Clinical trial NCT02645305: Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
Official title: Evaluation of Safety and Efficacy of Autologous Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: COPD
Keywords: Safety and Efficacy
Adipose stem cells
Stem Cell therapy
Lead sponsor: University of Science Ho Chi Minh City
Sponsor class: OTHER
Collaborators: name: Van Hanh General Hospital
name: Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet Nam
name: GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam
First posted: 2016-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: SGOT
timeFrame: 1 month
measure: SGPT
timeFrame: 1 month
Secondary outcomes:
measure: Respiration rate
timeFrame: 1 month, 6 months, 12 months
measure: 6 min walk test
timeFrame: 1 month, 6 months, 12 months
measure: rates of panic attacks
timeFrame: 1 month, 6 months, 12 months
measure: CRP concentration
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Van Hanh Hospital
city: Ho Chi Minh
country: Vietnam
facility: Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
city: Ho Chi Minh
country: Vietnam
facility: Nguyen Tri Phuong Hospital
Study officials:
References: