Cell-based Therapy for the Treatment of Kidney Disease (CTKD)

July 25, 2022 updated by: Andrew Michael Siedlecki, Brigham and Women's Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Enrolled patients will have endothelial progenitor cells previously acquired.

Exclusion Criteria:

  • Patients without previously acquired endothelial progenitor cells will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Patients will be given autologous endothelial progenitor cells
Biological: endothelial progenitor cell
Kidney-derived endothelial progenitor cells will be delivered percutaneously to the kidney blood supply.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of progenitor cell delivery
Time Frame: 180 days
Serum creatinine will be measured after cell delivery
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P003586

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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