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hCT-MSCs for COVID19 ARDS

NCT04399889 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-12-20

Study results available
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Summary

This is a 50 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal cells (hCT-MSC) as an investigational agent, under U.S. INDs 19968 (Duke) and 19937 (U Miami) to patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection (COVID-ARDS). The first 10 consecutive patients will receive investigational MSCs manufactured by Duke. In the second phase of the study, 40 additional patients will be randomized to receive placebo or investigational MSCs manufactured by Duke or University of Miami.

Patients will be eligible for infusion of 3 daily consecutive doses of hCT-MSC or placebo if they have a confirmed diagnosis of COVID-19 and meet clinical and radiographic criteria for ARDS.

Results from the first 10 patients will be compared with concurrent outcomes utilizing standard of care treatments in participating hospitals and in published reports in the medical literature. Results from the additional 40 patients will be combined with the first 10 and analyzed. The trial is relying on focused eligibility of the participants (patients with ARDS), single cohort with short trial time (4 weeks), and simple assessment of clinical outcome (survival, improvement of ARDS). This is a sequential design in the sense that after the first 10 patients are evaluated a decision will be made by the PIs and the Data Safety Monitoring Board whether to proceed with the exploratory randomized portion of the study.

Conditions

  • COVID
  • Corona Virus Infection
  • COVID19

Interventions

BIOLOGICAL

Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.

Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.

OTHER

Placebo

Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.

Sponsors & Collaborators

  • The Marcus Foundation

    collaborator OTHER

  • Joanne Kurtzberg, MD

    lead OTHER

Principal Investigators

  • Joanne Kurtzberg, MD · Duke Health

  • Lingye Chen, MD · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2022-02-16
Completion
2022-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04399889 on ClinicalTrials.gov