Chronic Obstructive Pulmonary DiseasePhase 1NCT02161744
Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD
A Phase 1 study testing ADSCs administration in people with Chronic Obstructive Pulmonary Disease, run by Arkansas Heart Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- ADSCs administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2013to 29 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Arkansas Site Management Services LLC
Little Rock, Arkansas, 72211
About this study
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
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- ADSCs administration
- Keywords
- Adipose derived stem cells, Stromal vascular fraction cells, Pulmonary Function Tests, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSCs administrationBiological
Also called Autologous Adipose Derived Stem Cells
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.
| Study group | Role | What they receive |
|---|---|---|
| ADSCs administration | Experimental | 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. Receives: Biological: ADSCs administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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)
Measured: 2, 6 and 12 months
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.
Measured: 2, 6, 12 months
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
Measured: 2, 6, 12 months
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)
Measured: 2, 6, 12 months
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
Measured: 2, 6, 12 months
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
Measured: 2, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study start10 Oct 2013
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I open label study to assess safety and tolerability
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Holder, MD, Principal investigator, Arkansas Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161744
- Sponsor's protocol ID
- ICMS-2013-25
- Status last verified
- Jan 2020
- First submitted
- 21 May 2014
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02161744
- Acronym / sponsor ID
- ICMS-2013-25
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Adipose derived stem cells, Stromal vascular fraction cells, Pulmonary Function Tests, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Arkansas Heart HospitalUniversity, hospital or other
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I open label study to assess safety and tolerability
| Arm | Type | Receives |
|---|---|---|
| ADSCs administration | Experimental | Biological: ADSCs administrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- Current smokers.
- Unstable coronary disease.
- Patients with industrial exposure to silica and/or asbestos or giant bullae.
- Uncontrolled seizure disorder.
- Dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADSCs administrationAlso: Autologous Adipose Derived Stem Cells100- 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. | Biological | ADSCs administration |
Primary outcome
Safety of adipose derived stem cells (ADSC) in Patient with COPD
Time frame: 12 months
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.
6 secondary outcomes
Efficacy of ADSC in improving Shortness of Breath (SOB)
Time frame: 2, 6 and 12 months
Efficacy of ADSC In Pulmonary Function Test (PFTs)
Time frame: 2, 6, 12 months
Efficacy of adipose derived stem cell in 6 MWT
Time frame: 2, 6, 12 months
Efficacy of adipose derived stem cells in patient's perceived exertion.
Time frame: 2, 6, 12 months
Efficacy in Quality of life using George's Respiratory Questionnaire
Time frame: 2, 6, 12 months
Efficacy in Quality of life using the Chronic Respiratory questionnaires
Time frame: 2, 6, 12 months
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Holder, MD principal investigator
Arkansas Heart Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADSCs administration in people with Chronic Obstructive Pulmonary Disease, run by Arkansas Heart Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of adipose derived stem cells (ADSC) in Patient with COPD (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.