NCT02645305

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

December 21, 2015

Last Update Submit

December 30, 2015

Conditions

COPD

Keywords

Safety and EfficacyAdipose stem cellsStem Cell therapy

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • Respiration rate

    1 month, 6 months, 12 months

  • 6 min walk test

    1 month, 6 months, 12 months

  • rates of panic attacks

    1 month, 6 months, 12 months

  • CRP concentration

    6 months, 12 months

Study Arms (1)

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

Adipose derived stem cellsBIOLOGICAL

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.

Also known as: Adipose derived stem cells and platelet rich plasma, ADSC and PRP
Treatment

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 to 80, inclusive
  • A prior diagnosis of moderate to severe COPD
  • GOLD IIa, III, IV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh

Ho Chi Minh City, Vietnam

RECRUITING

Nguyen Tri Phuong Hospital

Ho Chi Minh City, Vietnam

RECRUITING

Van Hanh Hospital

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD.

Study Record Dates

First Submitted

December 21, 2015

First Posted

January 1, 2016

Study Start

June 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

January 1, 2016

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share

Locations

VN(3)