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Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

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ClinicalTrials.gov Identifier: NCT03228121
Recruitment Status : Enrolling by invitation
First Posted : July 24, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Melissa Rubio, PhD, APRN, Lung Institute

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.

Condition or disease Intervention/treatment Phase
COPD Emphysema or COPD Chronic Bronchitis Procedure: Treatment Then Placebo Procedure: Placebo Then Treatment Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : May 24, 2018
Estimated Study Completion Date : November 24, 2018

Arm Intervention/treatment
Experimental: Cohort A
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 A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.

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




Primary Outcome Measures :
  1. Change in Quality of Life Score [ Time Frame: 3 months, 6 months following each treatment ]
    Change in QOL score from baseline to 3 months and 6 months following each treatment


Secondary Outcome Measures :
  1. Change in FEV1 [ Time Frame: 6 months following each treatment ]
    Change in FEV1 from baseline to 6 months post-treatment



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228121


Locations
United States, Texas
Lung Institute Dallas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Lung Institute

Responsible Party: Melissa Rubio, PhD, APRN, Principal Investigator, Lung Institute
ClinicalTrials.gov Identifier: NCT03228121     History of Changes
Other Study ID Numbers: LI003
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Emphysema
Bronchitis
Bronchitis, Chronic
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive