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Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis

NCT03058068 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-05-13

No results posted yet for this study

Summary

A Safety Run-In will be followed by a Double-Blinded Randomized Phase. All subjects shall meet the inclusion/exclusion criteria, and will be evaluated prior to the scheduled infusion to establish baseline.

There will be 3 subjects in the safety run-in phase and 15 subjects in the double-blinded phase.

Conditions

Interventions

BIOLOGICAL

Allo-hMSCs

1 peripheral intravenous infusion of allogeneic human mesenchymal stem cells (hMSCs)

BIOLOGICAL

Placebo

1 peripheral intravenous infusion

Sponsors & Collaborators

  • Joshua M Hare

    lead OTHER

Principal Investigators

  • Matthias A Salathe, MD · ISCI / University of Miami / Division of Pulmonary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2027-09-30
Completion
2028-09-30
FDA Drug
Yes

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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 NCT03058068 on ClinicalTrials.gov