NCT03228121

Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lung Institute · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• COPD
• Emphysema or COPD
• Chronic Bronchitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-24
• Primary completion: 2018-09-11
• Completion: 2018-09-11
• First posted: 2017-07-24
• Last updated: 2018-09-13

Locations

1 site across 1 country: United States