Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02645305
• Date of registration: 21/12/2015
• Prospective Registration: No
• Primary sponsor: University of Science Ho Chi Minh City
• Public title: Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
• Scientific title: Evaluation of Safety and Efficacy of Autologous Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
• Date of first enrolment: June 2015
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02645305
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Vietnam

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

COPD

Intervention(s)

Biological: Adipose derived stem cells

Primary Outcome(s)

SGOT [Time Frame: 1 month]

SGPT [Time Frame: 1 month]

Secondary Outcome(s)

CRP concentration [Time Frame: 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]

Respiration rate [Time Frame: 1 month, 6 months, 12 months]

Secondary ID(s)

2555/QD-BYT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam

Van Hanh General Hospital

Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet Nam