Back to resultsSafety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ADSCs administration
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Adipose derived stem cells, Stromal vascular fraction cells, Pulmonary Function Tests, Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
10. Written informed consent. 11. Non-smoker or Past smoker, with 20 pack-years or more history
Exclusion Criteria:
- 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.
Sites / Locations
- Arkansas Heart Hospital
- Arkansas Site Management Services LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADSCs administration
Arm Description
Patients with Chronic Obstructive Pulmonary Disease will be treated with a single dose of autologous adipose derived stem cells. Stem cells will be isolated using standard Lipoaspiration procedure under sterile conditions.
Outcomes
Primary Outcome Measures
Safety of adipose derived stem cells (ADSC) in Patient with COPD
Safety/tolerability of Adipose Derived Stem Cell (ADSC) in patients with Chronic Obstructive Pulmonary Disease (COPD) during the twelve-month study period as determined by the incidence and severity of of adverse events.
Secondary Outcome Measures
Efficacy of ADSC in improving Shortness of Breath (SOB)
The change (decrease) in patient Shortness Of Breath (SOB) as compared to baseline, measured in breath per minute, after administration of adipose derived stem cells (ADSC)
Efficacy of ADSC In Pulmonary Function Test (PFTs)
The change (improvement) in Pulmonary Function Test (PFTs) after administration of adipose derived stem cells (ADSC) as compared to baseline.
Efficacy of adipose derived stem cell in 6 MWT
Improvement in patient ability to walk as measure using a 6 minute walk test ( in meter) as compared to baseline
Efficacy of adipose derived stem cells in patient's perceived exertion.
The change from baseline in patient perceived exertion as measure using the modified BORG scale or Rate of perceive exertion (RPE) which ranges from 1(no perceived exertion at all) to 10 (maximum perceived exertion)
Efficacy in Quality of life using George's Respiratory Questionnaire
The change from baseline in patient quality of life as measure using the George's Respiratory Questionnaire
Efficacy in Quality of life using the Chronic Respiratory questionnaires
The change from baseline in patient quality of life as measure using the Chronic Respiratory Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02161744
Brief Title
Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD
Official Title
A Phase I Open- Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Autologous Adipose Stem Cell (Adult Human) to Subjects With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
October 10, 2013 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
October 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Heart Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
STUDY DESIGN This is a Phase I open- label single-dose study in subjects with significant COPD. This is an expanded safety cohort. The investigators will enroll a minimum of 30 subjects. 6 week data of FEV1, FEV1/FVC, DLCO and 6 min walking distance values will be collected in all patients who are enrolled in the study (Baseline and 6 weeks after). Prior to the stem cell treatment, the patient will be assessed for 6 weeks by pulmonary function tests and 6 min walk tests. Then, patients will receive the infusion of stromal vascular fraction cells containing the aADSC (single intravenous dose). The standard therapy of COPD patients will not be interrupted during the duration of the study. Safety will be monitored on an ongoing basis, and an interim safety review will be conducted by the Investigator(s) and Sponsor after the first 20 patients have been enrolled and treated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Adipose derived stem cells, Stromal vascular fraction cells, Pulmonary Function Tests, Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Phase I open label study to assess safety and tolerability
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADSCs administration
Arm Type
Experimental
Arm Description
Patients with Chronic Obstructive Pulmonary Disease will be treated with a single dose of autologous adipose derived stem cells. Stem cells will be isolated using standard Lipoaspiration procedure under sterile conditions.
Intervention Type
Biological
Intervention Name(s)
ADSCs administration
Other Intervention Name(s)
Autologous Adipose Derived Stem Cells
Intervention Description
100- 240 cc of lipoaspirate will be extracted from the patient. The stromal vascular fraction (SVF) will be isolated with minimal manipulation. The cell pellet will be reconstituted in saline solution and administered intravenously to the patient.
Primary Outcome Measure Information:
Title
Safety of adipose derived stem cells (ADSC) in Patient with COPD
Description
Safety/tolerability of Adipose Derived Stem Cell (ADSC) in patients with Chronic Obstructive Pulmonary Disease (COPD) during the twelve-month study period as determined by the incidence and severity of of adverse events.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy of ADSC in improving Shortness of Breath (SOB)
Description
The change (decrease) in patient Shortness Of Breath (SOB) as compared to baseline, measured in breath per minute, after administration of adipose derived stem cells (ADSC)
Time Frame
2, 6 and 12 months
Title
Efficacy of ADSC In Pulmonary Function Test (PFTs)
Description
The change (improvement) in Pulmonary Function Test (PFTs) after administration of adipose derived stem cells (ADSC) as compared to baseline.
Time Frame
2, 6, 12 months
Title
Efficacy of adipose derived stem cell in 6 MWT
Description
Improvement in patient ability to walk as measure using a 6 minute walk test ( in meter) as compared to baseline
Time Frame
2, 6, 12 months
Title
Efficacy of adipose derived stem cells in patient's perceived exertion.
Description
The change from baseline in patient perceived exertion as measure using the modified BORG scale or Rate of perceive exertion (RPE) which ranges from 1(no perceived exertion at all) to 10 (maximum perceived exertion)
Time Frame
2, 6, 12 months
Title
Efficacy in Quality of life using George's Respiratory Questionnaire
Description
The change from baseline in patient quality of life as measure using the George's Respiratory Questionnaire
Time Frame
2, 6, 12 months
Title
Efficacy in Quality of life using the Chronic Respiratory questionnaires
Description
The change from baseline in patient quality of life as measure using the Chronic Respiratory Questionnaire
Time Frame
2, 6, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
10. Written informed consent. 11. Non-smoker or Past smoker, with 20 pack-years or more history
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Holder, MD
Organizational Affiliation
Arkansas Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Arkansas Site Management Services LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
12. IPD Sharing Statement
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Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD
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