NCT02804945

Brief Summary

The goal of this clinical research study is to learn about the safety of giving mesenchymal stem cells (MSCs) to patients who have ARDS. Researchers also want to learn if these cells can help control ARDS when given with drugs that are routinely used to treat ARDS. In this study, participants will receive 1 infusion of MSCs. This is an investigational study. MSC infusions for the treatment of ARDS is investigational. Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 24, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2019

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

2.3 years

First QC Date

June 15, 2016

Last Update Submit

April 8, 2020

Conditions

Blood And Marrow TransplantationAdult Respiratory Distress Syndrome

Keywords

Blood And Marrow TransplantationAdult Respiratory Distress SyndromeARDSAllogeneic human mesenchymal stem cellshMSCsPlaceboPlasma-Lyte A solutionStandard of CareRecent onset pulmonary toxicity

Outcome Measures

Primary Outcomes (1)

  • Adverse Events of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)

    Adverse Events determined by CTCAE version 4.

    30 days

Secondary Outcomes (2)

  • Clinical Improvement of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)

    Baseline, 7 days and 30 days

  • Improvement in PF or S/F Ratio of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)

    Baseline, 7 days and 30 days

Study Arms (1)

Mesenchymal Stem Cells

EXPERIMENTAL

Participants receive Mesenchymal Stem Cells (MSCs) for adult respiratory distress syndrome (ARDS). Participants receive a maximum dose of 3 x 10\^6 cell/Kg by vein one time on Day 1.

Biological: Mesenchymal Stem Cells (MSCs)

Interventions

Mesenchymal Stem Cells (MSCs)BIOLOGICAL

Participants receive a maximum dose of 3 x 10\^6 cell/Kg by vein one time on Day 1.

Mesenchymal Stem Cells

Eligibility Criteria

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

You may qualify if:

  • ARDS characterized by hypoxemia and bilateral radiographic opacities not fully explained by cardiac failure or fluid overload as judged by the treating physician using all available data. Moderate ARDS includes patients with malignancies with the previous presentation and a P/F ratio \</= 200 or SF ratio of \</= 214. The duration of the hypoxemia criterion and the radiograph criterion must be within 10 days of the time of enrollment.
  • Patients age \>/=18 years.
  • Treated with appropriate maximal medical therapy for pulmonary toxicity.
  • Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
  • Patient or legally appropriate proxy must be able to understand study instructions and sign consent.

You may not qualify if:

  • Unstable ventricular tachycardia or fibrillation.
  • Moribund patients not expected to survive up to 48 hours.
  • Patients with ARDS resulting from trauma.
  • Patients with documented deep venous thrombosis or pulmonary embolism within the past 3 months.
  • Patients with severe chronic liver disease (Childs-Pugh score \> 10).
  • Patients with previous solid organ transplant.
  • Pregnant and/or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Amanda L. Olson, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

February 24, 2017

Primary Completion

June 13, 2019

Study Completion

June 13, 2019

Last Updated

April 10, 2020

Record last verified: 2020-04

Locations

US(1)