Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

Conditions
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COPD, Emphysema or COPD, Chronic Bronchitis

Intervention / Treatment
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* Procedure: Treatment Then Placebo
* Procedure: Placebo Then Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 0 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>Cohort A (Treatment Then Placebo group) 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. | Procedure: Treatment Then Placebo<br>* Cohort A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.<br>|
| Experimental: Cohort B<br>Cohort B (Placebo Then Treatment group) 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. | Procedure: Placebo Then Treatment<br>* Cohort B will receive placebo of normal saline infusion during round one then stem cells/PRP infusion during round two.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life Score | Change in QOL score from baseline to 3 months and 6 months following each treatment | 3 months, 6 months following each treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 | Change in FEV1 from baseline to 6 months post-treatment | 6 months following each treatment |