Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

NCT ID: NCT02645305

Last Updated: 2016-01-01

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Adipose derived stem cells

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Adipose derived stem cells and platelet rich plasma ADSC and PRP

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Van Hanh General Hospital

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam

UNKNOWN

Sponsor Role collaborator

University of Science Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

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Phuc Van Pham

MSc, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Nguyen Tri Phuong Hospital

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Van Hanh Hospital

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Facility Contacts

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Phuc V Pham, PhD

Role: primary

+84903870153

Chien Vo Duc, MD.

Role: primary

Phuong Le Thi Bich, MSc., MD

Role: primary

Other Identifiers

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2555/QD-BYT

Identifier Type: -

Identifier Source: org_study_id

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