COPD Clinical Trial
Official title:
Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD
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.
The purpose of the Lung Institute is to collect, minimally process, and administer a person's
own stem cells and/or platelet rich plasma and deliver the product back to the patient
same-day through an intravenous catheter. This study is limited to patients diagnosed with
chronic obstructive pulmonary disease (COPD) and is a double-blinded prospective, cohort
trial using cross-over methodology. The aim of this study is to determine if stem cell
therapy is better than placebo among a group of patients with COPD.
50 participants will be recruited for each arm of the study.
Cohort A will receive three days of cell therapy using the venous procedure (three
consecutive days of blood harvest, cell separation and cell application). Cohort A will
return in three months and receive three consecutive days of placebo.
Cohort B will receive three consecutive days of placebo. Cohort B will return in three months
and receive three consecutive days of cell therapy using the venous procedure.
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