COPDPhase 1/2NCT02645305
Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
A Phase 1/2 study testing Adipose derived stem cells in people with COPD, run by University of Science Ho Chi Minh City at 3 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Adipose derived stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesVietnam
- Study dates
- Jun 2015to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 80, inclusive
- A prior diagnosis of moderate to severe COPD
- GOLD IIa, III, IV
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
Vietnam3 sites, 3 recruiting
- Recruiting
Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
Ho Chi Minh City
Phuc V Pham, PhD, +84903870153, pvphuc@hcmuns.edu.vn
Phuc V Pham, PhD
- Recruiting
Nguyen Tri Phuong Hospital
Ho Chi Minh City
Chien Vo Duc, MD., myhanhchien@gmail.com
- Recruiting
Van Hanh Hospital
Ho Chi Minh City
Phuong Le Thi Bich, MSc., MD, drbichphuong@gmail.com
Phuong Le Thi Bich, MSc., MD
About this study
Official title: 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.
- Conditions
- COPD
- Being tested
- Adipose derived stem cells
- Keywords
- Safety and Efficacy, Adipose stem cells, Stem Cell therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose derived stem cellsBiological
Also called Adipose derived stem cells and platelet rich plasma, ADSC and PRP
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients. Receives: Biological: Adipose derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
SGOT
The blood SGOT levels are thus elevated with liver damage
Measured: 1 month
SGPT
The blood SGPT levels are thus elevated with liver damage
Measured: 1 month
Secondary outcomes (4)
Respiration rate
Measured: 1 month, 6 months, 12 months
6 min walk test
Measured: 1 month, 6 months, 12 months
rates of panic attacks
Measured: 1 month, 6 months, 12 months
CRP concentration
The CRP concentration in the patients were evaluated before and after treatment for 6 and 12 months
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Science Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Collaborators
- Van Hanh General Hospital, Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet Nam, GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam
- Responsible party
- Principal investigator, Phuc Van Pham, University of Science Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645305
- Sponsor's protocol ID
- 2555/QD-BYT
- Status last verified
- Dec 2015
- First submitted
- 21 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Autologous Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02645305
- Acronym / sponsor ID
- 2555/QD-BYT
- Conditions
- COPD
- Keywords
- Safety and Efficacy, Adipose stem cells, Stem Cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Science Ho Chi Minh CityUniversity, hospital or other
- 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 start
- Jun 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Adipose derived stem cellsAutologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40 to 80, inclusive
- A prior diagnosis of moderate to severe COPD
- GOLD IIa, III, IV
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose derived stem cellsAlso: Adipose derived stem cells and platelet rich plasma, ADSC and PRPAdipose 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. | Biological | Treatment |
Primary outcome
SGOT
Time frame: 1 month
The blood SGOT levels are thus elevated with liver damage
SGPT
Time frame: 1 month
The blood SGPT levels are thus elevated with liver damage
4 secondary outcomes
Respiration rate
Time frame: 1 month, 6 months, 12 months
6 min walk test
Time frame: 1 month, 6 months, 12 months
rates of panic attacks
Time frame: 1 month, 6 months, 12 months
CRP concentration
Time frame: 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
Ho Chi Minh City, Vietnam
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adipose derived stem cells in people with COPD, run by University of Science Ho Chi Minh City at 3 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SGOT (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.