https://clinicaltrials.gov/ct2/show/study/NCT01796392?term=Emphysema&rank=42#locn
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed with chronic obstructive pulmonary disease (COPD).
Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Adipose Derived Stem Cells
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Chronic Obstructive Pulmonary Disease
Resource links provided by NLM:
MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources
Further study details as provided by Bioheart, Inc.:
Primary Outcome Measures:
Safety [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety will be assessed as the occurrence/frequency (if applicable) of adverse events during the study procedures and for up to 6 months afterward.
St. George Respiratory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The St. George Respiratory questionnaire is an index developed to identify the quality of life of patients by measuring and quantifying health-related health status of patients with airflow obstruction.
Secondary Outcome Measures:
Gold Classification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The GOLD COPD staging system classifies people with COPD based on their degree of airflow limitation (obstruction). The airflow limitation is measured during pulmonary function tests
6 Minute Walk Test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Exercise capacity as measured as the distance a patient can walk over a 6 minute time period.
Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Eligibility
Ages Eligible for Study: 18 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
A prior diagnosis of moderate or severe COPD
GOLD III and IV
Age between 18 and 85 years
Exclusion Criteria:
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
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.
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
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
Patients on chronic immunosuppressive transplant therapy
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
History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Patients with Alpha-1
Unwilling and/or not able to give written informed consent.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02041000
Contacts
Contact: Kristin Comella kcomella@bioheartinc.com
Locations
United States, Florida
Bioheart Recruiting
Miami, Florida, United States, 33166
Contact: Kristin Comella 813-390-9874 kcomella@bioheartinc.com
Sponsors and Collaborators
Bioheart, Inc.
Investigators
Study Director: Kristin Comella Bioheart, Inc.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed with chronic obstructive pulmonary disease (COPD).
Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Adipose Derived Stem Cells
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Chronic Obstructive Pulmonary Disease
Resource links provided by NLM:
MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources
Further study details as provided by Bioheart, Inc.:
Primary Outcome Measures:
Safety [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety will be assessed as the occurrence/frequency (if applicable) of adverse events during the study procedures and for up to 6 months afterward.
St. George Respiratory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The St. George Respiratory questionnaire is an index developed to identify the quality of life of patients by measuring and quantifying health-related health status of patients with airflow obstruction.
Secondary Outcome Measures:
Gold Classification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The GOLD COPD staging system classifies people with COPD based on their degree of airflow limitation (obstruction). The airflow limitation is measured during pulmonary function tests
6 Minute Walk Test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Exercise capacity as measured as the distance a patient can walk over a 6 minute time period.
Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Eligibility
Ages Eligible for Study: 18 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
A prior diagnosis of moderate or severe COPD
GOLD III and IV
Age between 18 and 85 years
Exclusion Criteria:
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
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.
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
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
Patients on chronic immunosuppressive transplant therapy
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
History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Patients with Alpha-1
Unwilling and/or not able to give written informed consent.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02041000
Contacts
Contact: Kristin Comella kcomella@bioheartinc.com
Locations
United States, Florida
Bioheart Recruiting
Miami, Florida, United States, 33166
Contact: Kristin Comella 813-390-9874 kcomella@bioheartinc.com
Sponsors and Collaborators
Bioheart, Inc.
Investigators
Study Director: Kristin Comella Bioheart, Inc.