NCT04494386

Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS

Phase 1/2a Study of Umbilical Cord Lining Stem Cells (ULSC) in Patients With ARDS Due to COVID-19

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Restem, LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The Phase 1, open-label, non-controlled trial in this study will investigate the safety of intravenous (IV) infusion of ULSC in a total of 20 patients with COVID-19-related ARDS that will include patients that are not intubated and not on a ventilator (NV) and patients that are intubated and on a ventilator (V) for respiratory support. Separate cohorts of each group (NV and V) will receive either a single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval). The Phase 2a randomized and placebo-controlled trial in this study will investigate the potential efficacy of IV infusion of ULSC in a total of 40 patients with COVID-19-related ARDS that will all be EITHER NV or V; the determination of that eligibility criterion and the ULSC dosing regimen will be based on Phase 1 data of safety and tolerability. Phase 2a will evaluate EITHER single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval). The randomization will be 3:1 with 30 patients receiving investigational product (ULSC) and 10 patients receiving placebo (carrier control).

Conditions

• Covid19
• Corona Virus Infection
• SARS-CoV Infection
• ARDS
• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	Umbilical Cord Lining Stem Cells (ULSC)	IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection
OTHER	Placebo (carrier control)	IV infusion of carrier control consisting of sterile saline for injection

Timeline

• Start date: 2020-12-23
• Primary completion: 2023-05-12
• Completion: 2023-05-12
• First posted: 2020-07-31
• Last updated: 2024-04-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study