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

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Restem, LLC.

Trial Summary

What is the purpose of this trial?

ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I have tested positive for COVID-19 with a PCR test.

My ARDS is classified as mild, moderate, or severe based on my oxygen levels.

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Exclusion Criteria

You are allergic to any of the ingredients in the study product, or you have had a bad reaction to dimethyl sulfoxide (DMSO) in the past.

I am not pregnant or breastfeeding, and if capable of becoming pregnant, I agree to use contraception.

I was on dialysis for kidney failure before getting COVID-19.

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Treatment Details

Interventions

Umbilical Cord Lining Stem Cells (ULSC) (Mesenchymal Stem Cells)

Trial OverviewThe 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.

Participant Groups

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.