Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD
NCT03228121 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2018-09-13
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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