Adipose Derived Cells for Chronic Obstructive Pulmonary Disease
Status: | Withdrawn |
---|---|
Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 3/17/2017 |
Start Date: | January 2014 |
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
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).
safe and 2) Is treatment effective in improving the disease pathology of patients with
diagnosed with chronic obstructive pulmonary disease (COPD).
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.
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