Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
COPD	Biological: Adipose derived stem cells	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evaluation of Safety and Efficacy of Autologous Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
Study Start Date :	June 2015
Estimated Primary Completion Date :	September 2016
Estimated Study Completion Date :	December 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Treatment; Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients.	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

Outcome Measures

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Primary Outcome Measures :

1. SGOT [ Time Frame: 1 month ]
   The blood SGOT levels are thus elevated with liver damage
2. SGPT [ Time Frame: 1 month ]
   The blood SGPT levels are thus elevated with liver damage

Secondary Outcome Measures :

1. Respiration rate [ Time Frame: 1 month, 6 months, 12 months ]
2. 6 min walk test [ Time Frame: 1 month, 6 months, 12 months ]
3. rates of panic attacks [ Time Frame: 1 month, 6 months, 12 months ]
4. CRP concentration [ Time Frame: 6 months, 12 months ]
   The CRP concentration in the patients were evaluated before and after treatment for 6 and 12 months

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Vietnam
Van Hanh Hospital	Recruiting
Ho Chi Minh City, Vietnam
Contact: Phuong Le Thi Bich, MSc., MD drbichphuong@gmail.com
Principal Investigator: Phuong Le Thi Bich, MSc., MD
Principal Investigator: Chien Vo Duc, MD.
Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh	Recruiting
Ho Chi Minh, Vietnam
Contact: Phuc V Pham, PhD +84903870153 pvphuc@hcmuns.edu.vn
Principal Investigator: Phuc V Pham, PhD
Nguyen Tri Phuong Hospital	Recruiting
Ho Chi Minh, Vietnam
Contact: Chien Vo Duc, MD. myhanhchien@gmail.com

Sponsors and Collaborators

University of Science Ho Chi Minh City

Van Hanh General Hospital

Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet Nam

GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Phuc Van Pham, MSc, PhD., University of Science Ho Chi Minh City
ClinicalTrials.gov Identifier:	NCT02645305 History of Changes
Other Study ID Numbers:	2555/QD-BYT
First Posted:	January 1, 2016
Last Update Posted:	January 1, 2016
Last Verified:	December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Phuc Van Pham, University of Science Ho Chi Minh City:

Safety and Efficacy; Adipose stem cells; Stem Cell therapy

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases