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COVID-19Phase 1COVID-19NCT04490486

Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19

A Phase 1 study testing UCMSCs in people with COVID-19 and Acute Respiratory Distress Syndrome, run by Joshua M Hare.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
UCMSCs
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Oct 2022to 1 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent
  • Male or female subjects age > 18 years at the time of signing the Informed Consent Form.
  • COVID-19 positive according to diagnosis (evaluated by reverse transcription (RT)-polymerase chain reaction (PCR) test confirming infection with severe acute respiratory syndrome coronavirus and clinical management of COVID-19 criteria (refer to appendix B)
  • Individuals with moderate to severe COVID-19 symptoms.
  • Moderate:
  • Patients with moderate disease are symptomatic (e.g. fever, cough, headache, myalgia, sore throat, nasal congestion, nausea, vomiting, diarrhea, fatigue, anosmia, or dysgeusia) and have abnormal chest imaging or some degree of hypoxia requiring supplemental oxygen but not intubation.
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  • Moderate-severe:
  • The Moderately Severe disease category includes patients who are symptomatic (as described above), have abnormal chest imaging, but also have worsening hypoxia compatible with mild acute respiratory distress syndrome (ARDS) (Partial Pressure of Oxygen (PaO2)/Fraction of Inspired Oxygen (FiO2) </= 300 but > 200) - Berlin criteria; but do not yet require intubation .
  • Adequate venous access
  • For female patients only, willingness to use FDA-recommended birth control until 6 months post treatment.
  • Must agree to comply with all study requirements and be willing to complete all study visits.
  • Need in-patient admission

Who cannot join

  • PaO2/FiO2 </= 200
  • Anticipated intubation within 24h
  • Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening and prior to infusion.
  • Inability to perform any of the assessments required for endpoint analysis.
  • Subjects that are unsuitable with the study requirements .
  • Active listing (or expected future listing) for transplant of any organ.
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  • Have known allergies to penicillin or streptomycin.
  • Be a solid organ transplant recipient. This does not include prior cell-based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
  • Have a history of organ or cell transplant rejection
  • Has a history of an adverse response to cell-based therapy
  • Have presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 1 year.
  • History of active drug abuse (illegal "street" drugs except marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months
  • Be serum positive for HIV, Surface antigen of Hepatitis B virus (HBsAg) or Viremic hepatitis C.
  • Severe hepatic impairment (defined as liver cirrhosis Child stage B or C);
  • Stage 4 chronic kidney disease or currently receiving chronic dialysis;
  • Advanced cardiac (eg, severe heart failure [New York Heart Association (NYHA) III-IV]) or pulmonary diseases;
  • Has uncontrolled hypertension as defined by BP systolic above 180 and diastolic above 110 which, in the Investigator's judgment, would not make participation appropriate;
  • Known allergy or hypersensitivity to stem cell infusions or its components;
  • Current enrollment in an investigational drug or participation in such a study within 15 days of entry into this study;
  • Moderate to severe liver failure (Childs-Pugh Score > 10) Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) > 5 times the upper limit of normal;
  • Congenital prolonged QT syndrome;
  • Current QT corrected (QTc) above 490 msec. If patient has Q, R and S waves (QRS) interval greater or equal to 120 msec, then the QT/QTc will be normalized to a QRS interval of 110 msec. (For instance, if the patient has a bundle branch block with QRS of 140 msec and QT/QTc of 470 msec, the normalized QTc will be 470;
  • Subjects taking drugs that could affect the QT interval (e.g. procainamide, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol, cimetidine, dronedarone, dofetilide, levofloxacin, ciprofloxacin, moxifloxacin);
  • Anticipated transfer to another hospital which is not a study site within 72 hours;
  • Coagulopathy (Platelets less than 80,000, or Prothrombin Time (PT)/Partial Thromboplastin time (PTT) twice normal range without systemic anticoagulation;
  • Greater than 24h since first meeting ARDS criteria (Berlin definition) or 72h of ICU admission;
  • Subjects who are legally detained in an official institution;
  • A previous MSC infusion in last 30 days not related to this trial;
  • History of Pulmonary Hypertension (WHO Class III/IV);
  • Unstable arrhythmia or uncontrolled hypertension not responding to best ICU treatment;
  • Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO);
  • Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%;
  • Moribund patient not expected to survive > 24 hours;
  • The investigator believes that participating in the trial is not in the best interest of the patient, or the investigator considers patient unsuitable for enrollment (such as unpredictable risks or subject compliance issues)

About this study

Official title: Phase I, Randomized, Double Blinded, Placebo Control Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 With Moderate to Severe Symptoms

The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms

Being tested
UCMSCs, Placebo
Keywords
Acute Pulmonary Inflammation
Medical subject headings
COVID-19, Respiratory Distress Syndrome, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UCMSCsBiological

    100 x 106 (100 million) UCMSCs delivered via peripheral intravenous infusion.

