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NCT03044431

Autologous Stem Cell Treatment for Chronic Lung Disease Study

Completed Results posted Last updated 15 October 2018
What this trial tests

trial testing Cell therapy in COPD in 207 participants. Completed in 9 June 2017.

Timeline
1 April 2016
Primary endpoint
1 June 2017
9 June 2017

Quick facts

Lead sponsorLung Institute
StatusCompleted
Study typeOBSERVATIONAL
Enrollment207
Start date1 April 2016
Primary completion1 June 2017
Estimated completion9 June 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Lung Institute

Who can join

16 and older, any sex, with COPD or Interstitial Lung Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in FEV1 From Baseline Among COPD Patients Primary · Measurements pre-treatment and then at 6 months post- treatment

Change from baseline (among COPD patients only) as measured by pulmonary function testing/spirometry at baseline and again at 6 months post- treatment

GroupValue95% CI
Cell Therapy Treated12.80 – 100
Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses Primary · Measurements pre-treatment and then at 3 months post-treatment for all diagnoses

Number of patients in the total sample who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).

GroupValue95% CI
Cell Therapy Treated121
Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses Primary · Measurements pre-treatment and then at 6 months post-treatment among all diagnoses

Number of patients in the total sample who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).

GroupValue95% CI
Cell Therapy Treated90
Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores Secondary · Measurements for COPD pre-treatment and then at 3 months post-treatment

Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).

GroupValue95% CI
Cell Therapy Treated102
Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores Secondary · Measurements for COPD pre-treatment and then at 6 months post-treatment

Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).

GroupValue95% CI
Cell Therapy Treated79
Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores Secondary · Measurements for ILD pre-treatment and then at 3 months post-treatment

Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).

GroupValue95% CI
Cell Therapy Treated20
Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores Secondary · Measurements for ILD pre-treatment and then at 6 months post-treatment

Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).

GroupValue95% CI
Cell Therapy Treated13

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events monitoring and reporting was done over the entire length of the study, approximately 11 months from March 2016 through December 2016.. Reporting threshold: 0.2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cell Therapy Treated
Serious: 0/207 (0%)
Deaths: 4/207
Other adverse events (3 terms — click to expand)

ReactionSystemCell Therapy Treated
DizzinessSurgical and medical procedures
HypotensionCardiac disorders
Bradycardia, not procedure relatedCardiac disorders

Data from ClinicalTrials.gov NCT03044431 adverse events section.

Sponsor's own description

The purpose of the Lung Institute is to collect and isolate a patient's own cells and platelet rich plasma (PRP) and deliver the product back to the patient the same day. Lung Institute's treatment is limited to self-funded patients with chronic lung disease- chronic obstructive pulmonary disease (COPD) and restrictive lung diseases such as pulmonary fibrosis (PF) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are harvested through venous or bone marrow collection techniques. The hypothesized outcomes of therapy are safety and minimization of adverse events, a perceived improvement in the patient's lung condition (to be determined by their perceived quality of life), an improvement in the FEV1 among COPD patients, the ability to reduce supplemental oxygen use, the ability to function well without the use of rescue inhalers, reduction of secondary pulmonary infections, reduction in emergency room visits and exacerbations related to their disease.

Publications & conference data

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

  1. 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
  2. Stem Cell-Based Regenerative Therapy and Derived Products in COPD: A Systematic Review and Meta-Analysis.
    Calzetta L, Aiello M, Frizzelli A, Camardelli F, et al · · 2022 · cited 13× · PMID 35681492 · DOI 10.3390/cells11111797
  3. Regenerative and translational medicine in COPD: hype and hope.
    Guarnier LP, Moro LG, Lívero FADR, de Faria CA, et al · · 2023 · cited 11× · PMID 37495247 · DOI 10.1183/16000617.0223-2022
  4. Can Youthful Mesenchymal Stem Cells from Wharton's Jelly Bring a Breath of Fresh Air for COPD?
    Janczewski AM, Wojtkiewicz J, Malinowska E, Doboszyńska A. · · 2017 · cited 8× · PMID 29156550 · DOI 10.3390/ijms18112449
  5. Examining the potentials of stem cell therapy in reducing the burden of selected non-communicable diseases in Africa.
    Atewologun FA, Okesanya OJ, Okon II, Kayode HH, et al · · 2024 · cited 5× · PMID 39135088 · DOI 10.1186/s13287-024-03864-4

Verify or expand the search:

Other trials of Cell therapy

Trials testing the same drug.

Other recruiting trials for COPD

Currently open trials in the same condition.

Other Lung Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03044431.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing