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CTKD: Cell-based Therapy for the Treatment of Kidney Disease

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04187625
Collaborator
(none)
10
Enrollment
1
Arm
28
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: endothelial progenitor cell
 Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open label single arm studyOpen label single arm study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cell-based Therapy for the Treatment of Kidney Disease
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Safety of progenitor cell delivery [180 days]

    Serum creatinine will be measured after cell delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Enrolled patients will have endothelial progenitor cells previously acquired.
Exclusion Criteria:
  • Patients without previously acquired endothelial progenitor cells will be excluded.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

  • Principal Investigator: Andrew M Siedlecki, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrew Michael Siedlecki, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04187625
Other Study ID Numbers:
  • 2019P003586
First Posted:
Dec 5, 2019
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases

Study Results

No Results Posted as of Jul 26, 2022