Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

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.

Inclusion Criteria:

- Patients are included in treatment by self-referral and after consultation with a
designated patient coordinator who determines initial eligibility, and then by the
clinic nurse practitioner or physician of Lung Institute who determines final
eligibility for inclusion. Patients must be diagnosed with chronic obstructive
pulmonary disease (COPD) and be able to travel to the Dallas clinic location.

Exclusion Criteria:

- Patients who are unable to provide informed consent, pregnant patients, prisoners,
non-English speakers, patients with a history of cancer within the past 5 years,
patients with active tuberculosis or pneumonia. Patients without a documented COPD
diagnosis are excluded.