Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD
Stopped early · Phase 1
Conditions studied: Chronic Obstructive Pulmonary Disease
In brief
The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose derived stem cells (aADSC) administered intravenously in patients with chronic obstructive pulmonary disease, and 2.- to assess if this therapy results in less decrease of lung function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control baseline of 6 weeks. Patients will be followed up for 12 months after the therapy.
Key facts
- Study ID
- NCT02161744
- Run by
- Arkansas Heart Hospital
- People needed
- 9
- Starts
- 2013-10-10
- Expected to finish
- 2018-10-29
- Last updated by the study team
- 2020-01-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and Females ≥18 years.
- Cognitive competitiveness.
- Diagnosis of at least moderate COPD (postbronchodilator FEV1/FVC < 70% (<0.7), FEV1 < 80% predicted).
- Diffusing capacity impairment (DLCO) assessed by single breath test (corrected for alveolar volume, 'DLVA').
- Life expectancy greater than 12 months.
- Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf.
- Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits.
- No changes in active pulmonary medications for heart failure during the two weeks prior enrollment.
- Written informed consent. 11. Non-smoker or Past smoker, with 20 pack-years or more history
You may not qualify if…
- Current smokers.
- Unstable coronary disease.
- Patients with industrial exposure to silica and/or asbestos or giant bullae.
- Uncontrolled seizure disorder.
- Dementia.
- Presence of immune deficiency or autoimmune disease.
- Alpha- 1 antitrypsin deficiency.
- Cor pulmonale or diastolic heart failure NYHA class III or IV
- Type 1 diabetes mellitus
- Complicated type 2 diabetes mellitus.
- Active tuberculosis or severe lung damage due to tuberculosis (extensive cavitation).
- History of cancer within the past 5 years.
- Clinically-significant hematologic, hepatic, or renal impairment as determined by screening clinical laboratory tests.
- Systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study treatment.
- Porphyria.
- Allergy to sodium citrate or any "caine" type of local anesthetic.
- Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as patients undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury.
Where it is running
- Arkansas Heart Hospital — Little Rock, Arkansas, United States
- Arkansas Site Management Services LLC — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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