Adipose Derived Cells for Chronic Obstructive Pulmonary Disease
Last updated on April 2022Recruitment
- 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- Withdrawn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