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Trial record 1 of 3 for:    stem cell | long covid
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Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04909892
Recruitment Status : Withdrawn (Replaced by a different protocol.)
First Posted : June 2, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: COVI-MSC Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022


Arm Intervention/treatment
Experimental: COVI-MSC 1 vial
Subjects will receive intravenous infusions of COVI-MSC (one vial, ~18.5 million cells) on Day 0, Day 2, and Day 4.
Biological: COVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

Experimental: COVI-MSC 2 vials
Subjects will receive intravenous infusions of COVI-MSC (two vials, ~37 million cells) on Day 0, Day 2, and Day 4.
Biological: COVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells




Primary Outcome Measures :
  1. Change in 6-Minute Walk Distance (6MWD) at Day 60 [ Time Frame: Baseline to Day 60 ]
    Change in 6MWD at Day 60


Secondary Outcome Measures :
  1. Change in 6MWD at Day 30 [ Time Frame: Baseline to Day 30 ]
    Change in 6MWD at Day 30

  2. Change in Pulmonary Function Tests (PFTs) [ Time Frame: Baseline to Day 30 and Day 60 ]
    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)

  3. Change in oxygenation [ Time Frame: Baseline to Day 30 and Day 60 ]
    Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio

  4. Change in biomarker levels [ Time Frame: Baseline through Day 30 ]
    Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor



Information from the National Library of Medicine

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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:

  • 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)

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): NCT04909892


Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04909892    
Other Study ID Numbers: MSC-PLH-201
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorrento Therapeutics, Inc.:
covid-19
long haul
post-acute covid
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases