Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair

NCT04896567 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: awaiting IRB approval
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.

Conditions

Kidney Diseases; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Cell growth

  Tissue will be isolated and cell viability will be documented by rate of colony growth over one week per patient enrolled.

  1 week

Secondary Outcomes (1)

• Kidney disease progression

  3 years

Study Arms (1)

Intervention

EXPERIMENTAL

Patients will have kidney biopsy designated for cell isolation and culture.

Diagnostic Test: Cell isolation

Interventions

Cell isolation DIAGNOSTIC_TEST

Tissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells.

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only patients who have a clinical indication for kidney biopsy will be considered.
• All subjects will be at least 18 years of age and may be of any gender.
• Patients undergoing a native or kidney transplant biopsy will be considered.

You may not qualify if:

• Patients not undergoing a kidney biopsy will be excluded.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Cell Separation

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Consecutive patients will be consented to obtain kidney biopsy material.

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: May 21, 2021
• Study Start: January 21, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: August 3, 2022

Record last verified: 2022-07

Locations

US (1)