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NCT02161744

Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD

Terminated Phase 1 Last updated 27 January 2020
What this trial tests

Phase 1 trial testing ADSCs administration in Chronic Obstructive Pulmonary Disease in 9 participants. Terminated before completion.

Timeline
10 October 2013
Primary endpoint
29 October 2018
29 October 2018

Quick facts

Lead sponsorArkansas Heart Hospital
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date10 October 2013
Primary completion29 October 2018
Estimated completion29 October 2018
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Arkansas Heart Hospital

Who can join

18 and older, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose derived stem cells (aADSC) administered intravenously in patients with chronic obstructive pulmonary disease, and 2.- to assess if this therapy results in less decrease of lung function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control baseline of 6 weeks. Patients will be followed up for 12 months after the therapy.

Publications & conference data

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

  1. Fat Therapeutics: The Clinical Capacity of Adipose-Derived Stem Cells and Exosomes for Human Disease and Tissue Regeneration.
    Shukla L, Yuan Y, Shayan R, Greening DW, et al · · 2020 · cited 129× · PMID 32194404 · DOI 10.3389/fphar.2020.00158
  2. Concise Review: Fat and Furious: Harnessing the Full Potential of Adipose-Derived Stromal Vascular Fraction.
    Dykstra JA, Facile T, Patrick RJ, Francis KR, et al · · 2017 · cited 77× · PMID 28186685 · DOI 10.1002/sctm.16-0337
  3. Mesenchymal stromal cells: a novel therapy for the treatment of chronic obstructive pulmonary disease?
    Broekman W, Khedoe PPSJ, Schepers K, Roelofs H, et al · · 2018 · cited 65× · PMID 29653970 · DOI 10.1136/thoraxjnl-2017-210672
  4. Adipose Stem Cell Translational Applications: From Bench-to-Bedside.
    Argentati C, Morena F, Bazzucchi M, Armentano I, et al · · 2018 · cited 63× · PMID 30400641 · DOI 10.3390/ijms19113475
  5. Preclinical Studies of Mesenchymal Stem Cell (MSC) Administration in Chronic Obstructive Pulmonary Disease (COPD): A Systematic Review and Meta-Analysis.
    Liu X, Fang Q, Kim H. · · 2016 · cited 45× · PMID 27280283 · DOI 10.1371/journal.pone.0157099
  6. Mesenchymal Stem Cell Administration in Patients with Chronic Obstructive Pulmonary Disease: State of the Science.
    Cheng SL, Lin CH, Yao CL. · · 2017 · cited 27× · PMID 28303154 · DOI 10.1155/2017/8916570
  7. Stem cell therapy for chronic obstructive pulmonary disease.
    Chen YT, Miao K, Zhou L, Xiong WN. · · 2021 · cited 22× · PMID 34250959 · DOI 10.1097/cm9.0000000000001596
  8. Current therapeutic strategies for respiratory diseases using mesenchymal stem cells.
    Wang MY, Zhou TY, Zhang ZD, Liu HY, et al · · 2021 · cited 21× · PMID 34766151 · DOI 10.1002/mco2.74

Verify or expand the search:

Other recruiting trials for Chronic Obstructive Pulmonary Disease

Currently open trials in the same condition.

Other Arkansas Heart Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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