Status:
COMPLETED
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Kimera Society Inc
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
This will be an open-label, non-randomized multi-center study designed to assess the safety and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of cells isolated f...
Detailed Description
In the context of the proposed study, adipose derived stem cells (ASC) constitute an autologous cell product that is delivered to the patient via intra-venous injection. In this study, we propose to i...
Eligibility Criteria
Inclusion
- Age 18 to 85, inclusive
- A prior diagnosis of moderate to severe COPD
- GOLD IIa, III, IV
Exclusion
- Pregnant or lactating
- 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.
- Any illness which, in the Investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
- Subjects on chronic immunosuppressive or chemotherapeutic 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.
- Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease).
- Unwilling and/or not able to give written consent
- Patient is positive for hepatitis (past history of Hepatitis A is allowed)
- Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
- Cerebral aneurysm clips
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02216630
Start Date
August 1 2014
End Date
July 1 2017
Last Update
July 25 2017
Active Locations (5)
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1
Melvin Propis M.D.
Davie, Florida, United States, 33330
2
Chicago
Chicago, Illinois, United States, 60061
3
Las Vegas
Las Vegas, Nevada, United States, 89030
4
New York
New York, New York, United States, 10001