NCT04187625

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2023

Typical duration for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

December 3, 2019

Last Update Submit

July 25, 2022

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • Safety of progenitor cell delivery

    Serum creatinine will be measured after cell delivery

    180 days

Study Arms (1)

Intervention

EXPERIMENTAL

Patients will be given autologous endothelial progenitor cells

Biological: endothelial progenitor cell

Interventions

endothelial progenitor cellBIOLOGICAL

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

Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled patients will have endothelial progenitor cells previously acquired.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Andrew M Siedlecki, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew M Siedlecki, MD

CONTACT

314-809-2879asiedlecki@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label single arm study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 5, 2019

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

May 1, 2025

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Outcomes of individual participant data will be made available in a de-identified fashion.

Shared Documents
CSR
Time Frame
The clinical study report will be available at the conclusion of the study.
Access Criteria
Requests will be made to the study principal investigator.