Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, pulmonary, stem cells, emphysema, lungs
Brief summary
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).
Interventions
Sponsors
Bioheart, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 months | 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 | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Gold Classification | 6 months | 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 | 6 months | Exercise capacity as measured as the distance a patient can walk over a 6 minute time period. |
Countries
United States
Outcome results
None listed