A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19

July 7, 2022 updated by: Stemedica Cell Technologies, Inc.

A Phase II, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients With Moderate to Severe ARDS Due to COVID-19

This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. The study will enroll up to 40 Patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (LRS) plus standard treatment. On the treatment (Day 0) Cohort 1 will receive a single IV dose of hMSCs Cohort 2 will receive Lactated Ringer's Solution. A second dose of MSCs or LRS will be given to Cohort 1 or Cohort 2, respectively on Day 3 after the first dose. Patients who discontinue the study before Month 1 for reasons other than adverse events will be replaced.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
        • Contact:
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Providence Saint John's Health Center - Saint John's Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Laboratory-confirmed diagnosis of COVID-19 <= 14 days prior to randomization

  • The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin Definition:

    1. Bilateral chest radiograph infiltrates.
    2. PaO2:FiO2 ratio of less than 200.
    3. Absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema)
  • Absence of moribund state that would indicate imminent demise and poor chance of survival.

Exclusion Criteria:

  • Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded.
  • Breastfeeding mothers
  • Patients on ECMO
  • Receiving concurrent treatment with an investigational agent in a clinical trial.
  • Exception: Use of COVID-19 convalescent plasma is permitted.
  • More than 72hrs on mechanical ventilation before randomization
  • Receiving concurrent investigational vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hMSCs
hMSCs will be given via IV administration.
Biological: hMSC
IV administration
Other Names:
  • allogeneic mesenchymal bone marrow cells
Placebo Comparator: Lactated Ringer's Solution
Lactated Ringer's Solution will be given via IV administration.
Biological: hMSC
IV administration
Other Names:
  • allogeneic mesenchymal bone marrow cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 14 days post treatment
Number of patients alive at day 14 post treatment
14 days post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 9 months
Frequency of adverse events in patients treated with hMSCs and Lactate Ringer's solutions will be compared.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stemedica Cell Technologies, Inc.

Collaborators

bioRASI, LLC

Investigators

  • Study Director: Lev Verkh, PhD/MS, Stemedica Cell Technologies, Inc.
  • Principal Investigator: Santosh Kesari, MD, Providence Saint John's Health Center - Saint John's Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEM-107-COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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