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

NCT04490486 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 20200575
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

COVID-19; Acute Respiratory Distress Syndrome; Corona Virus Infection

Keywords

Acute Pulmonary Inflammation

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (12)

• Change in inflammatory marker levels

  Baseline, Day 30

• Change in systemic inflammatory marker levels

  Baseline, Day 30

• COVID-19 Viral Load

  Up to 30 Days

• Change in SOFA score

  Baseline, Up to 30 Days

• Change in electrolytes levels

  Baseline, Up to 30 Days

Study Arms (2)

Group 1: (UCMSCs)

EXPERIMENTAL

Participants in this group will receive the 2 intravenous (IV) UCMSCs intervention on day 0 and day 3.

Biological: UCMSCs

Group 2: (Placebo)

PLACEBO COMPARATOR

Participants in this group will receive the placebo, a solution of 1% human serum albumin in Plasmalyte A, on day 0 and day 3.

Other: Placebo

Interventions

UCMSCs BIOLOGICAL

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

Group 1: (UCMSCs)

Placebo OTHER

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

Group 2: (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Joshua M Hare: lead

Related Links

• Interdisciplinary Stem Cell Institute at the University of Miami Miller School website

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Joshua M Hare, MD

  ISCI/University of Miami Miller School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of ISCI, Louis Lemberg Professor of Medicine

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 29, 2020
• Study Start: October 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share