Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02645305
• Other study ID #: 2555/QD-BYT
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 21, 2015
• Last updated: December 30, 2015
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: University of Science Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Scientific and Ethic Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Vietnam	Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh	Ho Chi Minh
Vietnam	Nguyen Tri Phuong Hospital	Ho Chi Minh
Vietnam	Van Hanh Hospital	Ho Chi Minh City

Sponsors (4)

Lead Sponsor	Collaborator
University of Science Ho Chi Minh City	GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam, Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet Nam, Van Hanh General Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SGOT	The blood SGOT levels are thus elevated with liver damage	1 month	Yes
Primary	SGPT	The blood SGPT levels are thus elevated with liver damage	1 month	Yes
Secondary	Respiration rate		1 month, 6 months, 12 months	No
Secondary	6 min walk test		1 month, 6 months, 12 months	No
Secondary	rates of panic attacks		1 month, 6 months, 12 months	No
Secondary	CRP concentration	The CRP concentration in the patients were evaluated before and after treatment for 6 and 12 months	6 months, 12 months	No