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Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
COVI-MSC
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid-19, long haul, post-acute covid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
  • Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
  • Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
  • Willing to follow contraception guidelines

Exclusion Criteria:

  • Clinically improving pulmonary status over the month prior to screening
  • Undergone a previous stem cell infusion unrelated to this trial
  • Pregnant or breast feeding or planning for either during the study
  • Suspected uncontrolled active bacterial, fungal, viral, or other infection
  • History of a splenectomy, lung transplant or lung lobectomy
  • Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    COVI-MSC 1 vial

    COVI-MSC 2 vials

    Arm Description

    Subjects will receive intravenous infusions of COVI-MSC (one vial, ~18.5 million cells) on Day 0, Day 2, and Day 4.

    Subjects will receive intravenous infusions of COVI-MSC (two vials, ~37 million cells) on Day 0, Day 2, and Day 4.

    Outcomes

    Primary Outcome Measures

    Change in 6-Minute Walk Distance (6MWD) at Day 60
    Change in 6MWD at Day 60

    Secondary Outcome Measures

    Change in 6MWD at Day 30
    Change in 6MWD at Day 30
    Change in Pulmonary Function Tests (PFTs)
    Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO)
    Change in oxygenation
    Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio
    Change in biomarker levels
    Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor

    Full Information

    First Posted
    May 29, 2021
    Last Updated
    September 14, 2021
    Sponsor
    Sorrento Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04909892
    Brief Title
    Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
    Official Title
    A Phase 2a Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Replaced by a different protocol.
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    January 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sorrento Therapeutics, Inc.

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.
    Detailed Description
    This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise. COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid19
    Keywords
    covid-19, long haul, post-acute covid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COVI-MSC 1 vial
    Arm Type
    Experimental
    Arm Description
    Subjects will receive intravenous infusions of COVI-MSC (one vial, ~18.5 million cells) on Day 0, Day 2, and Day 4.
    Arm Title
    COVI-MSC 2 vials
    Arm Type
    Experimental
    Arm Description
    Subjects will receive intravenous infusions of COVI-MSC (two vials, ~37 million cells) on Day 0, Day 2, and Day 4.
    Intervention Type
    Biological
    Intervention Name(s)
    COVI-MSC
    Intervention Description
    COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
    Primary Outcome Measure Information:
    Title
    Change in 6-Minute Walk Distance (6MWD) at Day 60
    Description
    Change in 6MWD at Day 60
    Time Frame
    Baseline to Day 60
    Secondary Outcome Measure Information:
    Title
    Change in 6MWD at Day 30
    Description
    Change in 6MWD at Day 30
    Time Frame
    Baseline to Day 30
    Title
    Change in Pulmonary Function Tests (PFTs)
    Description
    Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO)
    Time Frame
    Baseline to Day 30 and Day 60
    Title
    Change in oxygenation
    Description
    Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio
    Time Frame
    Baseline to Day 30 and Day 60
    Title
    Change in biomarker levels
    Description
    Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor
    Time Frame
    Baseline through Day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test) Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status Willing to follow contraception guidelines Exclusion Criteria: Clinically improving pulmonary status over the month prior to screening Undergone a previous stem cell infusion unrelated to this trial Pregnant or breast feeding or planning for either during the study Suspected uncontrolled active bacterial, fungal, viral, or other infection History of a splenectomy, lung transplant or lung lobectomy Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mike Royal, MD
    Organizational Affiliation
    Sorrento Therapeutics, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

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