Trial | NCT02645305  Report issue

Title

Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
Evaluation of Safety and Efficacy of Autologous Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Indication/Condition

    COPD

  • Study Participants

    20
Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases including chronic bronchitis, emphysema and chronic obstructive airways disease. People with COPD have difficulties breathing, primarily due to the narrowing of their airways, this is called airflow obstruction.

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.
Study Started
Jun 30
2015
Primary Completion
Sep 30
2016
Anticipated
Study Completion
Dec 31
2016
Anticipated
Last Update
Jan 01
2016
Estimate

Biological 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 names: Adipose derived stem cells and platelet rich plasma, ADSC and PRP

Treatment Experimental

Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients.

Criteria 

Inclusion Criteria:

Age 40 to 80, inclusive
A prior diagnosis of moderate to severe COPD
GOLD IIa, III, IV

Exclusion Criteria:

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
No Results Posted