Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
100

Inclusion Criteria

GOLD III and IV
Age between 18 and 85 years
A prior diagnosis of moderate or severe COPD
GOLD III and IV
Age between 18 and 85 years
A prior diagnosis of moderate or severe COPD

Exclusion Criteria

History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Patients on chronic immunosuppressive transplant therapy
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
...
History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Patients on chronic immunosuppressive transplant therapy
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
Severe asthma that would contraindicate surgery
Patients with Alpha-1
Life expectancy < 6 months due to concomitant illnesses.
Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
Unwilling and/or not able to give written informed consent.
Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results

Summary

Conditions
Chronic Obstructive Pulmonary Disease
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 85 years
Gender
Both males and females

Inclusion Criteria

GOLD III and IV
Age between 18 and 85 years
A prior diagnosis of moderate or severe COPD
GOLD III and IV
Age between 18 and 85 years
A prior diagnosis of moderate or severe COPD

Exclusion Criteria

History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Patients on chronic immunosuppressive transplant therapy
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
...
History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Patients on chronic immunosuppressive transplant therapy
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
Severe asthma that would contraindicate surgery
Patients with Alpha-1
Life expectancy < 6 months due to concomitant illnesses.
Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
Unwilling and/or not able to give written informed consent.
Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results

Locations

Sunrise, Florida
Sunrise, Florida

Tracking Information

NCT #
NCT02041000
Collaborators
Not Provided
Investigators
Study Director: Kristin Comella Bioheart, Inc.