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Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

Primary Purpose

COPD

Status
Unknown status
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
Adipose derived stem cells
Sponsored by
University of Science Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Safety and Efficacy, Adipose stem cells, Stem Cell therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Van Hanh HospitalRecruiting
  • Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi MinhRecruiting
  • Nguyen Tri Phuong HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients.

Outcomes

Primary Outcome Measures

SGOT
The blood SGOT levels are thus elevated with liver damage
SGPT
The blood SGPT levels are thus elevated with liver damage

Secondary Outcome Measures

Respiration rate
6 min walk test
rates of panic attacks
CRP concentration
The CRP concentration in the patients were evaluated before and after treatment for 6 and 12 months

Full Information

First Posted
December 21, 2015
Last Updated
December 30, 2015
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
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1. Study Identification

Unique Protocol Identification Number
NCT02645305
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Safety and Efficacy, Adipose stem cells, Stem Cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients.
Intervention Type
Biological
Intervention Name(s)
Adipose derived stem cells
Other Intervention Name(s)
Adipose derived stem cells and platelet rich plasma, ADSC and PRP
Intervention Description
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.
Primary Outcome Measure Information:
Title
SGOT
Description
The blood SGOT levels are thus elevated with liver damage
Time Frame
1 month
Title
SGPT
Description
The blood SGPT levels are thus elevated with liver damage
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Respiration rate
Time Frame
1 month, 6 months, 12 months
Title
6 min walk test
Time Frame
1 month, 6 months, 12 months
Title
rates of panic attacks
Time Frame
1 month, 6 months, 12 months
Title
CRP concentration
Description
The CRP concentration in the patients were evaluated before and after treatment for 6 and 12 months
Time Frame
6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Van Hanh Hospital
City
Ho Chi Minh City
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phuong Le Thi Bich, MSc., MD
Email
drbichphuong@gmail.com
First Name & Middle Initial & Last Name & Degree
Phuong Le Thi Bich, MSc., MD
First Name & Middle Initial & Last Name & Degree
Chien Vo Duc, MD.
Facility Name
Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
City
Ho Chi Minh
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phuc V Pham, PhD
Phone
+84903870153
Email
pvphuc@hcmuns.edu.vn
First Name & Middle Initial & Last Name & Degree
Phuc V Pham, PhD
Facility Name
Nguyen Tri Phuong Hospital
City
Ho Chi Minh
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien Vo Duc, MD.
Email
myhanhchien@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

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