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Cell-based Therapy for the Treatment of Kidney Disease

NCT ID: NCT04187625

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label single arm study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Patients will be given autologous endothelial progenitor cells

Group Type EXPERIMENTAL

endothelial progenitor cell

Intervention Type BIOLOGICAL

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

Interventions

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endothelial progenitor cell

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled patients will have endothelial progenitor cells previously acquired.

Exclusion Criteria

* Patients without previously acquired endothelial progenitor cells will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Andrew Michael Siedlecki

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew M Siedlecki, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Central Contacts

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Andrew M Siedlecki, MD

Role: CONTACT

[email protected]
314-809-2879

Other Identifiers

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2019P003586

Identifier Type: -

Identifier Source: org_study_id

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