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Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells

NCT04626583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-12-16

No results posted yet for this study

Summary

This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of locally delivered allogeneic mesenchymal stromal cells (MSC) for promoting corneal repair. The study will be conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicago. The study will use digital conjunctival and corneal photography and corneal Scheimpflug Imaging, densitometry, and pachymetry for assessment of safety and corneal wound healing.

Conditions

  • Mesenchymal Stromal Cells
  • Cornea
  • Safety
  • Corneal Defect

Interventions

BIOLOGICAL

Allogeneic MSC

Subconjunctival Injection of Allogeneic Mesenchymal Stromal Cells

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Ali R Djalilian, MD · University of Illinois Chicago

  • Charlotte E Joslin, OD, PhD · University of Illinois Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2023-04-21
Completion
2023-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04626583 on ClinicalTrials.gov