Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
100

Inclusion Criteria

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
GOLD III and IV
Age between 18 and 85 years

Exclusion Criteria

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.
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Unwilling and/or not able to give written informed consent.
...
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.
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Unwilling and/or not able to give written informed consent.
Patients with Alpha-1
History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
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
Life expectancy < 6 months due to concomitant illnesses.
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.
Patients on chronic immunosuppressive transplant therapy
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
Severe asthma that would contraindicate surgery

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

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
GOLD III and IV
Age between 18 and 85 years

Exclusion Criteria

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.
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Unwilling and/or not able to give written informed consent.
...
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.
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Unwilling and/or not able to give written informed consent.
Patients with Alpha-1
History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
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
Life expectancy < 6 months due to concomitant illnesses.
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.
Patients on chronic immunosuppressive transplant therapy
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
Severe asthma that would contraindicate surgery

Tracking Information

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