Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

COPD Clinical Trial

Official title:

Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03228121
• Other study ID #: LI003
• Status: Withdrawn
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: September 11, 2018

Study information

• Verified date: September 2018
• Source: Lung Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• COPD
• Emphysema
• Emphysema or COPD

Intervention

Procedure:
• Treatment Then Placebo
Cohort A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.
• Placebo Then Treatment
Cohort B will receive placebo of normal saline infusion during round one then stem cells/PRP infusion during round two.

Locations

Country	Name	City	State
United States	Lung Institute Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lung Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in FEV1	Change in FEV1 from baseline to 6 months post-treatment	6 months following each treatment