Adipose Derived Cells for Chronic Obstructive Pulmonary Disease
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 100
Inclusion Criteria
- Age between 18 and 85 years
- GOLD III and IV
- A prior diagnosis of moderate or severe COPD
- Age between 18 and 85 years
- GOLD III and IV
- A prior diagnosis of moderate or severe COPD
Exclusion Criteria
- Severe asthma that would contraindicate surgery
- 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.
- ...
- Severe asthma that would contraindicate surgery
- 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 on chronic immunosuppressive transplant therapy
- 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.
- Life expectancy < 6 months due to concomitant illnesses.
- 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
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Patients with Alpha-1
- 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.
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
- Age between 18 and 85 years
- GOLD III and IV
- A prior diagnosis of moderate or severe COPD
- Age between 18 and 85 years
- GOLD III and IV
- A prior diagnosis of moderate or severe COPD
Exclusion Criteria
- Severe asthma that would contraindicate surgery
- 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.
- ...
- Severe asthma that would contraindicate surgery
- 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 on chronic immunosuppressive transplant therapy
- 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.
- Life expectancy < 6 months due to concomitant illnesses.
- 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
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Patients with Alpha-1
- 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.
Tracking Information
- NCT #
- NCT02041000
- Collaborators
- Not Provided
- Investigators
- Study Director: Kristin Comella Bioheart, Inc.
- Study Director: Kristin Comella Bioheart
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