Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
NCT ID: NCT02645305
Last Updated: 2016-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2015-06-30
2016-12-31
Brief Summary
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Some preclinical evaluations showed that COPD is closely related to chronic inflammation; therefore, this study aimed to use adipose-derived stem cells (ADSCs) in the form of non-expanded culture - that usually names as a stromal vascular fraction (SVF) in combination with activated platelet rich plasma (PRP) to treat this disease. Both SVF and PRP are autologous sources that obtained from adipose tissue and peripheral blood, respectively. This mixture is intravenously transfused into the patients.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients.
Adipose derived stem cells
Adipose derived stem cells that are isolated from adipose tissue are mesenchymal stem cells with high immune modulation capacity. Therefore, they can effectively modulate the immune system.
Interventions
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Adipose derived stem cells
Adipose derived stem cells that are isolated from adipose tissue are mesenchymal stem cells with high immune modulation capacity. Therefore, they can effectively modulate the immune system.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A prior diagnosis of moderate to severe COPD
* GOLD IIa, III, IV
Exclusion Criteria
* 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
40 Years
80 Years
ALL
No
Sponsors
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Van Hanh General Hospital
OTHER
Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet Nam
UNKNOWN
GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam
UNKNOWN
University of Science Ho Chi Minh City
OTHER
Responsible Party
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Phuc Van Pham
MSc, PhD.
Locations
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Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
Ho Chi Minh City, , Vietnam
Nguyen Tri Phuong Hospital
Ho Chi Minh City, , Vietnam
Van Hanh Hospital
Ho Chi Minh City, , Vietnam
Countries
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Facility Contacts
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Other Identifiers
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2555/QD-BYT
Identifier Type: -
Identifier Source: org_study_id
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