Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

Last updated: September 11, 2018
Sponsor: Lung Institute
Overall Status: Trial Not Available

Phase

N/A

Condition

Copd (Chronic Obstructive Pulmonary Disease)

Chronic Bronchitis

Chronic Obstructive Lung Disease

Treatment

N/A

Clinical Study ID

NCT03228121
LI003
  • Ages > 16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 COPDdiagnosis are excluded.

Study Design

Study Start date:
April 24, 2017
Estimated Completion Date:
September 11, 2018

Study 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.

Connect with a study center

  • Lung Institute Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

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