Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

NCT03228121 | Withdrawn

• 1 other identifier: LI003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Emphysema or COPD; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in FEV1

  6 months following each treatment

Study Arms (2)

Cohort A

EXPERIMENTAL

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

Cohort B

EXPERIMENTAL

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

Interventions

Treatment Then Placebo PROCEDURE

Cohort A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.

Cohort A

Placebo Then Treatment PROCEDURE

Cohort B will receive placebo of normal saline infusion during round one then stem cells/PRP infusion during round two.

Cohort B

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lung Institute: lead

Study Sites (1)

Lung Institute Dallas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the on-site PI and research nurse administering the treatment or placebo will know which group the participant belongs to. Patients are blinded. All follow-up contact and measurement of outcomes will be done by off-site research nurses who are blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: April 24, 2017
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)