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Cord Blood-Derived Mesenchymal Stem Cells for the Treatment of COVID-19 Related Acute Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT04565665
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : April 20, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.

Condition or disease Intervention/treatment Phase
COVID-19 Infection COVID-19-Associated Acute Respiratory Distress Syndrome Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Symptomatic COVID-19 Infection Laboratory-Confirmed Other: Best Practice Biological: Mesenchymal Stem Cell Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To assess the safety of administering cord blood derived mesenchymal stem cell (CB-MSC) infusions for treatment of COVID-19 acute respiratory distress syndrome (ARDS).

SECONDARY OBJECTIVES:

I. In the group of patients who present intubated on ventilator support, assess the proportion that are able to be successfully extubated.

II. In the group of patients who present requiring supplemental oxygen but otherwise breathing without assistance, assess the rate of progression to intubation.

III. Estimate the survival rate at day 30 post treatment separately by group.

IV. Determine the treatment effect on clinical parameters, oxygenation and respiratory parameters:

IVa. Resolution of fever. IVb. Changes in oxygen demand (increased oxygen saturation at similar fraction of inspired oxygen [FiO2] or decreased FiO2 requirement).

IVc. Progression to mechanical ventilation. IVd. Length of mechanical ventilation. IVe. Decrease in positive end-expiratory pressure (PEEP) in intubated patients. IVf. Decrease in FiO2 in intubated patients.

V. Determine the treatment effect on laboratory markers:

Va. Complete blood count. Vb. C-reactive protein (CRP). Vc. Ferritin. Vd. D dimer. Ve. Procalcitonin. Vf. Cytokine levels. VI. Estimate hospitalization and intensive care unit (ICU) stay. VII. Report on study related adverse events.

OUTLINE:

Currently not shipping cells outside of MD Anderson Cancer Center in Houston.

PILOT STUDY: Patients receive MSCs intravenously (IV) over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.

PHASE II STUDY: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive MSCs IV over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.

ARM II: Patients receive standard of care.

After completion of study treatment, patients are followed up at days 7, 14, 30, 60, and months 6 and 12.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment Acute Respiratory Distress Syndrome
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021


Arm Intervention/treatment
Experimental: Phase II Arm I (mesenchymal stem cells)
Patients receive MSCs as in the Pilot study.
Biological: Mesenchymal Stem Cell
Given IV
Other Names:
  • Mesenchymal Progenitor Cell
  • MPC

Active Comparator: Phase II Arm II (standard of care)
Patients receive standard of care.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Experimental: Pilot study (mesenchymal stem cells)
Patients receive MSCs IV over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.
Biological: Mesenchymal Stem Cell
Given IV
Other Names:
  • Mesenchymal Progenitor Cell
  • MPC




Primary Outcome Measures :
  1. Incidence of composite serious adverse events (Phase I) [ Time Frame: Within 30 days of the first mesenchymal stem cell (MSC) infusion ]
    Serious adverse events with be comprised of grade 3 or 4 graft versus host disease or death and will be estimated and reported overall and by group, along with 95% confidence intervals.

  2. Patients alive without grade 3, 4 infusional toxicity (Phase II) [ Time Frame: At day 30 post MSC infusion ]
  3. Patients alive with grade 3 or 4 infusional toxicity (Phase II) [ Time Frame: At day 30 post MSC infusion ]
  4. Patients not alive (Phase II) [ Time Frame: At day 30 post MSC infusion ]

Secondary Outcome Measures :
  1. Proportion of successfully extubated patients who present intubated on ventilator support (Phase I) [ Time Frame: Up to day 30 post MSC infusion ]
    Will be estimated and reported with 95% confidence intervals.

  2. Rate of successful progression to intubation in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I) [ Time Frame: Up to day 30 post MSC infusion ]
    Will be estimated and reported with 95% confidence intervals.

  3. Overall survival rate (Phase I) [ Time Frame: At day 30 post MSC infusion ]
    Will be estimated and reported with 95% confidence intervals.

  4. Survival rate in patients who present intubated on ventilator support (Phase I) [ Time Frame: At day 30 post MSC infusion ]
    Will be estimated and reported with 95% confidence intervals.

  5. Survival rate in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I) [ Time Frame: At day 30 post MSC infusion ]
    Will be estimated and reported with 95% confidence intervals.

  6. Clinical parameters (Phase I) [ Time Frame: Up to day 30 post MSC infusion ]
    The effect of MSCs on clinical parameters will be assessed. Continuous clinical parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables.

  7. Oxygenation parameters (Phase I) [ Time Frame: Up to day 30 post MSC infusion ]
    The effect of MSCs on oxygenation parameters will be assessed. Continuous oxygenation parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables.

  8. Respiratory parameters (Phase I) [ Time Frame: Up to day 30 post MSC infusion ]
    The effect of MSCs on respiratory parameters will be assessed. Continuous respiratory parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables.

  9. Laboratory markers (Phase I) [ Time Frame: Up to day 30 post MSC infusion ]
    The effect of MSCs on laboratory markers will be assessed. Continuous laboratory parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables.

  10. Hospitalization stay (Phase I) [ Time Frame: Up to day 30 post MSC infusion ]
  11. Intensive care unit stay (Phase I) [ Time Frame: Up to day 30 post MSC infusion ]
  12. Incidence of infusion-related adverse events (Phase I) [ Time Frame: Up to day 30 post MSC infusion ]
    All grades of infusion-related adverse events will be summarized by grade and type.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients with moderate to severe ARDS per Berlin criteria secondary to COVID-19. Moderate to severe is defined in appendix as the following: moderate partial pressure of arterial oxygen (PaO2)/FiO2 of 100-200 mm Hg, severe PaO2/FiO2 of less than 100 mm Hg
  • 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 authorized representative consent
  • Because of the nature of COVID-19, patients enrolled on this study with COVID-19 associated ARDS may have been previously enrolled in other Investigational New Drug (IND) trials for their cancer diagnosis or COVID-19. These enrollments will not exclude them from enrollment to this study

Exclusion Criteria:

  • Moribund patients not expected to survive up to 48 hours
  • Patients with severe chronic liver disease (Childs-Pugh score > 10)
  • Pregnant and/or lactating women
  • Patients on extracorporeal membrane oxygenation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565665


Contacts
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Contact: Bethany Overman 713-745-4567 BJSpears@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Bethany J. Overman    713-745-4567    BJSpears@mdanderson.org   
Principal Investigator: Amanda Olson         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amanda Olson M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04565665    
Other Study ID Numbers: 2020-0365
NCI-2020-06741 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0365 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Laboratory Infection
Neoplasms
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Disease Attributes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Occupational Diseases