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Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
This study is currently recruiting participants.
Verified December 2015 by Phuc Van Pham, University of Science Ho Chi Minh City
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
Information provided by (Responsible Party):
Phuc Van Pham, University of Science Ho Chi Minh City
ClinicalTrials.gov Identifier:
NCT02645305
First received: December 21, 2015
Last updated: December 30, 2015
Last verified: December 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| COPD | Biological: Adipose derived stem cells | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Safety and Efficacy of Autologous Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease |
Resource links provided by NLM:
Further study details as provided by Phuc Van Pham, University of Science Ho Chi Minh City:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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 ]The CRP concentration in the patients were evaluated before and after treatment for 6 and 12 months
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2015 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02645305
Please refer to this study by its ClinicalTrials.gov identifier: NCT02645305
Locations
| Vietnam | |
| Van Hanh Hospital | Recruiting |
| Ho Chi Minh City, Vietnam | |
| Contact: Phuong Le Thi Bich, MSc., MD drbichphuong@gmail.com | |
| Principal Investigator: Phuong Le Thi Bich, MSc., MD | |
| Principal Investigator: Chien Vo Duc, MD. | |
| Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh | Recruiting |
| Ho Chi Minh, Vietnam | |
| Contact: Phuc V Pham, PhD +84903870153 pvphuc@hcmuns.edu.vn | |
| Principal Investigator: Phuc V Pham, PhD | |
| Nguyen Tri Phuong Hospital | Recruiting |
| Ho Chi Minh, Vietnam | |
| Contact: Chien Vo Duc, MD. myhanhchien@gmail.com | |
Sponsors and Collaborators
University of Science Ho Chi Minh City
Van Hanh General Hospital
Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet Nam
GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam
More Information
| Responsible Party: | Phuc Van Pham, MSc, PhD., University of Science Ho Chi Minh City |
| ClinicalTrials.gov Identifier: | NCT02645305 History of Changes |
| Other Study ID Numbers: |
2555/QD-BYT |
| Study First Received: | December 21, 2015 |
| Last Updated: | December 30, 2015 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Phuc Van Pham, University of Science Ho Chi Minh City:
|
Safety and Efficacy Adipose stem cells Stem Cell therapy |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 23, 2017