Adipose Derived Stem Cells Transplantation for Chronic Ob... | NCT02645305

Studies
Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

NCT02645305

Sponsor

University of Science Ho Chi Minh City

Status

Unknown status

Last Update Posted

Jan 1, 2016Estimated

Enrollment

20Estimated

Phase

Phase 1Phase 2

Conditions

COPD

Interventions

Adipose derived stem cells

Countries

Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Sep 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Dec 21, 2015

First Submission Date that Met QC Criteria

Dec 30, 2015

First Posted Date

Jan 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2015

Last Update Posted Date

Jan 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Phuc Van Pham, MSc, PhD., University of Science Ho Chi Minh CityPrincipal Investigator

Lead Sponsor

University of Science Ho Chi Minh CityOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients.	Biological: Adipose derived stem cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adipose derived stem cells	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh	Recruiting	Ho Chi Minh City			Vietnam

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided