Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

NCT03228121 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-09-13

No results posted yet for this study

Summary

The aim of this randomized, controlled crossover designed study is to compare the outcomes of receiving autologous, adult stem cells versus placebo among participants with chronic obstructive pulmonary disease (COPD). The study is limited to self-funded participants with a diagnosis of COPD. The study, along with others at the Lung Institute, have received full review and approval of an Institutional Review Board.

Conditions

  • COPD
  • Emphysema or COPD
  • Chronic Bronchitis

Interventions

PROCEDURE

Treatment Then Placebo

Cohort A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.

PROCEDURE

Placebo Then Treatment

Cohort B will receive placebo of normal saline infusion during round one then stem cells/PRP infusion during round two.

Sponsors & Collaborators

  • Lung Institute

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2018-09-11
Completion
2018-09-11

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT03228121 on ClinicalTrials.gov