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Mesenchymal Stem Cells

Stem Cell Therapy for COVID-19 ARDS (ULSC Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Restem, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of the presence of the COVID-19 agent with confirmation of COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) or equivalent test
Patient with diagnosis of COVID-related ARDS, classified as either not requiring mechanical ventilation (NV) or requiring mechanical ventilation (V)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 2 months, 3 months, 6 months, and 12 months
Awards & highlights

ULSC Trial Summary

This trial will test the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC) in patients with acute respiratory distress syndrome (ARDS) due to COVID-19.

Who is the study for?
Adults over 18 with confirmed COVID-19 and acute respiratory distress syndrome (ARDS), not on dialysis, without active cancer or a history of cancer in the past year, and not pregnant. Participants must have worsened within the last 72 hours despite standard care.Check my eligibility
What is being tested?
The trial is testing Umbilical Cord Lining Stem Cells (ULSC) against a placebo to see if they're safe and can help hospitalized COVID-19 patients with ARDS. It's given intravenously in two phases to measure its effects.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, allergic responses due to hypersensitivity to components like DMSO, and other unforeseen immune reactions.

ULSC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tested positive for COVID-19 with a PCR test.
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I have COVID-related ARDS and am either on a ventilator or not.

ULSC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 2 months, 3 months, 6 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 2 months, 3 months, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Dose Limiting Toxicity (DLT)
Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE)
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Secondary outcome measures
Change in Urinalysis (UA) from baseline
Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio
Changes in Complete Blood Count (CBC) with differential from baseline
+7 more

ULSC Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ULSC in Phase 2a RandomizedExperimental Treatment1 Intervention
Intravenous (IV) infusion of ULSC in 30 patients with COVID-19 ARDS: In Phase 2a, 30 patients assigned ULSC will receive either a single dose (one infusion) or repeat dose regimen (two infusions separated by 48-hour interval). The ULSC dosing regimen will be chosen based on Phase 1 data of safety and tolerability.
Group II: ULSC in Phase 1 Open LabelExperimental Treatment1 Intervention
Intravenous (IV) infusion of ULSC in 20 patients with COVID-19 ARDS: In Phase 1, two separate cohorts per group will receive either a single dose (one infusion) or repeat dose regimen (two infusions separated by 48-hour interval). The first cohort enrolled will receive the single dose; the next cohort enrolled will be administered the repeat dose regimen.
Group III: Placebo in Phase 2a RandomizedPlacebo Group1 Intervention
Intravenous (IV) infusion of carrier control in 10 patients with COVID-19 ARDS: In Phase 2a, 10 patients assigned Placebo will receive either single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval) of carrier control; the dosing regimen will correspond to that of the experimental arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Umbilical Cord Lining Stem Cells (ULSC)
2020
Completed Phase 2
~20

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Who is running the clinical trial?

Restem, LLC.Lead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
~4 spots leftby Jun 2025
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