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Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction

NCT02709343 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-12-06

No results posted yet for this study

Summary

This study is designed for lung transplant patients who have developed chronic lung allograft dysfunction (CLAD). Consented patients will receive 4 intravenous doses of allogeneic, bone-marrow-derived MSCs (2\*10\^6 cells/kg/dose) or matching placebo over a period of 2 weeks with a 12 month follow up.

Conditions

  • Chronic Lung Allograft Dysfunction (CLAD)

Interventions

DRUG

Bone-marrow derived MSCs

Allogeneic ex vivo expanded, bone marrow-derived mesenchymal stromal cells

DRUG

Placebo

Placebo product visually very similar to mesenchymal stromal cells

Sponsors & Collaborators

  • Isopogen

    collaborator UNKNOWN

  • Cell and Tissue Therapies

    collaborator UNKNOWN

  • The University of Queensland

    lead OTHER

Principal Investigators

  • Daniel Chambers, MBBS MD · University of Queensland & The Prince Charles Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-21
Primary Completion
2023-09-13
Completion
2023-10-25

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT02709343 on ClinicalTrials.gov