Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

December 30, 2015 updated by: Phuc Van Pham, University of Science Ho Chi Minh City

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh, Vietnam
        • Recruiting
        • Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
        • Contact:
        • Principal Investigator:
          • Phuc V Pham, PhD
      • Ho Chi Minh, Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • Van Hanh Hospital
        • Contact:
        • Principal Investigator:
          • Phuong Le Thi Bich, MSc., MD
        • Principal Investigator:
          • Chien Vo Duc, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SGOT
Time Frame: 1 month
The blood SGOT levels are thus elevated with liver damage
1 month
SGPT
Time Frame: 1 month
The blood SGPT levels are thus elevated with liver damage
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiration rate
Time Frame: 1 month, 6 months, 12 months
1 month, 6 months, 12 months
6 min walk test
Time Frame: 1 month, 6 months, 12 months
1 month, 6 months, 12 months
rates of panic attacks
Time Frame: 1 month, 6 months, 12 months
1 month, 6 months, 12 months
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
6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Science Ho Chi Minh City

Collaborators

Van Hanh General Hospital
Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet Nam
GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 21, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2555/QD-BYT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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