progenitor cells previously acquired.
Exclusion Criteria:
- Patients without previously acquired endothelial progenitor cells will be excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Patients will be given autologous endothelial progenitor cells
Outcomes
Primary Outcome Measures
Safety of progenitor cell delivery
Serum creatinine will be measured after cell delivery
Secondary Outcome Measures
Full Information
NCT ID
NCT04187625
First Posted
December 3, 2019
Last Updated
July 25, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04187625
Brief Title
Cell-based Therapy for the Treatment of Kidney Disease
Acronym
CTKD
Official Title
Cell-based Therapy for the Treatment of Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Endothelial progenitor cells derived from and delivered to the renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells from the kidney can transition to a phenotype that promotes endothelial repair.
Detailed Description
This is an interventional study involving patients that have a diagnosis of chronic kidney disease. Patients will have at least stage 3 chronic kidney disease stage or greater. Kidney-derived endothelial progenitor cells will have been obtained using associated protocols that are currently approved by the Partners Human Research Committee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open label single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients will be given autologous endothelial progenitor cells
Intervention Type
Biological
Intervention Name(s)
endothelial progenitor cell
Intervention Description
Kidney-derived endothelial progenitor cells will be delivered percutaneously to the kidney blood supply.
Primary Outcome Measure Information:
Title
Safety of progenitor cell delivery
Description
Serum creatinine will be measured after cell delivery
Time Frame
180 days
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:
Enrolled patients will have endothelial progenitor cells previously acquired.
Exclusion Criteria:
Patients without previously acquired endothelial progenitor cells will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew M Siedlecki, MD
Phone
314-809-2879
Email
asiedlecki@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Siedlecki, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Outcomes of individual participant data will be made available in a de-identified fashion.
IPD Sharing Time Frame
The clinical study report will be available at the conclusion of the study.
IPD Sharing Access Criteria
Requests will be made to the study principal investigator.
Learn more about this trial
Cell-based Therapy for the Treatment of Kidney Disease
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