  • PlaceboOther

    Placebo, a solution of 1% human serum albumin in Plasmalyte A, delivered via peripheral intravenous infusion

Study groups in NCT04490486
Study groupRoleWhat they receive
Group 1: (UCMSCs)ExperimentalParticipants in this group will receive the 2 intravenous (IV) UCMSCs intervention on day 0 and day 3.
Receives: Biological: UCMSCs
Group 2: (Placebo)Placebo comparatorParticipants in this group will receive the placebo, a solution of 1% human serum albumin in Plasmalyte A, on day 0 and day 3.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of participants with treatment related Serious Adverse Events (SAE)

    Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.

    Measured: 12 months

Secondary outcomes (12)

  1. Change in inflammatory marker levels

    Change in serum inflammatory marker levels including Interleukin (IL) IL-6, IL-2, Tumor Necrosis Factor Alpha (TNF-a) and procalcitonin will be evaluated in ng/L.

    Measured: Baseline, Day 30

  2. Change in systemic inflammatory marker levels

    Change in serum systemic inflammatory marker levels including D-dimer, high sensitivity C-reactive protein (hsCRP) and ferritin will be evaluated in mg/L.

    Measured: Baseline, Day 30

  3. COVID-19 Viral Load

    Assessed using blood samples or nose/throat swabs.

    Measured: Up to 30 Days

  4. Change in SOFA score

    Sequential Organ Failure Assessment (SOFA) will be used to assess organ failure including the cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs. SOFA score ranges from 0-24 with the higher score indicating worse outcomes.

    Measured: Baseline, Up to 30 Days

  5. Change in electrolytes levels

    Sodium, Potassium, Chloride and Carbon Dioxide (CO2) will be evaluated in mmol/L. Changes from baseline to Day 30 will be compared between groups.

    Measured: Baseline, Up to 30 Days

  6. Change in LDH levels

    Serum Lactate Dehydrogenase (LDH) levels assessed in U/L. Changes in LDH from baseline to Day 30 will be compared between groups.

    Measured: Baseline, Up to 30 Days

  7. Number of subjects discharged from the ICU

    ICU monitoring status will be reported as the number of subjects discharged from the ICU within 7 days.

    Measured: Up to 7 Days

  8. Percentage of participants with less requirement for vasoactive agents

    Percentage of participants requiring less use of vasoactive agents will be reported.

    Measured: Up to 30 Days

  9. Rate of Mortality

    Percentage of participant deaths throughout the study period.

    Measured: Up to 30 Days

  10. Percentage of participants with changes in immune marker expression

    The percentage of participants with changes in serum immune marker levels including Cluster of Differentiation (CD) CD 4+ and CD 8+, as evaluated by treating physician will be reported.

    Measured: Up to 30 Days

  11. Percentage of participants with changes in radiologic findings

    Percentage of participants with changes in their chest imaging such as ground-glass opacity, local patch shadowing, bilateral patch shadowing and interstitial abnormalities will be reported. Imaging will be assessed by treating physician using chest radiography or chest Computed Tomography (CT).

    Measured: Up to 30 Days

  12. Percentage of participants with less pneumonia symptoms

    Percentage of participants showing less pneumonia symptoms will be reported as evaluated by treating physician using chest radiography or chest CT.

    Measured: Up to 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2020
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Why it stopped: Not Funded

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04490486
Sponsor's protocol ID
20200575
Acronym
COVID-19
Status last verified
May 2022
First submitted
27 Jul 2020
Last updated
12 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UCMSCs in people with COVID-19 and Acute Respiratory Distress Syndrome, run by Joshua M Hare.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of participants with treatment related Serious Adverse Events (SAE) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04490486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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