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

• ClinicalTrials.gov Identifier: NCT04780685
• Recruitment Status: Recruiting
• First Posted: March 3, 2021
• Last Update Posted: July 8, 2022
• Sponsor: Stemedica Cell Technologies, Inc.
• Collaborator: bioRASI, LLC
• Information provided by (Responsible Party): Stemedica Cell Technologies, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Covid19	Biological: hMSC	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: This is double-blind study
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: March 20, 2021
• Estimated Primary Completion Date: September 30, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: hMSCs; hMSCs will be given via IV administration.	Biological: hMSC; IV administration; Other Name: 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 Name: allogeneic mesenchymal bone marrow cells

Outcome Measures

Primary Outcome Measures :

1. Survival [ Time Frame: 14 days post treatment ]
   Number of patients alive at day 14 post treatment

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Lev Verkh, PhD/MS; 8586580910; lverkh@stemedica.com

Locations

United States, California

Providence Medical Foundation; Recruiting

Fullerton, California, United States, 92835

Contact: Linda Gozar, MPH 714-992-3000 ext 4332 Linda.Gozar@stjoe.org

Principal Investigator: David Park, MD

Providence Saint John's Health Center - Saint John's Cancer Institute; Recruiting

Santa Monica, California, United States, 90404

Contact: Hotline 310-582-7448 neuro.research@providence.org

Principal Investigator: Santosh Kesari, MD

Sponsors and Collaborators

Stemedica Cell Technologies, Inc.

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

More Information

• Responsible Party: Stemedica Cell Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT04780685
• Other Study ID Numbers: STEM-107-COVID-19
• First Posted: March 3, 2021
• Last Update Posted: July 8, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases