NCT05491681

Brief Summary

Allogeneic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as they are supported by preclinical and clinical data for potential to provide a safe and effective treatment for patients with acute respiratory distress.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2026

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
3.4 years until next milestone

Study Start

First participant enrolled

January 4, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

August 5, 2022

Last Update Submit

January 4, 2026

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

  • Number of product related adverse events through the duration of the study.

    Number of product related adverse events through the duration of the study.

    3 months

Secondary Outcomes (1)

  • Secondary Endpoint

    12 months

Study Arms (3)

Low dose

EXPERIMENTAL

Experimental: Cohort 1 Low dose, 20M cells, 3 patients

Biological: intravenous delivery of allogeneic bone marrow-derived MSCs

Medium dose

EXPERIMENTAL

Experimental: Cohort 2 Med dose, 100M cells, 3 patients

Biological: intravenous delivery of allogeneic bone marrow-derived MSCs

High dose

EXPERIMENTAL

Experimental: Cohort 3 High dose, 200M cells, 3 patients

Biological: intravenous delivery of allogeneic bone marrow-derived MSCs

Interventions

intravenous delivery of allogeneic bone marrow-derived MSCsBIOLOGICAL

MSCs

Also known as: allogeneic NK1R+MSC
High doseLow doseMedium dose

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient \> 18 years and ≤ 80 at age at consent
  • Patient must have:
  • Have a laboratory-confirmed COVID-19 diagnosis (nucleic acid-based assay (e.g., RTPCR) to establish the diagnosis of SARS-CoV-2 infection), who recovered from moderate to severe COVID-19 associated ARDS, as determined by Berlin Criteria and been weaned off the ventilator support."
  • Meet the criteria for mild and moderate COVID-19 as described in COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry (Feb 2021).
  • Recovery from moderate to severe ARDS, diagnosed based on Berlin Criteria, within past 7 days.
  • PaO2/FiO2 \> 100 to \<200 mmHg with PEEP\>5cm H2O
  • Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23
  • Understands and agrees to comply with planned study procedures
  • Available for clinical follow-up for duration of the treatment and follow-up period
  • Woman of childbearing potential must have a negative pregnancy test at admission or within 24 hours before starting treatment
  • Agree not to become pregnant during treatment and for 1 months after receiving treatment
  • Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period

You may not qualify if:

  • Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen (chronic obstructive pulmonary disease or pulmonary fibrosis)
  • Be an organ transplant recipient
  • ALT/AST ≥ 5 times the upper limit of normal
  • BMI \> 40
  • Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR \<30)
  • Anticipated transfer to another hospital that is not a study site within 72 hours
  • Shock or on ECMO
  • Pregnant or nursing
  • On a ventilator at the time of enrollment
  • Have received high dose corticosteroids at doses \>20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry.
  • Have been diagnosed with cancer
  • Demonstrated inability to comply with the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Dose finding study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 8, 2022

Study Start

January 4, 2026

Primary Completion

January 4, 2026

Study Completion

January 4, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share