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Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS

NCT04494386 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-04-09

No results posted yet for this study

Summary

ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.

Conditions

  • Covid19
  • Corona Virus Infection
  • SARS-CoV Infection
  • ARDS
  • Coronavirus

Interventions

BIOLOGICAL

Umbilical Cord Lining Stem Cells (ULSC)

IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection

OTHER

Placebo (carrier control)

IV infusion of carrier control consisting of sterile saline for injection

Sponsors & Collaborators

  • Restem, LLC.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2023-05-12
Completion
2023-05-12
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 NCT04494386 on ClinicalTrials.gov