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NCT04187625 Clinical Trial

Cell-based Therapy for the Treatment of Kidney Disease

Kidney Diseases Clinical Trial

— CTKD  

Official title:
Cell-based Therapy for the Treatment of Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04187625
Other study ID # 2019P003586
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date January 1, 2023
Est. completion date May 1, 2025

Study information
Verified date July 2022
Source Brigham and Women's Hospital
Contact Andrew M Siedlecki, MD
Phone 314-809-2879
Email asiedlecki@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date May 1, 2025
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Enrolled patients will have endothelial progenitor cells previously acquired. Exclusion Criteria: - Patients without previously acquired endothelial progenitor cells will be excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• endothelial progenitor cell
Kidney-derived endothelial progenitor cells will be delivered percutaneously to the kidney blood supply.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of progenitor cell delivery Serum creatinine will be measured after cell delivery 180 days
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