Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Safety and Efficacy of Autologous Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

Conditions
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COPD

Intervention / Treatment
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* Biological: Adipose derived stem cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients. | Biological: Adipose derived stem cells<br>* 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.<br>* Other names: ADSC and PRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 |  | 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 | 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety and Efficacy, Adipose stem cells, Stem Cell therapy