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Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

U

University of Science Ho Chi Minh City

Status and phase

Unknown
Phase 2
Phase 1

Conditions

COPD

Treatments

Biological: Adipose derived stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02645305
2555/QD-BYT

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Treatment
Experimental group
Description:
Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients.
Treatment:
Biological: Adipose derived stem cells

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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