NCT02709343: ASSIST-CLAD

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

Completed Phase 2 Last updated 6 December 2023

What this trial tests

Phase 2 trial testing Bone-marrow derived MSCs in Chronic Lung Allograft Dysfunction (CLAD) in 64 participants. Completed in 25 October 2023.

Timeline

21 April 2017

Primary endpoint
13 September 2023

25 October 2023

Quick facts

Lead sponsor	The University of Queensland
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	64
Start date	21 April 2017
Primary completion	13 September 2023
Estimated completion	25 October 2023
Sites	5 locations across Australia

Drugs / interventions tested

• Bone-marrow derived MSCs
• Placebo

Conditions studied

• Chronic Lung Allograft Dysfunction (CLAD) — all drugs for Chronic Lung Allograft Dysfunction (CLAD) →

Sponsor

The University of Queensland

Who can join

18 and older, any sex, with Chronic Lung Allograft Dysfunction (CLAD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Developments in lung transplantation over the past decade.
   van der Mark SC, Hoek RAS, Hellemons ME. · · 2020 · cited 101× · PMID 32699023 · DOI 10.1183/16000617.0132-2019
2. Mesenchymal Stromal Cell Therapy for Chronic Lung Allograft Dysfunction: Results of a First-in-Man Study.
   Chambers DC, Enever D, Lawrence S, Sturm MJ, et al · · 2017 · cited 64× · PMID 28186707 · DOI 10.1002/sctm.16-0372
3. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
4. Novel approaches for long-term lung transplant survival.
   Miller CL, O JM, Allan JS, Madsen JC. · · 2022 · cited 20× · PMID 35967365 · DOI 10.3389/fimmu.2022.931251
5. Lung transplantation, <i>ex-vivo</i> reconditioning and regeneration: state of the art and perspectives.
   Rosso L, Zanella A, Righi I, Barilani M, et al · · 2018 · cited 16× · PMID 30123580 · DOI 10.21037/jtd.2018.04.151
6. Promising role for mesenchymal stromal cells in coronavirus infectious disease-19 (COVID-19)-related severe acute respiratory syndrome?
   Hamdan H, Hashmi SK, Lazarus H, Gale RP, et al · · 2021 · cited 11× · PMID 32854985 · DOI 10.1016/j.blre.2020.100742
7. Mesenchymal Stromal Cell Therapy in Lung Transplantation.
   Nykänen AI, Liu M, Keshavjee S. · · 2023 · cited 5× · PMID 37370659 · DOI 10.3390/bioengineering10060728